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临床试验/CTRI/2025/03/082618
CTRI/2025/03/082618尚未招募不适用

A Prospective Randomised Controlled Study Comparing the effects of Dexmedetomidine versus Remifentanil Infusion on Perioperative Hemodynamics and Recovery Profiles in Elderly Patients undergoing Robotic surgeries

Fortis Hospital1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年3月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
84
试验地点
1
主要终点
1)The recovery time in both the groups (response to verbal commands, extubation time and orientation time)

研究概览

简要总结

In our study, we are comparing the effects of intraoperative infusion of dexmedetomidine and remifentanil on perioperative hemodynamics and recovery profiles in elderly patients undergoing robotic surgeries. Existing literature have tried to compare and assess various parameters like intraoperative blood loss, hemodynamics, post- operative pain scores and other side effects like PONV, shivering and sedation scores. Most of the studies have been in conducted in, a wide range of patient age profiles and in short duration surgeries .There are limited studies comparing the recovery profiles of elderly patients undergoing major robotic surgeries which is associated with prolonged surgical duration ,pneumoperitoneum and extreme patient positioning . Hence, in this study we describe our adaption of comparing dexmedetomidine versus remifentanil as a part of enhanced recovery in elderly patients undergoing robotic surgeries.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Aged more than 60years 2) ASA I and 2 listed for robotic surgeries with duration more than 3hours.

排除标准

  • Aged less than 59 years.
  • Refusal by patient.
  • Patients with severe respiratory disease or ischemic cardiac findings on ECG or cardiac conductive defects belonging to ASA 3 or 4 4) Obese patient with BMI greater than 35 4) Patients on beta blockers with a basal heart rate less than 55beats per minute.

结局指标

主要结局

1)The recovery time in both the groups (response to verbal commands, extubation time and orientation time)

时间窗: 1)Recovery Profiles-Immediately after the surgery | 2)Baseline ,Induction time,Every half an hourly during the surgery till the surgery gets over the heart rate and blood pressure will be monitored

2)The perioperative hemodynamics in both groups

时间窗: 1)Recovery Profiles-Immediately after the surgery | 2)Baseline ,Induction time,Every half an hourly during the surgery till the surgery gets over the heart rate and blood pressure will be monitored

次要结局

  • 1)Comparing the post operative cognition in both groups(2)Comparing post operative nausea, vomiting, sedation scores & pain scores in 2 groups)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Ruby J Babu

Fortis Hospital

研究点 (1)

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