scholarly journals Effect of Low-Dose Dexmedetomidine on the Anesthetic and Recovery Profile of Sevoflurane-Based Anesthesia in Patients Presenting for Supratentorial Neurosurgeries: A Randomized Double-Blind Placebo-Controlled Trial

2020 ◽  
Vol 11 (02) ◽  
pp. 267-273
Author(s):  
Unnikrishnan Prathapadas ◽  
Ajay Prasad Hrishi ◽  
Arulvelan Appavoo ◽  
Smita Vimala ◽  
Manikandan Sethuraman

Abstract Background Dexmedetomidine could be a suitable adjuvant in neuroanesthesia due to its analgesic and anesthetic-sparing properties with the added advantage of facilitating intraoperative neuromonitoring. However, its recovery profile is still debated upon, as in neuroanesthesia, a prompt recovery is essential for postoperative neurologic assessment. We designed this study to evaluate the effect of dexmedetomidine on the anesthetic and recovery profile of patients presenting for supratentorial neurosurgeries. Materials and Methods Forty adult patients undergoing supratentorial surgeries were recruited in this prospective, randomized, double-blinded study and were divided into two groups: group S and group SD. Both groups received sevoflurane and fentanyl for maintenance, whereas group SD alone received a low dose of dexmedetomidine infusion. Recovery parameters, opioid consumption, Richmond Agitation–Sedation Scale (RASS) and visual analogue scale (VAS) scores, incidence of nausea and vomiting, and intraoperative hemodynamics were analyzed. Results  There were no statistically significant differences between the groups S and SD in case of recovery parameters—time taken (in minutes, presented as median with interquartile range [IQR]) for (1) eye-opening to command: 9.5 (8–18) versus 22.5 (5–47.5) (p = 0.414); 2) following verbal command: 10.5 (8.25–29.5) versus 25 (10–28.75) (p = 0.512); (3) extubation: 11 (9.25–22) versus 25 (10–30) (p = 0.277); and (4) getting oriented to place, time, and date: 23 (20–52.75) versus 27.5 (25–36.5) (p = 0.121). Fentanyl consumption was significantly less in group SD (451 ± 39.3) versus group S (524.3 ± 144.1) (p = 0.034). The median RASS score with IQR and the median VAS scores with IQR were comparable between the groups at all time points. Of the 20 patients in group S, 5 had complaints of nausea and vomiting compared with none in the group SD, although it was not statistically significant. The hemodynamic parameters did not show a significant difference between the groups except for a surge in mean arterial pressure at 30 minutes in group S. Conclusion Low-dose dexmedetomidine as an adjuvant to sevoflurane- and fentanyl-based anesthesia could provide stable hemodynamics and lesser anesthetics and opioid consumption, without adversely affecting the recovery profile in patients undergoing supratentorial neurosurgical procedures.

Pain Medicine ◽  
2019 ◽  
Vol 20 (12) ◽  
pp. 2528-2538
Author(s):  
John R Zuniga ◽  
Athena S Papas ◽  
Stephen E Daniels ◽  
Kyle Patrick ◽  
Derek D Muse ◽  
...  

Abstract Objectives To evaluate the prevention of opioid-induced nausea and vomiting (OINV) and the relief of moderate to severe acute pain by CL-108, a novel drug combining a low-dose antiemetic (rapid-release promethazine 12.5 mg) with hydrocodone 7.5 mg/acetaminophen 325 mg (HC/APAP) was used. Methods This was a multicenter, randomized, double-blind, placebo- and active-controlled multidose study. After surgical extraction of two or more impacted third molar teeth (including at least one mandibular impaction), 466 patients with moderate to severe pain (measured on a categorical pain intensity scale [PI-CAT]) were randomized to CL-108, HC/APAP, or placebo. Over the next 24 hours, patients used the PI-CAT to assess pain at regular intervals whereas nausea, vomiting, and other opioid-related side effects were also assessed prospectively. Study medications were taken every four to six hours as needed; supplemental rescue analgesic and antiemetic medications were permitted. Co-primary end points were the incidence of OINV and the time-weighted sum of pain intensity differences over 24 hours (SPID24). Results Relative to HC/APAP treatment alone, CL-108 treatment reduced OINV by 64% (P < 0.001). Treatment with CL-108 significantly reduced pain intensity compared with placebo (SPID24 = 16.2 vs 3.5, P < 0.001). There were no unexpected or serious adverse events. Conclusions CL-108 is a safe and effective combination analgesic/antiemetic for the prevention of OINV during treatment of moderate to severe acute pain.


2018 ◽  
Vol 1 (1) ◽  
pp. 42
Author(s):  
Perjuangan Dapot Hamonangan Simbolon ◽  
Selvi Nafianti ◽  
Pertin Sianturi ◽  
Bidasari Lubis ◽  
Aznan Lelo

Background Chemotherapy-induced nausea and vomiting are some of the most disturbing side effects in pediatric cancer patients. The standard recommendation is the use of 5-hydroxytryptamine 3 receptor antagonist, such as ondansetron, to treat these symptoms. Despite this treatment, more than 50% of patients still experience nausea and vomiting.Objective To evaluate the effect of the addition of omeprazole to ondansetron in the treatment of chemotherapy-induced nausea and vomiting.Methods A double-blind, randomized, controlled trial was conducted at Haji Adam Malik Hospital, Medan, North Sumatera, from March to May 2016. Subjects were children aged 1 to 18 years, diagnosed with cancer, and who received intravenous chemotherapy. Patients were randomized to receive either a single dose of ondansetron (0.5 mg/kg) plus placebo or ondansetron (0.5 mg/kg) plus omeprazole (0.5 mg/kg). The severity of nausea and vomiting were measured using the Rhodes index of nausea, vomiting, and retching during the 24 hours after initiation of emetogenic chemotherapy. The primary outcome of efficacy was the proportion of patients who achieved complete response (lack of nausea/vomiting). Statistical analysis was performed by Chi-square and Fischer’s exact tests.Results Seventy eligible pediatric patients were randomized into two groups: 32 subjects in the ondansetron + placebo group and 38 others in the ondansetron + omeprazole group. The therapy failed in 50% (16/32) of the ondansetron + placebo group and 18.4% (7/38) of the ondansetron + omeprazole group. There was a significant difference in the clinical response between groups (P=0.01).Conclusion The addition of omeprazole to ondansetron for the treatment of chemotherapy-induced nausea and vomiting is more effective than administration of ondansetron alone.


Author(s):  
Nilufer Akgun ◽  
Esra Keskin ◽  
Muberra Namlı Kalem ◽  
Batuhan Bakirarar

Background: Safe, effective, long term and a reversible contraception method is offered by intrauterine devices (IUDs).  The objective was to determine the potency of intrauterine administration of 5 cc levobupivacain for pain relief with IUD insertion, when compared with saline placebo.Methods: This was a prospective randomized, double blind placebo-controlled trial undergoing İUD insertion. The trial medication was intrauterine anesthesia, either 5 mL 0.9% saline (control group), or 5 mL 0.5% levobupivacaine. Our primary outcome was self-reported pain scores on a 10 cm visual analogue scale (VAS) immediately following IUD insertion.Results: 95 women were enrolled, and data for 88 women were analyzed. In IUD insertion procedure, no difference was observed between groups during teneculum placement and solution administration, in the course of VAS scores (p=0.349, p=0.396). There was a significant difference in the VAS scores measuring pain suffering during and after IUD procedure (p=0.001).Conclusions: Intrauterine instillation of 5 cc of levobupivacaine along with saline solution reduces pain with IUD insertion when compared to intrauterine saline placebo. Broad deviation in pain scores and persistent pain after IUD insertion recommends that patient would benefit from more functioning method of pain control than before at IUD insertion and during the post interval.


2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Mine Celik ◽  
Aysenur Dostbil ◽  
Mehmet Aksoy ◽  
Ilker Ince ◽  
Ali Ahiskalioglu ◽  
...  

Background. Postoperative nausea and vomiting (PONV) is one of common complications in patients undergoing laparoscopic cholecystectomy (LC). Aim of this study was to compare the efficacy of subhypnotic (1 mg/kg/h) infusion of propofol with dexamethasone on PONV in patients undergoing LC.Methods. A total of 120 patients were included in this randomized, double-blind, placebo-controlled study. Patients were randomly assigned to 3 groups; patients of group dexamethasone (group D) were administrated 8 mg dexamethasone before induction of anesthesia, patients of group propofol (group P) were infused to subhypnotic (1 mg/kg/h) propofol during operation and patients of group control (group C) were applied infusion of 10% intralipid. The incidence of PONV and needs for rescue analgesic and antiemetic were recorded in the first 24 h postoperatively.Results. In the 0–24 h, the incidence of PONV was significantly lower in the group D and group P compared with the group C (37.5%, 40%, and 72.5%, resp.). There was no significant difference in the incidence of PONV and use of antiemetics and analgesic between group D and group P.Conclusion. We concluded that infusion of propofol 1 mg/kg/h is as effective as dexamethasone for the prevention of PONV during the first 24 hours after anesthesia in patients undergoing LC.


2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Jeong-Su Park ◽  
Sunju Park ◽  
Chun-Hoo Cheon ◽  
Seong-Cheon Jo ◽  
Han Baek Cho ◽  
...  

Objective. This study was a multicenter, randomized, double-blind, and controlled trial with two parallel arms: the GJBNH group and the placebo group. This trial recruited 100 women aging 18 to 35 years with primary dysmenorrhea caused by blood stagnation. The investigational drugs, GJBNH or placebo, were administered for two menstrual periods (8 weeks) to the participants three times per day. The participants were followed up for two menstrual cycles after the administration.Results. The results were analyzed by the intention-to-treat (ITT) dataset and the per-protocol (PP) dataset. In the ITT dataset, the change of the average menstrual pain VAS score in the GJBNH group was statistically significantly lower than that in the control group. Significant difference was not observed in the SF-MPQ score change between the GJBNH group and the placebo group. No significant difference was observed in the PP analyses. In the follow-up phase, the VAS scores of the average menstrual pain and the maximum menstrual pain continually decreased in the placebo group, but they increased in the GJBNH group.Conclusion. GJBNH treatment for eight weeks improved the pain of the dysmenorrhea caused by blood stagnation, but it should be successively administered for more than two menstrual cycles.Trial Registration. This trial is registered with Current Controlled Trials no.ISRCTN30426947.


2019 ◽  
Vol 7 (1) ◽  
pp. 25-32
Author(s):  
Arna Fransisca ◽  
Iwan Fuadi ◽  
Dewi Yulianti Bisri

Mual muntah pascaoperasi merupakan salah satu komplikasi anestesi dan operasi yang menjadi perhatian khusus karena memengaruhi kualitas pelayanan kesehatan, memperpanjang lama perawatan, dan meningkatkan angka morbiditas perioperatif. Pascaoperasi payudara berkaitan dengan angka kejadian mual muntah pascaoperasi yang tinggi. Beberapa konsensus penatalaksanaan mual muntah pascaoperasi merekomendasikan pemberian terapi nonfarmakologi dengan aromaterapi sebagai terapi rescue untuk mengatasi mual muntah pascaoperasi. Tujuan penelitian ini adalah membandingkan aromaterapi pepermin dengan ondansetron sebagai terapi rescue dalam menurunkan kejadian mual muntah pascaoperasi mastektomi. Penelitian ini merupakan penelitian eksperimental yang dilakukan secara prospektif dengan desain penelitian double blind randomized controlled trial dan consecutive sampling terhadap 32 subjek penelitian yang menjalani operasi mastektomi elektif dan memenuhi kriteria inklusi di RSUP Dr. Hasan Sadikin Bandung pada bulan Juli–September 2018. Pada penelitian ini, data ordinal diuji dengan Uji Mann Whitney dan untuk data kategorik diuji dengan uji chi-square. Hasil penelitian ini didapatkan penurunan kejadian mual muntah pascaoperasi yang signifikan pada kelompok pepermin dibanding dengan kelompok ondansetron dengan perbedaan yang bermakna (p<0,05) pada penilaian menit kedua dan menit kelima setelah perlakuan. Simpulan, aromaterapi pepermin efektif menurunkan kejadian mual muntah pascaoperasi mastektomi dan dapat digunakan sebagai alternatif terapi atau terapi tambahan untuk penatalaksanaan mual muntah pascaoperasi.Comparison of Peppermint Aromatherapy with Ondansetron Intravenous as a Rescue for Postoperative Nausea Vomiting after Mastectomy SurgeryPostoperative nausea and vomiting are among anesthesia and surgery  complications that receive special considerations as it affects the quality of healthcare services, prolongs care, and increases perioperative morbidities. The incidence of postoperative nausea and vomiting is high in patients that have undergone breast surgery. The consensus for postoperative nausea and vomiting management recommends non-pharmacological treatments, one of which is through the use of aromatherapy as a rescue to resolve postoperative nausea and vomiting. This study aimed to compare the effects of peppermint aromatherapy and ondansetron as a rescue in reducing the incidence of postoperative nausea and vomiting after elective mastectomies. This was a prospective experimental double blind randomized controlled trial study with consecutive sampling on 32 research subjects underwent elective mastectomies and met the inclusion criteria in Dr. Hasan Sadikin General Hospital in July–September 2018. The ordinal data were tested using the Mann Whitney statistics test and the categorical data using the chi square test. The results show a significant decrease in nausea and vomiting incidence in the peppermint group compared to the ondansetron group with significant difference (p<0.05) in two minutes and five minutes after treatment. In conclusion, peppermint aromatherapy is effective in reducing the incidence of postoperative nausea and vomiting after mastectomies and can be used as an alternative or additional treatment in managing postoperative nausea and vomiting.


2020 ◽  
pp. 2003338
Author(s):  
Christine R. Jenkins ◽  
Fu-Qiang Wen ◽  
Allison Martin ◽  
Peter J. Barnes ◽  
Bartolome Celli ◽  
...  

BackgroundThe highest burden of Chronic Obstructive Pulmonary Disease (COPD) occurs in low and middle income countries. Low cost oral medications, if effective, could enable affordable, accessible COPD treatment.MethodsIn this randomised, 3 arm, double-blind, double dummy, placebo controlled study conducted in 37 centres in China, symptomatic patients with moderate/very severe COPD were randomised 1:1:1 to low dose (LD) theophylline 100 mg bd+prednisone 5 mg once daily; LD theophylline 100 mg bd+placebo once daily; or placebo bd+placebo once daily for 48 weeks. The primary endpoint was annualised exacerbation rate.Findings1670 subjects were randomised, and 1242 completed the study (1142 with acceptable Week 48 data). Subjects (75.7% male) were mean age 64.4 years, with mean (sd) baseline post-bronchodilator Forced Expiratory Volume in 1 s (FEV1) 1.1 (0.4)L, 42.2% predicted and mean (sd) St Georges Respiratory Questionnaire (SGRQ) score 45.8 (20.1). There were negligible differences between annualised exacerbation rates across the three treatments, being 0.89 (95%CI=0.78–1.02) on Prednisone-LD Theophylline; 0.86 (0.75–0.99) on LD Theophylline plus placebo, and 1.00 (0.87–1.14) on double placebo. The Rate Ratio between the first and the pooled comparative arms was 0.96 (0.83–1.12), and for LD Theophylline+placebo versus placebo was 0.866, 95% CI 0.728; 1.029, p=0.101 and for LD Theophylline+Low dose oral Prednisone versus placebo was 0.895, 95% CI 0.755; 1.061, p=0.201. Secondary outcomes of hospitalisations, FEV1, SGRQ and COPD Assessment Test (CAT) score showed no statistically significant difference between treatment arms. Serious adverse events (SAEs) other than exacerbations were <2% and did not differ between the treatment arms.ConclusionsLD theophylline alone or in combination with prednisone did not reduce exacerbation rates or clinically important secondary endpoints compared to placebo.


2018 ◽  
Vol 58 (1) ◽  
pp. 42
Author(s):  
Perjuangan Dapot Hamonangan Simbolon ◽  
Selvi Nafianti ◽  
Pertin Sianturi ◽  
Bidasari Lubis ◽  
Aznan Lelo

Background Chemotherapy-induced nausea and vomiting are some of the most disturbing side effects in pediatric cancer patients. The standard recommendation is the use of 5-hydroxytryptamine 3 receptor antagonist, such as ondansetron, to treat these symptoms. Despite this treatment, more than 50% of patients still experience nausea and vomiting.Objective To evaluate the effect of the addition of omeprazole to ondansetron in the treatment of chemotherapy-induced nausea and vomiting.Methods A double-blind, randomized, controlled trial was conducted at Haji Adam Malik Hospital, Medan, North Sumatera, from March to May 2016. Subjects were children aged 1 to 18 years, diagnosed with cancer, and who received intravenous chemotherapy. Patients were randomized to receive either a single dose of ondansetron (0.5 mg/kg) plus placebo or ondansetron (0.5 mg/kg) plus omeprazole (0.5 mg/kg). The severity of nausea and vomiting were measured using the Rhodes index of nausea, vomiting, and retching during the 24 hours after initiation of emetogenic chemotherapy. The primary outcome of efficacy was the proportion of patients who achieved complete response (lack of nausea/vomiting). Statistical analysis was performed by Chi-square and Fischer’s exact tests.Results Seventy eligible pediatric patients were randomized into two groups: 32 subjects in the ondansetron + placebo group and 38 others in the ondansetron + omeprazole group. The therapy failed in 50% (16/32) of the ondansetron + placebo group and 18.4% (7/38) of the ondansetron + omeprazole group. There was a significant difference in the clinical response between groups (P=0.01).Conclusion The addition of omeprazole to ondansetron for the treatment of chemotherapy-induced nausea and vomiting is more effective than administration of ondansetron alone.


2018 ◽  
Vol 17 (3) ◽  
pp. 747-754 ◽  
Author(s):  
Xiangfeng Li ◽  
Ying Qin ◽  
Wei Liu ◽  
Xiao-yu Zhou ◽  
Ya-nan Li ◽  
...  

Nausea and vomiting are among the most common and distressing side effects of chemotherapy. Additional antiemetic drugs are urgently needed to effectively manage and ameliorate chemotherapy-induced nausea and vomiting (CINV). The efficacy of ginger as an antiemetic modality for ameliorating CINV has not been established in previous studies. The aim of this study was to examine the efficacy of ginger, as an adjuvant drug to standard antiemetic therapy, in ameliorating acute and delayed CINV in patients with lung cancer receiving cisplatin-based regimens. In this randomized, double-blind, placebo-controlled clinical trial, 140 patients with lung cancer receiving cisplatin-based regimens were enrolled and allocated to receive either ginger root powder or a placebo. Ginger root powder was administered orally (0.5 g, 2 capsules per day, 0.25 g per capsule, every 12 hours) for 5 days beginning on the first day of chemotherapy. The incidence and severity of acute and delayed nausea and vomiting were assessed using the MASCC (Multinational Association for Supportive Care in Cancer) Antiemesis Tool (MAT). Adverse effects and patient adherence were also assessed in this study. No significant difference was observed between the ginger and control groups in the reduction of the incidence and severity of nausea and vomiting ( P > .05). No significant difference in adverse events was observed between the 2 groups ( P > .05). No study-treatment-related adverse events were observed in this study. As an adjuvant drug to standard antiemetic therapy, ginger had no additional efficacy in ameliorating CINV in patients with lung cancer receiving cisplatin-based regimens.


Author(s):  
Afshin, Amini ◽  
Arash, Farbood ◽  
Seyed Masoud, Hashemi ◽  
Mehrdad, Taheri ◽  
Amin Reza, Khaledi ◽  
...  

Background: Femoral 3-in-1 block is one of the most effective methods in cases of hip nailing surgery because of its ease, low cost, and fewer complications. This study aims to evaluate the effect of adding dexamethasone to peripheral nerve block solution. Methods: Forty-four ASA (I,II & III) patients aged between 50-80 years, scheduled for elective hip-nailing surgery who met inclusion and exclusion criteria were enrolled in this double blind randomized controlled trial. Patients were allocated into two groups randomly; at the end of the surgery, femoral 3-in-1 nerve block was performed with 40 ml of bupivacaine 0.25% solution with or without 8 mg dexamethasone. Pain score was measured for 24 hours. Results: We found no significant difference in pain intensity scores until hour 0.5 and the scores were below 1. Thereafter, the VAS scores increased, yet it remained below 3 in the first 12 postoperative hours. Morphine was administered during hours 12-24 in both groups, when VAS scores reached to about 4. The total amount of morphine consumption was a little lower in the case group, although the difference was not statistically significant. Conclusion: Adding dexamethasone to bupivacaine 0.25% for 3-in-1 block has no more benefit than bupivacaine 0.25% alone for acute postoperative pain management after elective hip nailing surgery.


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