Evaluation of the effect of melatonin premedication on preoperative anxiety, propofol induction dosage, perioperative haemodynamics and quality of recovery : An exploratory study

Manasmita Dalai1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2021年10月9日最近更新: 2021年7月8日

试验速览

阶段: Phase 3 4
状态: 尚未招募
发起方
入组人数: 100
试验地点: 1
主要终点: 1.Preoperative anxiety and sedation

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Melatonin is expected to decrease preoperative anxiety and improve quality of recovery 15 score compared to alprazolam

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 65.00 Year(s)（—）
性别: Female

入选标准

•Female Patient
•18 to 65 years of age undergoing elective laparoscopic gynaecological surgery.

排除标准

•patient not willing to participate
•significant cardiac, hepatic renal dysfunction
•allergy to study drugs
•Patient with a history of chronic use of sedatives or analgesics especially opioids and gabapentinoids
•patients requiring post operative ventilatory support.

结局指标

主要结局

1.Preoperative anxiety and sedation

时间窗: From time in preoperative room till 24hour of surgery

2.Quality of recovery (QoR 15 score)

时间窗: From time in preoperative room till 24hour of surgery

次要结局

1. Induction dosage of propofol(2.Perioperative haemodynamic effects)

研究者

发起方

Manasmita Dalai

申办方类型

Other [self]

研究点 (1)

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