跳至主要内容
临床试验/CTRI/2025/08/093415
CTRI/2025/08/093415尚未招募4 期

To Study the effect of olanzapine and amisulpride in post operative nausea and vomiting in laparoscopic gynecological surgeries -A randomized double-blind study

IMS AND SUM HOSPITAL1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
121
试验地点
1
主要终点
To monitor postoperative nausea and vomiting for 24 hrs

研究概览

简要总结

1.This prospective randomized double blinded comparative study will be conducted at our

institution over a period of 1.5 years.

2.In this study 110 ASA grade I and II patients between age 20 to 50 years posted for elective

laparoscopic gynecological surgeries requiring general anesthesia will be included.

3.After taking written informed consent, patients will be randomized into two groups (n= 110)by

computer generated random number table.

4.All patients will be thoroughly examined pre- operatively which includes history, general

physical examination, and checking the vital parameters, and systemic examination and ASA

grading of patients.

5.All the patients will be kept empty stomach for at least 6 hours before the procedure.

6.All the routine monitors will be attached and the preoperative baseline parameters (noninvasive

blood pressure, (NIBP), pulse rate (PR), and saturation (SPO2) )will be noted.An 18-Gauge IV

cannula will be secured all patients irrespective of the group they belong to.

7.Patients in group A will receive Inj amisulpride 5 mg slow iv 30 mins before induction .

Patients in group B will receive T.olanzapine 10mg P/O 90 mins before induction.

8.Patients will be given following premedication drugs, Inj glycopyrrolate 0.2mg iv ,Inj

Midazolam 1mg iv, Inj fentanyl(2mcg/kg) and induced with Inj propofol(1.5mg/kg) iv and Inj

vecuronium (0.1mg/kg) iv as muscle relaxant initially and followed by 0.02mg as maintenance.

9.At the end of Surgery patients will be extubated and monitored for postoperative nausea and

vomiting from ‘0’ hours .

10.Initial 2 hours: Monitoring every 30 minutes ,Then 2hrs,4hrs,6hrs,8hrs,12hrs,18hrs,24hrs.

11.Rescue antiemetic Inj dexamethasone 8 mg will be given if a patient develops postoperative

nausea and vomiting irrespective of the drug given.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Patients between age 20 to 50 years posted for elective laparoscopic gynecological surgeries requiring general anesthesia will be included.

排除标准

  • 1.Refusal to participate in the study 2.Pregnant or lactating female 3.Patient having cardiovascular/neurological condition 4.Patients on Antipsychotic medication 5.History of allergy to study drug.

结局指标

主要结局

To monitor postoperative nausea and vomiting for 24 hrs

时间窗: Incidence of postoperative nausea and vomiting will be assessed at the following time points :0.5hr,1hr,1.30hr,2hr,4hr,6hr,8hr,12hr,18hr and 24hr

次要结局

  • 1.Time of rescue antiemetic(2.Total dose of rescue antiemetic.)

研究者

发起方
IMS AND SUM HOSPITAL
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr NithishT

IMS & SUM Hospital

研究点 (1)

Loading locations...

相似试验