Thermoregulatory Challenges In The Operating Room: Dexmedetomidine Versus Nefopam In The Management Of Intraoperative Shivering- A Comparative Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Nefopam is better as compared to dexmedetomidine for control of intraoperative shivering under spinal anesthesia due to its rapid onset, higher response rate, no sedation, lesser hemodynamic alterations, lesser requirements of rescue analgesics & lesser costs.
研究概览
简要总结
Intraoperative shivering is a frequent complication observed during surgeries performed under regional anesthesia. It can interfere with monitoring, increase oxygen consumption, elevate cardiac workload, and cause significant patient discomfort. Effective and timely management of shivering during surgery is therefore essential for patient safety and comfort.Dexmedetomidine, a selective Alpha 2-adrenergic agonist, has been shown to possess anti-shivering properties through central thermoregulatory modulation and mild sedative effects. Nefopam, a non-opioid, centrally acting analgesic, also has anti-shivering effects by inhibiting the reuptake of serotonin, norepinephrine, and dopamine. Both agents are known to be effective individually, but comparative data on their efficacy and safety for intraoperative shivering are limited.
This randomized, double-blind, controlled clinical trial is designed to compare the efficacy and safety of intravenous dexmedetomidine and nefopam for the control of intraoperative shivering in adult patients undergoing elective surgeries. The primary objective is to assess which drug is more effective in controlling shivering during surgery with minimal adverse effects. Secondary objectives include evaluation of sedation levels, hemodynamic stability, and incidence of drug-related side effects.
This study aims to generate clinical evidence that can guide anesthesiologists in choosing the most appropriate pharmacologic agent for managing intraoperative shivering.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients Undergoing Elective Surgeries Under Regional Anaesthesia.
排除标准
- •Known Hypersensitivity To Study Drugs Severe Cardiovascular, Respiratory, Renal, Hepatic And Neurological Diseases.
- •Patients With A Contraindication To Regional Anaesthesia.
结局指标
主要结局
Nefopam is better as compared to dexmedetomidine for control of intraoperative shivering under spinal anesthesia due to its rapid onset, higher response rate, no sedation, lesser hemodynamic alterations, lesser requirements of rescue analgesics & lesser costs.
时间窗: Baseline
次要结局
- Nefopam is better as compared to dexmedetomidine for control of intraoperative shivering under spinal anesthesia due to its rapid onset, higher response rate, no sedation, lesser hemodynamic alterations, lesser requirements of rescue analgesics & lesser costs.(Baseline)
研究者
Dr Ambati Santosha Lakshmi
Gitam Institute Of Medical Sciences And Research