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临床试验/CTRI/2024/07/071160
CTRI/2024/07/071160尚未招募不适用

Comparison of the effect of fentanyl and buprenorphine as an adjuvant to hyperbaric bupivacaine 0.5% in terms of hemodynamic parameters in infraumbilical surgery

Kavya KJ1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2024年8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
192
试验地点
1
主要终点
To compare the frequency of bradycardia and hypotension between buprenorphine and fentanyl

研究概览

简要总结

Upon the acquisition of CTRI registration, IRC, and IEC approval, participants will be given a description of the procedure and asked for their approval. This study will include participants undergoing elective infraumbilical surgery. Once in the operating room, the patient is connected to all the monitors. Under aseptic precautions, the patient is positioned in lateral recumbent position, the local anaesthetic drug hyperbaric bupivacaine 0.5% is taken. As fentanyl and buprenorphine are routinely used as an adjuvant during the administration of spinal anaesthesia, in this study we will be using it as per the discretion of the anaesthesiologist. One of the two adjuvant will be chosen as an additive to the local anesthetic, and the anaesthesiologist will administer spinal anaesthesia. After spinal anaesthesia, I will be monitoring the heart rate and blood pressure for every 2.5 minutes until the end of 30 minutes, and after 30 minutes until 1 hour every 5 minutes. If any itching or pruritus is present throughout this period, it is noted. The time from the spinal anaesthesia will be given until the patient is micturated will be noted. The data will be statistically analyzed.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • ASA physical state â… and â…¡ consenting for the procedure Patients aged between 18-60 undergoing infraumbilical surgery.

排除标准

  • LSCS -Infection -Allergic to local anaesthetics -Coagulation disorder -Profound hypotension -Fixed cardiac output status -Indeterminate neurological disorders -Increased intracranial pressur.

结局指标

主要结局

To compare the frequency of bradycardia and hypotension between buprenorphine and fentanyl

时间窗: 5mins to 1hour post anaesthesia

次要结局

  • To find out how frequently side effects occur like pruritus & urine incontinence(3hours postoperatively)

研究者

发起方
Kavya KJ
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Kavya KJ

Manipal college of Health Professions

研究点 (1)

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