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临床试验/CTRI/2024/10/075326
CTRI/2024/10/075326进行中(未招募)不适用

Comparison of Two Different Doses of Dexamethasone for Attenuation of Post Spinal Anaesthesia Hypotension: A Prospective, Randomized, Double-blind, Clinical Study.

AIIMS Rajkot1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2024年10月21日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
184
试验地点
1
主要终点
Proportion of patients who developed Post Spinal hypotension (PSH) within 20 minutes of spinal anaesthesia.

研究概览

简要总结

Spinal anaesthesia is the preferred mode of anaesthesia for infra-umbilical surgeries owing to its simplicity, ease, better post-operative analgesia and lesser side effects like nausea and vomiting. However, hypotension is a common complication after SA with a reported occurrence in 16–33% of cases which limits its use in some patients. Various methods like volume loading and vasopressor injection have been utilized to attenuate post-spinal hypotension (PSH) with varied success. Limited research is available comparing the efficacy of dexamethasone to attenuate PSH. Hence, this study aims to compare the effect of 4 and 8 mg of IV dexamethasone in prevention of PSH.

After taking the informed consent, patients will be randomly assigned to one of either group- Group D4 (Dexamethasone 4mg) or Group D8 (Dexamethasone 8mg). Two hours prior to Spinal Anaesthesia patient will receive IV 100ml of 0.9% Normal Saline in which the study drug will be dissolved as per the group allocation (Dexamethasone 4mg/ 8mg). The rest of the procedure will be as per standard care of the operation.

During perioperative period, patient will be evaluated for hypotension, bradycardia, blood glucose levels, requirement of vasopressors and occurrence of other side effects like nausea, vomiting and shivering.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA grdae I, II & III patients posted for elective lower abdominal and lower limb surgeries under spinal anesthesia.

排除标准

  • Patient refusal Emergency surgery Pregnant patients Any contraindications to spinal anaesthesia Patients on steroids.

结局指标

主要结局

Proportion of patients who developed Post Spinal hypotension (PSH) within 20 minutes of spinal anaesthesia.

时间窗: Mean blood pressure (MBP) will be recorded before giving the study medication (base line) and then after Spinal Anaesthesia every 5 min for 20 minutes.

次要结局

  • Severity of Post Spinal hypotension (PSH).(After spinal anaesthesia till 6 hours post operative period.)
  • Number of patients requiring ephedrine/atropine.(After spinal anaesthesia till 6 hours post operative period.)
  • Total dose of ephedrine required.(After Spinal anaesthesia till 6 hours post operative period)
  • Effect on perioperative blood glucose levels.
  • Occurrence of other side effects (nausea/vomiting/shivering).(After spinal anaesthesia till 6 hours of post opertive period.)

研究者

发起方
AIIMS Rajkot
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Anita Saran

AIIMS Rajkot

研究点 (1)

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