Intravenous Magnesium Sulfate Administration Reduces Propofol Infusion Requirements during Maintenance of Propofol–N2O Anesthesia

Background The authors investigated whether an intravenous administration of magnesium sulfate reduces propofol infusion requirements during maintenance of propofol-N2O anesthesia. Methods Part I study: 54 patients undergoing total abdominal hysterectomy were randomly divided into two groups (n = 27 per group). The patients in the control group received 0.9% sodium chloride solution, whereas the patients in the magnesium group received magnesium (50 mg/kg as a bolus, then 8 mg x kg(-1) x h(-1)). To maintain mean arterial blood pressure (MAP) and heart rate (HR) at baseline value, the propofol infusion rate was changed when the MAP or the HR changed. The amount of propofol infused excluding the bolus dosage was divided by patient's body weight and total infusion time. Part II study: Another 20 patients were randomly divided into two groups (n = 10 per group). When the MAP and HR had been maintained at baseline value and the propofol infusion rate had been maintained at 80 microg x kg(-1) x min(-1) (magnesium group) and 160 microg x kg(-1) x min(-1) (control group), bispectral index (BIS) values were measured. Results Part I: The mean propofol infusion rate in the magnesium group (81.81 +/- 13.09 microg x kg(-1) x min(-1)) was significantly less than in the control group (167.57 +/- 47.27). Part II: BIS values in the control group (40.70 +/- 3.89) were significantly less than those in the magnesium group (57.80 +/- 7.32). Conclusion Intravenous administration of magnesium sulfate reduces propofol infusion requirements. These results suggest that magnesium administration may have an effect on anesthesia or analgesia and may be a useful adjunct to propofol anesthesia.

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Efficacy of Magnesium Sulfate Added to Local Anesthetic in a Transversus Abdominis Plane Block for Analgesia Following Total Abdominal Hysterectomy: A Randomized Trial

January 2018 - Pain Physician ◽

10.36076/ppj.2017.7.641 ◽

2017 ◽

Vol 7 (20;7) ◽

pp. 641-647

Author(s):

Ahmad M. Abd El-Rahman

Keyword(s):

Side Effects ◽

Magnesium Sulfate ◽

Total Abdominal Hysterectomy ◽

Abdominal Hysterectomy ◽

Transversus Abdominis ◽

Tap Block ◽

Group I ◽

The Mean ◽

Group Ii ◽

Double Blinded

Background: Major abdominal surgeries are associated with severe pain, which can affect respiratory and cardiac functions if insufficiently treated; this increases postoperative morbidity. Objective: We aim at evaluating the efficacy of magnesium sulfate as an adjuvant to local anesthetic in an ultrasound-guided transversus abdominis plane (TAP) block for postoperative analgesia in total abdominal hysterectomy. Study Design: A prospective, randomized, double-blinded clinical trial. Setting: An academic medical center. Methods: This study is registered at https://clinicaltrials.gov (no.: NCT02930707). This randomized, double-blinded clinical trial included 60 women undergoing total abdominal hysterectomy that were divided into 2 groups (30 patients per group). Group I received a TAP block with 20 mL per side of 0.25% bupivacaine plus 2 mL magnesium sulphate 10% (200 mg). Group II received a TAP block with 20 mL per side of 0.25% bupivacaine. Visual analog scale (VAS) scores, the time of the first analgesic request, total morphine consumption, and any side effects were assessed and recorded. Results: The mean postoperative VAS score was significantly reduced in group I compared to group II in all of the time-points except after 10 hours. The mean time of the first request for rescue analgesia was significantly prolonged in group I (15.67 hrs.) compared to group II (7.33 hrs.) (P < 0.001), and the mean total morphine consumption, over the first 24 hours postoperatively, was significantly lower in group I (7.63 ± 2.93 mg) than in group II (16.20 ± 3.24 mg) (P < 0.001). No significant difference in side effects was observed. Limitations: Sample size. Conclusion: The addition of 200 mg of magnesium sulfate to bupivacaine in an ultrasound-guided TAP block significantly reduced postoperative opioid requirements, prolonged the duration of analgesia, and reduced the VAS score in patients who underwent abdominal hysterectomy, without significant side effects. Key words: Magnesium sulfate, TAP block, postoperative pain, total abdominal hysterectomy

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The correlation between Corrected Flow Time (FTc) Based on Esophageal Doppler Monitoring and Pleth Variability Index (PVI) in the Fluid Therapy in Patients undergoing Total Abdominal Hysterectomy

Archives of Anesthesia and Critical Care ◽

10.18502/aacc.v8i1.8243 ◽

2022 ◽

Author(s):

Alireza Saliminia ◽

Fatemeh Golpayegani

Keyword(s):

Fluid Therapy ◽

Total Abdominal Hysterectomy ◽

Abdominal Hysterectomy ◽

Blood Gas ◽

Total Fluid Intake ◽

Arterial Blood Gas ◽

Arterial Blood ◽

Significant Difference ◽

Duration Of Surgery ◽

The Mean

Background: The occurrence of bleeding during major surgeries is common and requires timely and accurate management in the prevention and treatment of hypovolemia and hemodynamic instability during and after surgery. This study evaluated the correlation and agreement between the two protocols determining the status of the hypovolemia during hysterectomy. Methods: This study was a randomized single-blinded clinical trial. The study population included 30 patients undergoing Total Abdominal Hysterectomy in Shariati Hospital in Tehran between 2015 and 2016. The patients were randomly assigned to two groups using a randomized table of numbers, so that in the FTc group, fluid therapy was performed based on the FTc index and in the PVI group based on the PVI index. The changes in FTc and PVI values were recorded every 5 minutes and the changes in the two indicators from the beginning to the end of the treatment were evaluated. At the beginning and end of the surgery, an arterial blood gas analysis (ABG) was also performed. The amount of bleeding during operation and urinary output were recorded in two groups. Results: There was no significant difference across the two groups in total fluid intake during surgery, mean volume of blood loss, mean urine output, and duration of surgery. The arterial blood gas status was also similar in both groups at the beginning and the end of the operation. We found a strong adverse correlation between FTC and PVI indices at the different time points evaluated within the surgery. In total, there was a strong correlation between the mean FTC and the mean PVI during the first hour (r=-0.765, P < 0.001) and the second hour (r=-0.941, -P < 0.001) of operation. Considering the cut-off point of 350msec for the FTC and 13% for the PVI in predicting hypovolemia, the agreement between the two protocols in fluid therapy during the first hour after surgery was 79.8% and 76.6%. Conclusion: There is a strong and significant correlation between the two FTC (with a cut off of 350) and PVI (with a cut point of 13%) to predict need for fluid therapy.

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Semi-Permanent Acupuncture Needles in the Prevention of Post-Operative Nausea and Vomiting

Acupuncture in Medicine ◽

10.1136/aim.14.2.68 ◽

1996 ◽

Vol 14 (2) ◽

pp. 68-70 ◽

Cited By ~ 8

Author(s):

J Andrzejowski ◽

D Woodward

Keyword(s):

Controlled Trial ◽

Total Abdominal Hysterectomy ◽

Abdominal Hysterectomy ◽

Nausea And Vomiting ◽

Control Group ◽

Study Group ◽

Median Score ◽

Severe Nausea ◽

Post Operative Nausea ◽

Trial Study Group

The efficacy of acupressure and acupuncture at the Pericardium 6 (PC.6) point in relieving post-operative nausea and vomiting (PONV) is well known. Lengthy manual stimulation of the needles, or electrostimulation, is inconvenient and incurs extra costs. The aim of this study was to test the effectiveness of the antiemetic action of semi-permanent acupuncture needles (SPANs), a cheap and convenient method of administering acupuncture, in the first 48 hours following gynaecological surgery. Patients (n = 36) having total abdominal hysterectomy were studied in a randomised, placebo controlled trial. Study group patients had SPANs inserted in PC.6 on both wrists. The control group had SPANs inserted into sham points on their forearms. There was no difference in the median nausea scores between the groups; however six patients suffered moderate or severe nausea during the second 24 hours in the control group, with none in the study group (p < 0.05). In addition, the nausea score between 8 and 24 hours in patients who had previously experienced PONV, was lower in the study group (median score 2) compared to the control group (median score 4) (p < 0.05). We conclude that the use of SPANs does not reduce the overall incidence of nausea and vomiting but does appear to reduce the severity of nausea in the second 24 hours, and has a greater effect on patients who had had nausea and vomiting after a previous anaesthetic.

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TAP Block in Postoperative Analgesia, A First Time Clinical Trial In Bangladesh

Journal of the Bangladesh Society of Anaesthesiologists ◽

10.3329/jbsa.v27i1.28992 ◽

2016 ◽

Vol 27 (1) ◽

pp. 3-11

Author(s):

Bidhan Paul ◽

Debashis Banik ◽

AKM Shamsul Alam

Keyword(s):

Postoperative Analgesia ◽

Total Abdominal Hysterectomy ◽

Abdominal Hysterectomy ◽

Transversus Abdominis ◽

Control Group ◽

Tap Block ◽

Analgesic Regimen ◽

Time Period ◽

Group A ◽

Group B

Background: In perioperative care, a reliable pain management is a vital appeal. Over recent years, Transversus Abdominis Plane (TAP) block is introduced as an important component of multimodal analgesia.Objective: To evaluate efficacy of TAP block in postoperative analgesia for Total Abdominal Hysterectomy (TAH) with subarachnoid block (SAB) in comparison of morphine consumption and VAS score.Methods: 60 patients were randomly allocated into 2 groups (TAP group-A & control group-B). Standard SAB was applied to all patients for elective TAH. Immediate after operation classical TAP block was performed through both Lumber Triangle Of Petit (LTOP) of group A patients. Both groups were placed in Post Anesthesia Care Unit (PACU), arranged a common standard postoperative analgesic regimen for all, observed periodically and documented it accordingly in pre-designed data sheet.Results: TAP block prolonged the mean time of 1st required I/V morphine (TAP vs control, mean±SD 271.23±40.34 vs 195.33±22.16 min., p=0.001HS). Morphine requirement was also reduced (17.4±5.4 vs 26.2±4.4 mg, p=0.001HS). Pain VAS scores at rest and movement were also reduced at all time period (p? 0.01 to 0.001). There was no complication attributed to the TAP block.Conclusion: TAP block provided considerably effective postoperative analgesia in first 24 hours after major abdominal surgery like TAH.Journal of Bangladesh Society of Anaesthesiologists 2014; 27(1): 3-11

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CLINICAL PROFILE AND MANAGEMENT OPTION OF FIBROID UTERUS PATIENTS OF OBSTETRICS AND GYNAECOLOGY DEPARTMENT OF DMCH, LAHERIASARAI, BIHAR

10.36106/ijsr/0137418 ◽

2020 ◽

pp. 1-2

Author(s):

Sangeeta Singh ◽

Renu Jha ◽

Seema Seema ◽

Debarshi Jana

Keyword(s):

Uterine Fibroids ◽

Total Abdominal Hysterectomy ◽

Abdominal Hysterectomy ◽

Management Options ◽

Fibroid Uterus ◽

Number Of Patients ◽

Study Results ◽

The Mean ◽

Benign Tumours ◽

Symptomatic Uterine Fibroid

Background: Fibroids are the most common benign tumours of smooth muscle cells of uterus in females and typically found during the middle and later reproductive years. As fibroid is an estrogen and progesterone dependent tumour, it gradually decreases in size during starting of menopause. The objective of this presented study was to determine management options among fibroid uterus patients. Methods: 50 number of patients were included in this study those who’s age of 20-55, with symptomatic uterine fibroid and undergone hysterectomy or myomectomy. Postmenopausal, Pregnancy and Asymptomatic fibroid were excluded from this study. Results: The study showed that 52 percent of patient having fibroid uterus were belonged to 31-40 years of age. The mean age was 41.2±6.07. The majority 74% of patients in this study presented with menstrual abnormalities, 40% presented with abdominal lump. Dysmenorrhoea was 26%, 6% patient had primary subfertility and 14% secondary subfertility. Total Abdominal Hysterectomy (TAH) with unilateral salpingo- oophorectomy done in 10% cases, TAH with bilateral salpino-oophorectomy in 22% cases, non descent vaginal hysterectomy in 6% cases, myomectomy done in 20% cases and polypectomy was done in 2% cases. Conclusion: Uterine fibroids are very common in women and frequently in late reproductive and perimenopausal years. It is also a common gynecological problem in our country, which frequently disturbs the lives of woman. Women now have choice of therapies for the treatment of fibroids.

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CORRELATION BETWEEN BODY MASS INDEX AND MICROALBUMINURIA IN ESSENTIAL HYPERTENSIVE ADULTS

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2020.v13i5.37075 ◽

2020 ◽

pp. 54-56

Author(s):

IRENGBAM SUSUPRIYA DEVI ◽

GLADYS RAI ◽

V. P. S PUNIA ◽

MANOJ KUMAR NANDKEOLIAR

Keyword(s):

Body Mass Index ◽

Body Mass ◽

Early Morning ◽

Mean Value ◽

Control Group ◽

Inclusion Criteria ◽

Hypertensive Patients ◽

Positive Correlation ◽

Arterial Blood ◽

The Mean

Objective: This study aimed to find the correlation between body mass index (BMI) and microalbuminuria (MA) in essential hypertensive adults. Methods: This study included 35 essential hypertensive patients in the 18–65 years of age group, who satisfied the inclusion criteria. Arterial blood pressure was measured by a sphygmomanometer and the first voided early morning urine sample was collected for the estimation of microalbumin. Results: The mean age of the population studied was 49±11.08 in essential hypertensive patients and 46.89±11.10 in the control group. The mean value of BMI in the hypertensive group was found to be 27.59±5.45. In the present study, the mean value of microalbumin in essential hypertensive patients was 20.95±16.96. A significant positive correlation between BMI and MA was observed in the study with p<0.001. Conclusion: Our study shows a positive correlation between BMI and MA. Therefore, this study will help in the early detection of renal injury and prevents its progression to renal failure by lifestyle and diet modifications.

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Uterine Myoma: A Profile of Nepalese women

Nepal Journal of Obstetrics and Gynaecology ◽

10.3126/njog.v1i2.2397 ◽

1970 ◽

Vol 1 (2) ◽

pp. 47-50

Author(s):

Pramila Pradhan ◽

Nitish Acharya ◽

Binit Kharel ◽

Manoj Manjin

Keyword(s):

Abdominal Mass ◽

College Teaching ◽

Total Abdominal Hysterectomy ◽

Abdominal Hysterectomy ◽

Early Marriage ◽

Early Completion ◽

Medical College ◽

Underlying Risk Factor ◽

The Mean ◽

Myoma Uteri

Objectives: To determine the most common age and parity for the development of myoma uteri. To find out any relation between age of the last child and the development of myoma uteri. To determine the treatment protocal and outcome of treatment. Materials/methods: This study was carried out at Nepal Medical College Teaching Hospital from Jan 2001 to 31st June 2006. All cases of myoma uteri admitted in Gynaecological ward was included.. Histological evidence of myoma confirmed the diagnosis. Age, parity and age of the last child, clinical features, surgical procedures and outcome of surgery were considered. Results: A total of 137 cases of myoma uteri was operated during five and half years period. This represented 38.5 %of all abdominal hysterectomy performed during the same period. The mean age was 43.3 years with median parity at 1-3 and the mean age of last child at 12years. Excessive menstrual bleeding 73.0%, abdominal mass and pain 58.4%, dysmenorrhea 18.2% and infertility 7.3% were the common symptoms. Total abdominal hysterectomy was the mainstay of treatment. Patients were happy with the treatment specially those with severe and multiple symptoms Postoperative complications were not significant. There was one death due to pulmonary embolism who had mesothelioma of pleura diagnosed by pleural biopsy before operation. Conclusion: Early marriage and early completion of the family is the social trend in Nepalese society. Myoma is common in 4th-5th decade of life in multi parity with the age of last child around 12years. This long standing secondary infertility may be an underlying risk factor in the development of myoma uteri. doi:10.3126/njog.v1i2.2397 N. J. Obstet. Gynaecol Vol. 1, No. 2, p. 47-50 Nov-Dec 2006

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Recurrence patterns in patients with stage IIIC1 versus IIIC2 endometrial adenocarcinoma.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e15501 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e15501-e15501

Author(s):

Catherine Bevan ◽

Christa Irene Nagel ◽

Todd Patrtick Boren ◽

David Scott Miller ◽

Siobhan Marie Kehoe ◽

...

Keyword(s):

Endometrial Cancer ◽

Endometrial Adenocarcinoma ◽

Total Abdominal Hysterectomy ◽

Abdominal Hysterectomy ◽

Distant Recurrence ◽

Exact Test ◽

Frontline Treatment ◽

Recurrence Patterns ◽

The Mean ◽

To Receive

e15501 Background: To identify differences in recurrence patterns between stage IIIC1 and IIIC2 endometrial adenocarcinomas. Methods: A retrospective review was performed with IRB approval of all patients treated for stage IIIC1 and IIIC2 endometrial adenocarcinoma at our institution from 1989-2011. Patients were required to have comprehensive surgical staging including total abdominal hysterectomy, bilateral salpingo-ophorectomy, pelvic and paraaortic lymph node dissection. Descriptive statistics were performed using Microsoft Excel 2011 and Fischer’s exact test, Kaplan-Meier analyses were used to compare disease free (DFS) and overall survival (OS). Results: Eighty-seven patients with stage IIIC endometrial adenocarcinoma were identified, of which 69 were evaluable. The mean age was 59 years and the mean follow up was 32 months. There were 31 patients with stage IIIC1 and 38 patients with stage IIIC2 disease. There was no statistical difference in histology between the two groups: 47 endometrioid, 11 papillary serous, and 11 with other types of adenocarcinoma. Patients with stage IIIC1 disease were more likely to receive pelvic radiation (p=0.0004) and patients with IIIC2 disease were more likely to receive chemotherapy (p=0.014). Median DFS was 28.9 months (range 0-112) and 15.0 months (range 0-166) (p=0.017) and median OS was 31.9 months (range 0-134) and 18.0 months (range 0-166) (p=0.061) for the IIIC1 and IIIC2 groups respectively. Seven of 31 (23%) patients with stage IIIC1 disease recurred: 1 (14%) at the vaginal cuff and 6 (86%) distant. The patient who recurred locally was initially treated with chemotherapy alone. Of the 6 patients with distant recurrences only 1 received chemotherapy. Twelve of the 38 (32%) patients with stage IIIC2 experienced a recurrence: 6 (50%) vaginal/pelvic and 6 (50%) distant. There was a difference between the rates of local versus distant recurrence in patients with IIIC1 and IIIC2 endometrial cancer. Conclusions: IIIC1 patients were less likely to receive systemic chemotherapy and more likely to recur distantly. Our findings suggest a role for adjuvant chemotherapy and radiation in the frontline treatment of both IIIC1 and IIIC2 endometrial cancer.

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Xenon Provides Faster Emergence from Anesthesia than Does Nitrous Oxide-sevoflurane or Nitrous Oxide-isoflurane

Anesthesiology ◽

10.1097/00000542-199706000-00007 ◽

1997 ◽

Vol 86 (6) ◽

pp. 1273-1278 ◽

Cited By ~ 67

Author(s):

Takahisa Goto ◽

Hayato Saito ◽

Masahiro Shinkai ◽

Yoshinori Nakata ◽

Fumito Ichinose ◽

...

Keyword(s):

Nitrous Oxide ◽

Minimum Alveolar Concentration ◽

Total Abdominal Hysterectomy ◽

Abdominal Hysterectomy ◽

Patient Demographics ◽

The Mean ◽

American Society ◽

End Tidal ◽

To Receive ◽

Rapid Emergence

Background Xenon, an inert gas with anesthetic properties (minimum alveolar concentration [MAC] = 71%), has an extremely low blood:gas partition coefficient (0.14). Therefore, we predicted that xenon would provide more rapid emergence from anesthesia than does N2O+isoflurane or N2O+sevoflurane of equivalent MAC. Methods Thirty American Society of Anesthsiologists class I or II patients undergoing total abdominal hysterectomy were randomly assigned to receive 60% xenon, 60% N2O + 0.5% isoflurane, or 60% N2O + 0.70% sevoflurane (all concentrations are end-tidal: n = 10 per group). After placement of an epidural catheter, anesthesia was induced with standardized doses of midazolam, thiopental, and fentanyl. Thirty minutes later, xenon, N2O+isoflurane, or N2O+sevoflurane was started as previously assigned. These regimens were supplemented with epidural anesthesia with mepivacaine so that the mean arterial pressure and heart rate were controlled within 20% of the preoperative values. At the end of operation lasting approximately 2 h, all inhalational anesthetics were discontinued, and the patients were allowed to awaken while breathing spontaneously on an 8 l/min inflow of oxygen. A blinded investigator recorded the time until the patient opened her eyes on command (T1), was judged ready for extubation (T2), could correctly state her name, her date of birth, and the name of the hospital (T3), and could count backward from 10 to 1 in less than 15 s (T4). Results Emergence times from xenon anesthesia were: T1, 3.4 +/- 0.9 min; T2, 3.6 +/- 1 min; T3, 5.2 +/- 1.4 min; and T4, 6.0 +/- 1.6 min (mean +/- SD). These were one half to one third of those from N2O+sevoflurane (T1, 6.0 +/- 1.7 min; T4, 10.5 +/- 2.5 min) or N2O+isoflurane (T1, 7.0 +/- 1.9 min; T4, 14.3 +/- 2.8 min) anesthesia. The three groups did not differ in terms of patient demographics, the duration of anesthesia, the amount of epidural mepivacaine administered, or the postoperative pain rating. No patient could recalls intraoperative events. Conclusions Emergence from xenon anesthesia is two or three times faster than that from equal-MAC N2O+isoflurane or N2O+sevoflurane anesthesia.

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Role of Preoperative Pregabalin in Reducing Inhalational Anaesthetic Requirements in Abdominal Hysterectomy: Randomized Controlled Trial

10.21203/rs.2.183/v1 ◽

2019 ◽

Author(s):

Ahmed Abdalla Mohamed ◽

Gehan Helmy Ibrahim ◽

Nesrine Abd Elrahman El Refai ◽

Tamer Mousaad Abdelhamid Gamaleldin ◽

Reham Ali Abdelrahman Abdelrahman ◽

...

Keyword(s):

Postoperative Pain ◽

General Anaesthesia ◽

Bispectral Index ◽

Total Abdominal Hysterectomy ◽

Abdominal Hysterectomy ◽

Neurological Dysfunction ◽

Hypoglycemic Agents ◽

Controlled Study ◽

Control Group ◽

Rescue Analgesia

Abstract Background: preoperative oral pregabalin controls postoperative pain & decreases anesthetic requirements in total intravenous anaesthesia . In this study, we hypothesized that preoperative pregabalin reduces inhaled isoflurane requirements. Methods: Study was conducted in a university hospital, included 50 women (18-60 yrs.), ASA I or II, admitted to undergo elective abdominal hysterectomy under general anaesthesia. Time of study: June to September 2017. Exclusion criteria were allergy or hypersensitivity to pregabalin; patients on calcium channel blockers, antiepileptic drugs, antidepression drugs, any analgesics or sedatives, or oral hypoglycemic agents; and patients with severe cardiovascular, renal, hepatic or neurological dysfunction. Interventions: giving either oral pregabalin 150 mg or placebo to patients of both groups. Primary outcome measures: inhaled isoflurane requirements to maintain haemodynamics ± 20% of baseline& bispectral index (BIS) of 40 - 60, measured using MAQUET Flow-I anaesthetic machine. Secondary outcomes : attenuation of pressor response to intubation, postoperative pain, first time for rescue analgesia, total anaglesics and adverse effects. Results: Isoflurane consumption was significantly less in pregabalin group (7.80 ± 1.27ml h -1) versus (12.27 ± 2.49 ml h-1) in control group, (P= 0.00). Better haemodynamic stability was in pregabalin group after intubation. First postoperative hour :the mean VAS score was significantly higher in control group (7.10 ± 1.20) compared to pregabalin group (4.50 ± 1.70), P<0.001. All patients in control group received pethidine intramuscular. More patients in pregabalin group suffered dizziness. Conclusion: preoperative pregabalin 150 mg ,1 h before total abdominal hysterectomy has an inhaled anaesthetic-sparing effect, maintain haemodynamics and optimizes postoperative analgesia. Keywords: Gabapentinoids, Pregabalin; Inhalation Anaesthetics, Isoflurane; Monitoring, Bispectral Index; Surgery, Abdominal Hysterectomy Objectives: We aimed to investigate the effectiveness and safety of preoperative oral pregabalin 150 mg in women undergoing elective total abdominal hysterectomy under general anaesthesia. Design: A prospective, randomized, double-blind, controlled study. Trial Registry Number: ClinicalTrials.gov: NCT 03302208

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