scholarly journals The Efficacy of Prophylactic Intravenous Granisetron in Preventing Post Anaesthesia Shivering in Gynaecological Patients Undergoing Surgery Under General Anaesthesia

2021 ◽  
Vol 16 (1) ◽  
pp. 20-29
Author(s):  
Joanna Ooi Su Min ◽  

Post-anaesthetic shivering is one of the commonest complications during emergence from general anaesthesia with the rate of occurrence between 5 to 65%. It increases oxygen consumption and carbon dioxide production resulting in delayed recovery from anaesthesia and other adverse events. Granisetron is one of the drugs used to prevent post-anaesthetic shivering. This prospective, double-blind and randomised control study compared the efficacy of prophylaxis IV granisetron at 2 mg and 3 mg doses in preventing post-anaesthetic shivering. There were 104 patients, ASA I and II scheduled for elective open gynaecological surgery recruited and randomised into 2 groups: Group A and B, receiving 2 and 3 mg of IV granisetron, resepectively. Intravenous anaesthetic drugs were administered and tracheal intubation was facilitated by muscle paralysis. Patients’ baseline and periodic tympanic core temperatures were measured perioperatively. The incidence and severity of shivering were assessed postoperatively using Wrench Scoring Classification whereby Group A and B had 8.3% and 16.7% of incidence, respectively, in which they were not statistically significant (p = 0.199). All patients from both groups who shivered experienced Grade 1 shivering except for one patient who registered a Grade 2 in Group B. None of our patients had Grade 3 or 4 shivering postoperatively. No one experienced nausea or vomiting in the recovery area. Prophylactic IV granisetron of 2 mg and 3 mg were equally effective in reducing the incidence and severity of post-anaesthetic shivering in gynaecological patients undergoing surgery under general anaesthesia with no unpleasant side effects.

2020 ◽  
Vol 11 (3) ◽  
pp. 3418-3423
Author(s):  
Sweety Agrawal ◽  
Shubdha Bhagat ◽  
Pratibha Deshmukh ◽  
Amol Singham

The present study was done to evaluate the ability of oral pregabalin to attenuate the pressor response to airway instrumentation in patients undergoing laparoscopic cholecystectomy under general anesthesia. Sixty-four adult patients aged between 25-55 year of either gender belonging to ASA-1 or ASA2 physical status weighing 50-70 kg were enrolled in this study. Thirty-two patients each were randomized to group A, or group B. Patients in group A received tablet Pregabalin (150mg) and those in group B received placebo orally one hour before induction of anaesthesia. Heart rate, blood pressure, and sedation were assessed preoperatively before giving the tablets and after 30 minutes, and just before induction of anaesthesia. Intraoperative, pulse rate, mean arterial pressure, ECG in the lead II, SPO2 and ETCO2 were monitored. All the above parameters were noted during laryngoscopy and intubation, 3 minutes after CO2 insufflation, and then at every 10-minute interval till the end of surgery. These parameters were also recorded after extubating the patient. The Ramsay sedation scale was used to assess the sedation at the baseline, one hour after drug intake , one hour after extubation and 4 hour after surgery. Any adverse effects in the postoperative period were recorded. The result of our study shows that pre-emptive administration of oral pregabalin 150 mg significantly reduced the pressor response at the time of laryngoscopy and intubation, after CO2 insufflation and just after extubation. We conclude that oral pregabalin premedication is effective in successful attenuation of hemodynamic pressor response to laryngoscopy, intubation and pneumoperitoneum in patients undergoing laparoscopic cholecystectomy


2020 ◽  
Author(s):  
Lungwani Muungo

Objectives: Self-administered vaginal rings are a promising method for delivery of topical anti-HIV microbicidesand might offer an adherence advantage over daily or coitally-dependent dosage forms such as gels. This trialassessed the safety and pharmacokinetic aspects of the Dapivirine Vaginal Ring-004 when worn as multiple rings oversequential periods of ring use by healthy, sexually-active, HIV-negative women.Methods: This double-blind trial was conducted among 48 women (18-40 years). Participants were randomlyassigned to two groups (A or B) and received (3:1) either the dapivirine or a placebo vaginal ring. Group A used tworings over a 56-day period and Group B used three rings over a 57-day period. Safety evaluations were conductedthroughout the trial. Dapivirine concentrations were measured in plasma, vaginal fluid and cervical tissue samplescollected during and after the 56 days (Group A) or 57 days (Group B) of vaginal ring use.Results: Ring-004 was safe and well tolerated in all participants. The pharmacokinetic profile demonstrated arapid increase in plasma and vaginal fluid concentrations and achieved concentrations in vaginal fluids and cervicaltissue well above the in vitro IC99 in cervical tissue (3.3 ng/mL) that were sustained for a 28 to 35-day ring use period(approximately 3000 times higher in vaginal fluids and 14 -1000 times higher in cervical tissue). Drug levels wereassociated with significant inhibitory activity of genital secretions against HIV ex vivo, a biomarker of pharmacodynamics.Individual plasma dapivirine concentrations did not exceed 553 pg/mL and were well below plasma concentrations atthe maximum tolerated dose for oral treatment (mean Cmax 2286 ng/mL).Conclusions: The consecutive use of several rings over a period of up to 57 days was safe and well tolerated, andPK data indicate that a single Ring-004 is likely to be protective for at least 35 days.


2020 ◽  
Vol 15 ◽  
Author(s):  
Arash karimi ◽  
Jahanbakhsh Nejadi ◽  
Mahnaz Shamseh ◽  
Nooshin Ronasi ◽  
Mehdi Birjandi

Background: Postoperative nausea and vomiting (PONV) is a common complication associated with the use of anesthesia. Several antiemetics are used to reduce the incidence and severity of PONV. The aim of this study is to investigate the role of dexamethasone and ondansetron to treat PONV in patients undergoing cesarean section (c-section) under spinal anesthesia. Methods: This double-blind clinical trial study was performed on patients who were referred to the operating room of Haji Karim Asali Hospital of Khorramabad for elective cesarean section in 2016-17. Upon meeting the inclusion criteria, patients were allotted into two groups (n=60). Group A received 8mg of dexamethasone and group B received 4mg of ondansetron after spinal anesthesia. The Visual Analog Scale (VAS) questionnaire and Depression-Anxiety-Stress Scale (DASS) questionnaire was used for the analysis. Patients with mild to moderate stress, anxiety, and depression were included in the study. Data were analyzed using SPSS 16 software. Results: There was no difference in the demographic data of the two groups. The mean severity of nausea in group A was significantly higher than in group B. The frequency of vomiting in group A was 20 times higher than group B, which was found to be statistically significant, p = 0.018. Concerning the type of delivery with the frequency of nausea, the results showed that the frequency of nausea in group A was 3.24 times higher than group B, however, this difference was not statistically significant, p = 0.106. Conclusion: Based on the results of this study, ondansetron had a significant effect on the alleviation of postoperative nausea and vomiting, as compared to dexamethasone in c-section surgical candidates.


2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
E Durity ◽  
G Elliott ◽  
T Gana

Abstract Introduction Management of complicated diverticulitis has shifted towards a conservative approach over time. This study evaluates the feasibility and long-term outcomes of conservative management. Method We retrospectively evaluated a consecutive series of patients managed with perforated colonic diverticulitis from 2013-2017. Results Seventy-three (73) patients were included with a male to female ratio of 1:2. Thirty-one (31) underwent Hartmann’s procedure (Group A) and 42 patients were managed with antibiotics +/- radiological drainage (Group B). Mean follow-up was 64.9 months (range 3-7 years). CT Grade 3 and 4 disease was observed in 64.5% and 40.4% of Group A and Group B patients, respectively. During follow-up, 9 (21.4%) Group B patients required Hartmann’s. Group A had longer median length of stay compared to Group B (25.1 vs 9.2 days). Post-operative complications occurred in 80.6% with 40% being Clavien-Dindo grade III or higher in group A. Stoma reversal was performed in 8 patients (25.8%). Conclusions In carefully selected cases, complicated diverticulitis including CT grade 3 and 4 disease, can be managed conservatively with acceptable recurrence rates (16.7% at 30 days, 4.8% at 90 days, 19.0% at 5 years). Surgical intervention on the other hand, carries high post-operative complication rates and low stoma reversal rates.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11545-11545
Author(s):  
Daniel Pink ◽  
Dimosthenis Andreou ◽  
Anne Flörcken ◽  
Alexander Golf ◽  
Stephan Richter ◽  
...  

11545 Background: Single-agent PD-1 inhibitors have modest activity in the treatment of most STS. Potential strategies to increase efficacy include combination therapies targeting the tumor microenvironment. Considering that apart from direct growth inhibition and death of malignant cells, trabectedin (Tr) also induces macrophage depletion and/or different immunologic effects, suggesting a possible synergistic effect of combined Tr plus anti-PD-1 treatment. We therefore aimed to evaluate the efficacy and safety of combined Tr and nivolumab (Ni) as a second-line treatment in STS. Methods: The prospective, explorative, two group, non-randomized phase II NiTraSarc trial enrolled pretreated patients (pt) with advanced STS (Group A: lipo- or leiomyosarcomas, Group B: non-L-sarcomas). Pt were initially treated with 3 cycles of Tr 1.5 mg/m2, followed by the combination of Tr 1.5 mg/m2 + Ni 240 mg (“late combination cohort” (LCC)) for up to 16 cycles. After positive results of a preplanned interim analysis, pt received the combination therapy starting with cycle 2 (“early combination cohort” (ECC)). 92 pt were recruited to the trial (55 in Group A, 37 in Group B). Primary efficacy endpoint is progression-free survival rate after 6 months (PFSR6) according to RECIST v.1.1. This is a first analysis of the primary efficacy endpoint in Group B based on a modified intention-to-treat (mITT) population of evaluable 36 pt: 23 and 13 pt from the LCC and ECC, respectively. Results: The most common Group B subtypes comprised undifferentiated pleomorphic/not otherwise specified sarcoma (UPS/NOS, 13pt) and fibromyxoid sarcoma (FMS, 6pt). After a median follow-up of 5 months (m) PFSR6 was 13.9% for all pt, 8.7% in LCC and 23.1% in ECC. Median duration of disease stabilization (DoDS) was 4m in all pt, the LCC and the ECC. Two pt had a partial response (PR), 10 had disease stabilization (SD), while 13 pt progressed, and 11 had missing data. By subtype: PR- UPS/NOS=2 (DoDS 12.7m/12.5m). SD: UPS/NOS=3, epithelioid=2, synovial=2, FMS=1, fibrosarcoma=1, other=1. All 36 pt experienced at least one adverse event (AE) reaching a total of 579 AEs, 141 (24.4%) of which were considered to be grade ≥3 treatment-related AEs. The main grade ≥3 AEs were: leukopenia (47.2% of pt), neutropenia (41.7% of pt), thrombocytopenia (33.3% of pt), increased ALT (30.6% of pt), and anemia (27.8% of pt). Conclusions: Tr+Ni was well tolerated and showed activity in at least some patients with non-L-sarcomas (mostly UPS/NOS) especially in the ECC. Analyses of the collected data, including PD-L1 expression profile, with the goal to establish whether Tr+Ni should be further pursued in these patients, are ongoing. ClinicalTrials.gov Identifier: NCT03590210; EudraCT: 2017-001083-38. Clinical trial information: NCT03590210.


Author(s):  
Esmaeil Mohammadi ◽  
Sara Hanaei ◽  
Sina Azadnajafabad ◽  
Keyvan Tayebi Meybodi ◽  
Zohreh Habibi ◽  
...  

OBJECTIVE The role of tunneling an external ventricular drain (EVD) more than the standard 5 cm for controlling device-related infections remains controversial. METHODS This is a randomized, double-blind, 3-arm controlled trial done in the Children’s Medical Center in Tehran, Iran. Pediatric patients (< 18 years old) with temporary hydrocephalus requiring an EVD and no evidence of CSF infection or prior EVD insertion were enrolled. Patients were randomly assigned (1:1:1) into the following arms: 5-cm (standard; group A); 10-cm (group B); or 15-cm (group C) EVD tunnel lengths. The investigators, parents, and person performing the analysis were masked. The surgeon was informed of the length of the EVD by the monitoring board just before operation. Patients were followed until the EVD’s fate was established. Infection rate and other complications related to EVDs were assessed. RESULTS A total of 105 patients were enrolled in three random groups (group A = 36, group B = 35, and group C = 34). The EVD was removed because there was no further need in most cases (67.6%), followed by conversion to a new EVD or ventriculoperitoneal shunt (15.2%), infection (11.4%), and spontaneous discharge without further CSF diversion requirement (5.7%). No statistical difference was found in infection rate (p = 0.47) or EVD duration (p = 0.81) between the three groups. No group reached the efficacy point sooner than the standard group (group B: hazard ratio 1.21, 95% CI 0.75–1.94, p = 0.429; group C: hazard ratio 1.03, 95% CI 0.64–1.65, p = 0.91). CONCLUSIONS EVD tunnel lengths of 5 cm and longer did not show a difference in the infection rate in pediatric patients. Indeed, tunneling lengths of 5 cm and greater seem to be equally effective in preventing EVD infection. Clinical trial registration no.: IRCT20160430027680N2 (IRCT.ir)


2005 ◽  
Vol 90 (7) ◽  
pp. 4068-4074 ◽  
Author(s):  
Stefano Palomba ◽  
Francesco Orio ◽  
Angela Falbo ◽  
Francesco Manguso ◽  
Tiziana Russo ◽  
...  

Abstract Context: Although metformin has been shown to be effective in the treatment of anovulation in women with polycystic ovary syndrome (PCOS), clomiphene citrate (CC) is still considered to be the first-line drug to induce ovulation in these patients. Objective: The goal of this study was to compare the effectiveness of metformin and CC administration as a first-line treatment in anovulatory women with PCOS. Design: We describe a prospective parallel randomized, double-blind, double-dummy controlled clinical trial. Setting: The study was conducted at the University “Magna Graecia” of Catanzaro, Catanzaro, Italy. Patients: One hundred nonobese primary infertile anovulatory women with PCOS participated. Interventions: We administered metformin cloridrate (850 mg twice daily) plus placebo (group A) or placebo plus CC (150 mg for 5 d from the third day of a progesterone withdrawal bleeding) (group B) for 6 months each. Mean outcome measures: The main outcome measures were ovulation, pregnancy, abortion, and live-birth rates. Results: The subjects of groups A (n = 45) and B (n = 47) were studied for a total of 205 and 221 cycles, respectively. The ovulation rate was not statistically different between either treatment group (62.9 vs. 67.0%, P = 0.38), whereas the pregnancy rate was significantly higher in group A than group B (15.1 vs. 7.2%, P = 0.009). The difference found between groups A and B regarding the abortion rate was significant (9.7 vs. 37.5%, P = 0.045), whereas a positive trend was observed for the live-birth rate (83.9 vs. 56.3%, P = 0.07). The cumulative pregnancy rate was significantly higher in group A than group B (68.9 vs. 34.0%, P &lt; 0.001). Conclusions: Six-month metformin administration is significantly more effective than six-cycle CC treatment in improving fertility in anovulatory nonobese PCOS women.


Author(s):  
Dhanashree Dongare ◽  
Smita Gharde

Background: Dexmedetomidine is selective alpha 2 agonist with sedative sympatholytic, analgesic properties and is used as an anaesthetic adjuvant. We have evaluated the effect of dexmedetomidine on various hemodynamic responses to incidences such as laryngoscopy, endotracheal intubation, exubation and pneumoperitoneum in patients who were undergoing surgeries like laparoscopic cholecystectomy. We have used loading dose of 0.5mcg/kg of inj. Dexmedetomidine given over 10 minutes followed by infusion of a dose of 0.3mcg/kg/hour for the control of hemodynamic response to laparoscopy. Methods: Patient of either sex aged between 18-50 yrs, belongs to ASA I and II (AMERICAN SOCIETY OF ANAESTHESIOLOGY) posted for laparoscopic cholecystectomy were included. Institutional ethical committee clearance was obtained prior to study. After enrolment and valid written consent was taken. 60 patients were enrolled written valid informed consent was taken. Patients were divided into two groups 30 each with computerized randomization. Base line parameters were noted. Observer and patient was blinded for the content of syringe. Group A received injection dexmedetomidine and group B received bolus and infusion of normal saline at same rate. Routine general anaesthesia was instituted. Parameters were noted after induction, after intubation, after co2 insufflation, after 20 min, after 40 min, after co2 deflation, after extubation, after 1 and 2 hrs post-extubation. Results: Group A showed significantly less rise in HR and MAP than Group B. Requirement of intraoperative propofol was more in Group B. There was no significant difference for time taken to awakening in both groups. Conclusion: We found Injection Dexmedetomidine in given doses gave good hemodynamic control with minimal undesired effects during laparoscopy.


QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Waleed Mohamed Abd El Mageed ◽  
Ahmad Kamal Mohamed Ali ◽  
Eeman Aboubakr ElSiddik Ahmed Bayoumi ◽  
Haitham Sabry Mahmoud Omar

Abstract Background Various drugs are used for providing favorable intubation conditions during awake fiberoptic intubation (AFOI). However, most of them have various side effects. Aim The aim of this study was to compare the effects of dexmedetomedine and fentanyl as regards sedative effects, hemodynamic stability, intubation time and intubation attempts success during awake fiberoptic intubation. Material and Methods A randomized double-blind prospective study was conducted on a total of 40 patients scheduled for elective cervical spine surgeries who were randomly allocated into two equal groups (n 20): (group A) patients received a bolus dose of dexmedetomidine of 1 mcg/kg over 10 min followed by a continuous infusion of dexmedetomidine at 0.5 mcg/kg/h. and fentanyl group (group B) received dose of 1 μg/kg over 10 min followed by 0.5 μg/kg/hr. Sedation score (Ramsy sedation score), hemodynamic variables, oxygen saturation, intubation time and intubation attempts were noted and compared between the two groups. Results Ramsy Sedation Score was significantly favorable (P &lt; 0.001) in group A in comparison to group B, moreover better hemodynamic stability during intubation (P &lt; 0.05) and less intubation attempts were observed in group A in comparison to group B. Conclusion The results of our study showed that dexmedetomidine provides optimum sedation without compromising airway or hemodynamic stability and with favorable intubation time and less intubation attempts during AFOI in comparison to fentanyl.


2021 ◽  
Vol 8 (2) ◽  
pp. 321-325
Author(s):  
Dinesh Kumar Singh ◽  
B B Baj ◽  
Vipin Goyal

The aim of our study to determine the role of tolvaptan in prevention of hyponatremia in transurethral resection of prostate surgery. This is randomized double-blind study conducted in 60 ASA grade status 1 and 2 patients age group between 45-80 yrs undergoing TURP under spinal anaesthesia in urology operation theatre in Mahatma Gandhi hospital Jaipur after receiving permission from hospital ethical committee. A detailed history, complete physical examination and routine investigation were done for all patients followed by informed written consent was obtained. Patients are randomly divided into 2 groups. In group A -30 patients who received orally tab tolvaptan 15 mg and group B-30 patients who received orally tab multivitamin 2 hrs before surgery after doing electrolytes of the patients in the morning. In both groups age (in yrs), wt (in kg), ASA grade, volume of irrigating fluid (in litres), volume of prostate resected (in gm) and duration of surgery (in minutes) all demographic and surgical details data were compared. Electrolytes were compared in both groups pre and post-operatively and statistical analysis was done.There was significant difference in post-operative sodium level between the two groups (A and B). The mean level of sodium significantly reduced post-operatively in group –B (control grp). The mean level of sodium significantly increased post-operatively in group –A (tolvaptan grp). We conclude single dose of tolvaptan -15 mg found to effective in prevention of hyponatremia in patients undergoing TURP.


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