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临床试验/CTRI/2024/08/073057
CTRI/2024/08/073057已完成不适用

Comparing the efficacy of Ondansetron vs palonosetron in prevention of shivering under spinal anesthesia in patients undergoing transurethral resection of the prostate

velammal medical college and hospital1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
130
试验地点
1
主要终点
1. Temperature

研究概览

简要总结

Shivering, an involuntary skeletal muscle activity, commonly triggered by hypothermia, poses challenges in the perioperative period, affecting postoperative recovery. Pharmacological interventions, including opioids and 5-HT3 receptor antagonists, aim to alleviate shivering. Ondansetron, a first-gen antiemetic, has demonstrated efficacy in preventing shivering in diverse surgeries. Palonosetron, a newer 5-HT3 antagonist with an extended half-life and higher receptor affinity, holds promise but lacks conclusive evidence. While Ondansetron’s effectiveness is supported by studies in cesarean section and hernia repair, direct comparisons with Palonosetron are limited. Insights from studies on serotonin receptor antagonists, like ramosetron, offer relevant information. Considering the context of Transurethral Resection of the Prostate (TURP), understanding its complications, management, and procedural outcomes is crucial. Although literature predominantly features Ondansetron, a gap exists in direct comparisons between Ondansetron and Palonosetron in preventing shivering during TURP under spinal anesthesia. Further research specific to TURP patients is essential for conclusive evidence on the comparative efficacy of these medications. Hence this study aimed to compare the efficacy of ondansetron and palonosetron in preventing Post-Anesthesia Shivering (PAS) in patients undergoing TURP procedures under spinal anesthesia. Shivering, characterized as an involuntary and repetitive activity of skeletal muscles, is primarily triggered by hypothermia but has also been documented in normothermic patients. The etiological mechanisms involve hypothesized pathways mediated by uninhibited spinal reflexes, postoperative pain, and hyperactive sympathetic activities. Variations in the frequency and patterns of shivering are observed across different anesthesia modalities.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
40.00 Year(s) 至 80.00 Year(s)(—)
性别
Male

入选标准

  • Age 40–80 years, ASA grading I, II Patients undergoing elective TURP procedures.

排除标准

  • 未提供

结局指标

主要结局

1. Temperature

时间窗: 1. Sublingual temperature readings were taken before surgery commencement and subsequently recorded at 30-minute intervals for the next 120 minutes. | 2. The shivering grading system followed was adapted from the study conducted by Wrench et al. Patients were observed intraoperatively and for 120 minutes postoperatively.

2. Shivering-UL/LL

时间窗: 1. Sublingual temperature readings were taken before surgery commencement and subsequently recorded at 30-minute intervals for the next 120 minutes. | 2. The shivering grading system followed was adapted from the study conducted by Wrench et al. Patients were observed intraoperatively and for 120 minutes postoperatively.

次要结局

  • pulse rate(blood pressure)

研究者

发起方
velammal medical college and hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Renganathan Sockalingam

Velammal Hospital and Medical College

研究点 (1)

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