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临床试验/CTRI/2024/07/070200
CTRI/2024/07/070200尚未招募不适用

Randomized, double blinded clinical trial to evaluate efficacy of intrathecal clonidine and intrathecal morphine as adjuvants to hyperbaric bupivacaine in spinal anaesthesia for patients undergoing vaginal hysterectomy.

Rajesh Ravi1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年7月19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
140
试验地点
1
主要终点
To compare the duration of postoperative analgesic effect of intrathecal clonidine and morphine when used as adjuvants to hyperbaric bupivacaine in spinal anaesthesia

研究概览

简要总结

Healthy female patients, 18 years of age and older, who are undergoing vaginal hysterectomy under spinal anesthesia will be included in the study after IRB approval and CTRI registration. Patients will be informed about the anesthesia plan and will provide written informed consent a day before the surgery. Patients with contraindications for regional anesthesia will be excluded from the study. The participants will be randomly assigned to two groups. The control group will receive a subarachnoid block with heavy Bupivacaine 0.5% and intrathecal morphine 2 mcg/kg, according to the standard of care in our institution. Patients in the study group will receive a subarachnoid block with heavy Bupivacaine 0.5% and intrathecal clonidine 1 mcg/kg. Both groups will receive the same intraoperative monitoring of vital signs, IV fluids, and anti-emetic medications. The duration of analgesic effect will be measured from the time of spinal administration to the first analgesic request in the postoperative period. The time to regression of motor and sensory blocks will be assessed. Postoperative pain scores, side effects, time to first oral intake, and patient satisfaction scores will be recorded for both groups.

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
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Female

入选标准

  • undergoing Vaginal hysterectomy under spinal anesthesia.

排除标准

  • Patients who have contraindications for regional anaesthesia will be excluded from the study.

结局指标

主要结局

To compare the duration of postoperative analgesic effect of intrathecal clonidine and morphine when used as adjuvants to hyperbaric bupivacaine in spinal anaesthesia

时间窗: 24 hours

次要结局

  • 1. To compare postoperative pain scores in both groups.

研究者

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

Rajesh Ravi

Christian Medical College

研究点 (1)

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