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临床试验/CTRI/2026/03/106072
CTRI/2026/03/106072尚未招募不适用

Effect Of Adding Intravenous Midazolam To A Dual Post Operative Nausea And Vomiting Regimen In Female Patients Undergoing Laparoscopic Surgeries - A Prospective Randomized Control Trial.

Shri Balaji Institute Of Medical Sciences Institutional Sponsor1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年3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
200
试验地点
1

研究概览

简要总结

This prospective randomized controlled trial evaluates the effect of adding intravenous midazolam to a dual antiemetic regimen for preventing postoperative nausea and vomiting PONV in female patients undergoing laparoscopic surgeries PONV is a common and distressing complication with an incidence of 60 to 80 percent in high-risk patients Standard prophylaxis includes dexamethasone and ondansetron however PONV remains significant despite dual therapy Midazolam a short acting benzodiazepine has demonstrated additional antiemetic properties via GABA mediated mechanisms

A total of 200 ASA I and II female patients 18 to 65 years will be randomized into two groups Group A will receive dexamethasone 8 mg with ondansetron 4 mg, while Group B will receive dexamethasone 4 mg ondansetron 4 mg and midazolam 0.04 mg/kg maximum 2 mg PONV incidence within 24 hours is the primary outcome Secondary outcomes include severity VAS rescue antiemetic requirement pain scores sedation patient satisfaction and blood glucose levels The study hypothesizes that midazolam addition significantly reduces PONV incidence and severity

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)

入选标准

  • (1)Age group :
  • 65 years. (2)Gender : Female patients. (3)ASA grades : ASA grade I and II. (4)BMI :
  • (5)Patients posted for elective laparoscopic surgeries. (6)Patients willing to participate and provide informed consent.

排除标准

  • Patient refusal.
  • Body mass index less than 18 kg per square meter or greater than 40 kg per square meter.
  • Known allergy or contraindication to study drugs.
  • History of chronic postoperative nausea and vomiting, chronic headache, or psychiatric disorder.
  • Chronic opioid use for more than 3 months or chronic benzodiazepine use.
  • Prior anticancer chemotherapy within 4 weeks before surgery.
  • Obstructive sleep apnea.
  • Poorly controlled diabetes mellitus defined as HbA1c greater than 9 percent or blood glucose level greater than 180 mg per deciliter on the day of surgery.

研究者

发起方
Shri Balaji Institute Of Medical Sciences Institutional Sponsor
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Santosh Tharwani

Shri Balaji Institute Of Medical Science , Mowa Raipur CG

研究点 (1)

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