临床试验/CTRI/2025/03/082737

CTRI/2025/03/082737尚未招募4 期

Comparison Of Intravenous Nalbuphine Versus Intravenous Tramadol For Postoperative Analgesia In Patients Undergoing Elective Laparoscopic Surgeries-A Randomised Blinded Trial

Narayana Hrudayalaya Hospital1 个研究点分布在 1 个国家目标入组 62 人开始时间: 2025年3月28日最近更新: 2025年3月17日

试验速览

阶段: 4 期
状态: 尚未招募
发起方: Narayana Hrudayalaya Hospital
入组人数: 62
试验地点: 1
主要终点: Mean duration for first rescue analgesic between Nalbuphine vs Tramadol

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

We commonly use Injection.PARACETAMOL intravenously for postoperative pain management in our institution and supplement with Injection. Diclofenac or Tramadol as rescue analgesic.we are all aware of the effect of diclofenac on renal function and nausea with Tramadol, so we wanted to look into other available drugs with minimal effect on Liver and Renal function.

研究设计

研究类型: Interventional
分配方式: Coin toss, Lottery, toss of dice, shuffling cards etc
盲法: Participant and Outcome Assessor Blinded

入排标准

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

入选标准

•American society of Anaethesiologist grade 1& 2.

排除标准

•1.Antipsychotic drugs 2.Drug allergy 3.Opioid use within last 3 months 4.Seizure disorder 5.Anticipation of difficult airway 6.Renal & Liver dysfunction 7.Substance abuse 8.Psychotic disorders.

结局指标

主要结局

Mean duration for first rescue analgesic between Nalbuphine vs Tramadol

时间窗: When VAS score reaches 3/10 in the postoperative period

次要结局

Ramsay sedation score(1st 8 hours of postoperative period)
VAS score between the two groups(1st 8 hours of postoperative period)
Nausea, vomiting, respiratory depression(1st 8 hours of postoperative period)

研究者

发起方

Narayana Hrudayalaya Hospital

申办方类型

Research institution and hospital

责任方

Principal Investigator

主要研究者

Dr Monisha J

Narayana Hrudayalaya Hospital

研究点 (1)

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