跳至主要内容
临床试验/CTRI/2025/06/089404
CTRI/2025/06/089404尚未招募Phase 3 4

A randomized comparative study of propofol consumption for achieving adequate bispectral index using intravenous dexmedetomidine versus fentanyl in patients undergoing laparoscopic abdominal surgery under general anesthesia at SMS medical college jaipur

Sawai man singh medical college1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月7日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Mean Propofol consumption using IV Dexmedetomidine to achieve BIS 50

研究概览

简要总结

This randomized comparative study aimed to evaluate the effect of intravenous Dexmedetomidine versus intravenous Fentanyl on Propofol consumption required to achieve an adequate Bispectral Index (BIS) in patients undergoing laparoscopic abdominal surgeries under general anesthesia. Patients were randomly assigned to receive either Dexmedetomidine or Fentanyl as an adjunct to Propofol-based anesthesia. The primary outcome was the total Propofol requirement to maintain a target BIS level. Secondary outcomes included hemodynamic stability and recovery profiles. The study found that Dexmedetomidine significantly reduced Propofol consumption compared to Fentanyl, suggesting it as a more effective adjunct for BIS-guided anesthesia in this surgical context.

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 undergoing elective laparoscopic surgery under general anesthesia Patients consenting to participate Patients having ASA 1 and 2 Patients with mallampatti grade 1 and 2.

排除标准

  • Patient with anticipated difficult bag and mask ventilation Patient with known risk of aspiration Patient with uncompensated cardiovascular pulmonary neurological hepatorenal and endocrine disorders.

结局指标

主要结局

Mean Propofol consumption using IV Dexmedetomidine to achieve BIS 50

时间窗: At induction

Mean Propofol consumption using IV Fentanyl to achieve BIS 50

时间窗: At induction

Mean time to achieve BIS 50 using IV Dexmedetomidine

时间窗: At induction

Mean time to achieve BIS 50 using IV Fentanyl

时间窗: At induction

次要结局

  • Mean hemodynamic parameters SBP DBP MAP HR SPO2(Baseline)

研究者

申办方类型
Government medical college

研究点 (1)

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