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临床试验/CTRI/2024/03/064103
CTRI/2024/03/064103
尚未招募
1/2 期

Comparison of effect of intraperitoneal versus intravenous dexamethasone on postoperative nausea, and vomiting after laparoscopic cholecystectomy: A prospective, randomised, double blinded study

Principal, Midnapore Medical College & Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月12日最近更新:

概览

阶段
1/2 期
状态
尚未招募
发起方
Principal, Midnapore Medical College & Hospital
入组人数
100
试验地点
1
主要终点
Incidence and severity of post operative nausea and vomiting

概览

简要总结

SUMMARY:

Proposed topic of research : COMPARISON OF EFFECT OF INTRAPERITONEAL VERSUS INTRAVENOUS DEXAMETHASONE ON POSTOPERATIVE NAUSEA, AND VOMITING AFTER LAPAROSCOPIC CHOLECYSTECTOMY: A PROSPECTIVE, RANDOMISED, DOUBLE BLINDED STUDY.

 **Objective of research:**Comparison of efficacy of Intraperitoneal Dexamethasone with Intravenous Dexamethasone in preventing Post operative nausea & vomiting.**Background of research:**Despite all of the benefits provided by laparoscopic cholecystectomy, the Post operative nausea & vomiting is the common & distressful side effect of laparoscopic surgeries. It can negatively affect patient dissatisfaction; readmission & prolonged hospital stay and  increased medical costs. Multimodal approaches are being considered for prophylaxis of post operative nausea & vomiting. Intravenous Dexamethasone reduces post operative nausea & vomiting after laparoscopic surgeries. In this study we aim to find out if Intraperitoneal Dexamethasone would work better than Intravenous  Dexamethasone to reduce post operative nausea & vomiting following laparoscopic cholecystectomy in adult female patients.

 **Methodology:**It is a hospital based prospective, randomized, double blinded, study on adult female patients undergoing laparoscopic cholecystectomy under general anaesthesia in surgery OT of Midnapore Medical College and Hospital. A total of  100 patients will be selected randomly in two groups where one group will Receive prophylactic dexamethasone 8mg IV, the second group will receive Dexamethasone 8mg IP.  Anaesthetic and surgical management will be standardized in each group. The required parameters will be monitored in the intraoperative and postoperative period up to 24 hours postoperative period  .

***Expected outcome of proposed study:***We are expecting that incidence & severity of PONV will significantly decrease in the group intraperitoneal Dexamethasone group following laparoscopic cholecystectomy.

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
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • ASA grade I & II.
  • Female patients.
  • Patients undergoing laparoscopic Cholecystectomy.
  • Patients giving valid consents.

排除标准

  • Patients with severe cardio-respiratory disease
  • Patients with hepatic & renal disease
  • Patients with neurologic disorder
  • Patients with endocrine disorder
  • Patients who will not give valid consent.
  • Patients with H/O dexamethasone allergy.
  • Patients with pregnancy.

结局指标

主要结局

Incidence and severity of post operative nausea and vomiting

时间窗: 2, 4, 8, 12, and 24 hours after laparoscopy.

次要结局

  • 1. To compare the requirement of rescue antiemetic between the two groups.(2. To compare the requirement of rescue analgesic between the two groups during the first 24hour)

研究者

发起方
Principal, Midnapore Medical College & Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Bijoy Kumar Bandyopadhyay

Midnapore Medical College & Hospital

研究点 (1)

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