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临床试验/CTRI/2020/12/030121
CTRI/2020/12/030121尚未招募Phase 3 4

comparative study of efficacy of intraperitoneal instillation of 0.2% ropivacaine with dexmedetomidine versus 0.2% ropivacaine with ketamine in laparoscopic surgeries - a randomized study

DUDYALA DHATRI1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
105
试验地点
1
主要终点
To study the total duration of analgesia and total rescue analgesic dose requirements in first 24 hours post operatively.

研究概览

简要总结

Postoperative pain management in laparoscopic surgeries plays a very crucial role in Enhanced Recovery After Surgery. Intraperitoneal instillation of local anesthetic will block the free nerve endings in the peritoneum and thus provide relief from visceral pain.

In this study one group will receive 0.2 % Ropivacaine (30ml) with 0.5mcg/kg Dexmedetomidine (1ml) and other group will receive 0.2 % Ropivacaine (30ml) with 0.5mg/kg Ketamine (1ml). Control group will receive 0.2 % Ropivacaine (30ml) with normal saline (1ml).Three groups will be compared in terms of intensity of static and dynamic pain by VAS score for first 24 hours postoperatively. The total duration of analgesia and total analgesic dose will be compared in three groups.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •PATIENTS WITH ASA PS I & II POSTED FOR ELECTIVE LAPAROSCOPIC SURGERIES.

排除标准

  • •Patient refusal Local anesthetic allergy / drug allergy Pregnancy Patients with Cardiovascular/Respiratory/ Liver/ Renal diseases BMI ≥ 30 Kg/m2 If any other surgeries combined in the same sitting.

结局指标

主要结局

To study the total duration of analgesia and total rescue analgesic dose requirements in first 24 hours post operatively.

时间窗: for every 30 min for first two hours and then at 6 hours,12 hours and 24 hours.

次要结局

  • The hemodynamic parameters intraoperatively and postoperatively.(Incidence of postoperative nausea and vomiting using Likert scale.)

研究者

发起方
DUDYALA DHATRI
申办方类型
Other []

研究点 (1)

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