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临床试验/CTRI/2025/12/099837
CTRI/2025/12/099837尚未招募不适用

A comparison of Opioid based Vs Non-Opioid based (Subarachnoid blockade) in General Anesthesia for Laparoscopic Hysterectomy: QoR 15 Assessment

PCMC PGI YCM HOSPITAL1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To assess the effects of Non opioid based spinal General Anesthesia versus Opioid based General Anesthesia on the QoR-15 in patients undergoing laparoscopic hysterectomy.

研究概览

简要总结

Patients undergoing Laparoscopic Hysterectomy will be assigned into two groups randomly after CTRI and IEC approval.

To study and compare QoR-15 scores between Non-Opioid based Spinal General Anaesthesia  and Opioid based General Anaesthesia  in patients undergoing Elective Laparoscopic Hysterectomy

PreoperativelyAge Weight Height ASA I OR  II BMI QOR-15 will be recorded Parameters Prior To InductionHeart Rate  Systolic  And Diastolic Blood Pressure  Mean Arterial Pressure  And Saturation Spo2 will be taken. In one group Patients will be given spinal anesthesia in sitting position and after achieving T4 level they will be given General Anesthesia. In other group patients will be given General Anesthesia with Injection Fentanyl. Intraoperatively following parameters will be monitored Heart rate Systolic blood pressure Diastolic blood pressure Mean arterial pressure Oxygen Saturation MAC ETCO2 at post spinal post intubation at pneumoperitoneum insufflation during surgical manipulation at 5 30 60 90 120 150 min intervals at desufflation at extubation and recovery. QOR-15 will be assessed at baseline and postoperatively at 1hr 12hrs  24hrs interval after the surgery

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
40.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • ASA I and II females scheduled for laparoscopic hysterectomy.

排除标准

  • ASA III and IV Patients posted for revision or complicated surgery.

结局指标

主要结局

To assess the effects of Non opioid based spinal General Anesthesia versus Opioid based General Anesthesia on the QoR-15 in patients undergoing laparoscopic hysterectomy.

时间窗: At baseline, after 1 hour , 12 hours and 24 hours post surgery

次要结局

  • To compare hemodynamic parameters in both groups(At baseline, at post spinal, post intubation, at pneumoperitonuem insufflation, during surgery at 5,30,60,90,120 & 150 minuttes interval.)
  • To assess consumption of inhalational agent in both the groups(Intraoperatively)
  • To assess time of regression & time of first rescue analgesia in both the groups(24 hours postoperatively)

研究者

发起方
PCMC PGI YCM HOSPITAL
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR PRIYA CHAVRE

PCMC PGI YCM HOSPITAL

研究点 (1)

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