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.
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
Dr Santosh Tharwani
Shri Balaji Institute Of Medical Science , Mowa Raipur CG
