CTRI/2025/02/080645尚未招募不适用
Transcutaneous electrical stimulation of P6 acupoint for prevention of post-operative nausea and vomiting in laparoscopic gynaecological surgeries.
Maulana Azad Medical College and associated Lok Nayak Hospital1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2025年2月25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
- 114
- 试验地点
- 1
- 主要终点
- Incidence of Post-operative Nausea and Vomiting
研究概览
简要总结
- Post-operative nausea and vomiting (PONV) is one of the most common causes of patient dissatisfaction after anaesthesia. It has an incidence of about 30 % in all post-surgical patients and upto 80 % in high-risk patients.
- Transcutaneous electrical nerve stimulation (TENS) over P6 acupoint (Nei Guan or Pericardium 6) has been reported to reduce the incidence of PONV. This acupoint is located in between the tendons of palmaris longus and flexor carpi radialis, 4 cm proximal to the distal wrist crease and 1 cm below the skin.
- In this study, we will aim to determine the efficacy of peri-operative P6 acupoint stimulation via TENS in the prevention of PONV in female patients undergoing short duration ( less than 2 hours ), laparoscopic gynaecological surgeries.
- A total of 114 patients with 57 patients in each group will be enrolled for the study. Patients will be explained about the study and written informed consent shall be taken.
- After induction of general anaesthesia, patients will receive either transcutaneous electrical nerve stimulation over P6 acupoint, or pharmacologic PONV prophylaxis using IV Ondansetron, as per their allocated group.
- We will be comparing and assessing the incidence of PONV in the early post-operative period ( 0-6 hours after surgery ) between the group receiving P6 acupoint stimulation and the group receiving intra-venous ondansetron intra-operatively.
- The severity of post-operative nausea and vomiting and the amount of anti-emetics required in the early post-operative period (0-6 hours) by patients in the two groups will be compared.
- This study will be conducted in the Department of Anaesthesiology, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi over a period of 12 months ( 1 year )
- The study is a single-blinded, randomised, active-controlled study.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients scheduled to undergo short-duration (less than 2 hours) laparoscopic gynaecological surgeries.
- •Patients having American Society of Anaesthesiologists (ASA) Physical Status I or II.
排除标准
- •BMI greater than 35 kg/m2
- •Patients having previous unpleasant experience with acupuncture ( for patients who have had prior exposure to acupuncture )
- •Patients with history of neuropsychiatric disorders
- •History of allergic reactions to medications used during Anaesthesia.
结局指标
主要结局
Incidence of Post-operative Nausea and Vomiting
时间窗: 0-6 hours post-operatively
次要结局
- Total Amount of Anti-Emetic Requirement(6 hours post-operatively)
- Severity of Post-operative Nausea and Vomiting (Nausea NRS Scale, Composite Score)(0, 1, 2, 6 hours post-operatively)
研究者
Dr Kirti Nath Saxena
Maulana Azad Medical College and associated Lok Nayak Hospital
研究点 (1)
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