跳至主要内容
临床试验/NCT02803788
NCT02803788Unknown4 期

Comparative Study of Antiemetic Effect of Ramosetron With Combination of Ondansetron and Dexamethasone in Patients Undergoing Laparoscopic Cholecystectomy

Government Medical College, Haldwani1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
100
试验地点
1
主要终点
Comparison of antiemetic effect of Ramosetron with combination of Ondansetron and Dexamethasone in patients undergoing laparoscopic cholecystectomy

研究概览

简要总结

  • To study the efficacy and side effects of ondansetron with dexamethasone in patients undergoing standard laparoscopic cholecystectomy (control group).
  • To study the efficacy and side effects of ramosetron in patients undergoing standard laparoscopic cholecystectomy (study group).
  • To compare the efficacy and side effects of ondansetron with dexamethasone and ramosetron in patients undergoing standard laparoscopic cholecystectomy

详细描述

100 ASA Grade I/II young female patients of 20-40 years undergoing elective laparoscopic cholecystectomy will be equally divided into 2 groups (50 each): control group(Group 'O') and study group (Group 'R') using a computer generated sealed envelopes.

Control group patients will receive ondansetron with dexamethasone and the study group patients will receive ramosetron. Based on the previous studies advocating use of the minimum recommended doses, ramosetron in a dose of 0.3 mg and ondansetron in a dose of 4 mg and dexamethasone in a dose of 8mg will be administered for prevention of PONV in the present study. Medications will be prepared by a blinded paramedic not involved in the study in identical 5-ml syringes and will be administered according to the randomization list. Patients will be given tablet alprazolam(0.25 mg) orally on the night before surgery and advised nil per orally from midnight.

Inside operation theatre, patient NPO status and identity will be reassured. Intravenous line will be secured using 18 G IV cannula and intravenous fluid will be started. Standard non-invasive monitoring will be established intraoperatively using NIBP, HR, ECG, RR, SpO2 and will be continuous postoperatively. Patients will be premedicated with injection Glycopyrrolate (0.004mg/kg), injection Ranitidine (1mg/kg), injection metoclopramide (0.15mg/kg), injection butorphanol (0.04mg/kg). Patients will be induced with injection propofol 2 mg/ kg mixed with xylocard 2%(10mg of xylocard per 10ml propofol) and injection Succinylcholine 1.5 mg/kg and endotracheal intubation will be done. A nasogastric tube will be inserted after securing the endotracheal tube in place and confirming it with ETCO2 monitoring. Anesthesia will be maintained with nitrous oxide and halothane (0.4-1%) in oxygen. Intra-operative muscle relaxation was maintained with injection vecuronium.

At the end of the surgery, injection diclofenac 75 mg IM will be given before the reversal of neuromuscular blockade to pre-empt the post-operative pain and will be advised as IM injection twice a day for post operative analgesia. Additional post-operative analgesia will be provided with injection tramadol 2 mg/ kg slowly as and when required intravenously. Nasogastric suction will be done to remove any residual gastric contents. Residual effect of muscle relaxant will be reversed with injection neostigmine (0.04 mg/ kg) and injection glycopyrrolate (0.2mg for each 1.0 mg 0f neostigmine). Ondansetron (4 mg) with dexamethasone (8mg) or ramosetron (0.3 mg) will be administered intravenously before shifting of the patient from the operation theater to the post-anesthesia care unit (PACU) according to the group allocation. All port sites will be infiltrated with inj bupivacaine (0.25%).

In the post-operative period, patients will be monitored for nausea, vomiting, pain, vital signs, adverse effects and post-anesthetic discharge score for 48 h (every 4 hourly in first 24 hours and every 6 hourly in next 24 hours) and this will be recorded by an independent observer (usually a Resident Officer) who will be blinded to the study. Injection metoclopramide (10 mg I.V.) will be administered as an additional rescue antiemetic in patients with two or more than two episodes of vomiting and/or significant nausea at any time within 48 h of operation. Exact timing of the administration of the rescue antiemetic will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients of age group 20 - 40years undergoing elective laparoscopic cholecystectomy
  • ASA Physical Status- I & II

排除标准

  • • Negative consent
  • History of motion sickness
  • Pregnancy
  • Menstruating females
  • Antiemetic taken within 24 hours before surgery or any long term medication
  • History of any systemic diseases, cardio- respiratory, hepato-renal, neurological, endocrinal disorders, hematological disorders, drug or alcohol addiction, psychiatric diseases, study drug sensitivity, etc

研究组 & 干预措施

Group O

Active Comparator

this group will receive inj. ondansetron 4mg iv stat and inj. dexamethasone 8mg iv stat just before extubation.

干预措施: ramosetron, ondansetron, dexamethasone (Drug)

Group R

Experimental

this group will receive inj. ramosetron 0.3mg iv stat just before extubation.

干预措施: ramosetron, ondansetron, dexamethasone (Drug)

结局指标

主要结局

Comparison of antiemetic effect of Ramosetron with combination of Ondansetron and Dexamethasone in patients undergoing laparoscopic cholecystectomy

时间窗: 0-48 hrs post-operative period

patients will be monitored for vitals, nausea, vomiting, any adverse effect of drug and pain in post-operative period upto 48hrs

次要结局

未报告次要终点

研究者

发起方
Government Medical College, Haldwani
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Shagufta Ansari

COMPARATIVE STUDY OF ANTIEMETIC EFFECT OF RAMOSETRON WITH COMBINATION OF ONDANSETRON AND DEXAMETHASONE IN PATIENT UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY

Government Medical College, Haldwani

研究点 (1)

Loading locations...

相似试验

Post-operative Nausea Vomiting in Laparoscopic... | 临床试验