CTRI/2023/04/051448已完成不适用
Evaluate and compare the effects of intravenous dexmedetomidine andmagnesium sulphate as adjunct to general anesthesia on perioperative haemodynamicsvariability in patient undergoing laparoscopic cholecystectomy
Pt B. D. Sharma University Of Health Sciences, PGIMS,Rohtak, Haryana1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2023年4月30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
- 69
- 试验地点
- 1
- 主要终点
- To compare the changes in HR & MAP during laryngoscopy and intubation, creation & release of pneumoperitoneum and extubation.
研究概览
简要总结
This study is to investigate the effect of dexmedetomidine and magnesium sulphate used as adjunct to general anaesthesia on perioperative haemodynamic response to laryngoscopy, intubation, pneumoperitoneum and extubation in patients undergoing laparoscopic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator 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
- •American society of Anesthesiology grade I and II between the age of 18-65 years, of either sex and posted for laparoscopic cholecystectomy under general anaesthesia.
排除标准
- •Patients with major hepatic, renal and endocrine dysfunction, cardiovascular dysfunction; neuromuscular, neurological disorder, atrioventricular conduction disturbance, COPD, asthma, obstructive sleep apnea and haematological disorders.
- •Patients with difficult airway.
- •Patients with known allergy to dexmedetomidine or magnesium sulphate.
- •Pregnancy, obesity (body mass index>30 kg m-2), hypertension, diabetes mellitus, and major systemic illness Patients on treatment with calcium channel blockers, beta-blockers, alpha 2 adrenergic agonists or opioid abuse Any intraoperative surgical complication like prolonged surgery (duration more than two hours) or conversion to open surgery, Patient’s unwillingness to participate in the study.
结局指标
主要结局
To compare the changes in HR & MAP during laryngoscopy and intubation, creation & release of pneumoperitoneum and extubation.
时间窗: T0 baseline data | T1 following completion of study drug infusion | T2 1 minute after induction | T3 1 minute after intubation | T4 after peritoneal insufflation | T5 15 min after peritoneal insufflation T6 after peritoneal deflation | T7 1 min after extubation | T8 60 min after extubation
次要结局
- To observe and compare intraoperative anaesthesia requirement, extubation time, time to first rescue analgesic requirement and postoperative sedation(Intraop requirement of total propofol, fentanyl, muscle relaxant and mean end tidal sevoflurane concentration ;Extubation time; Duration of surgery; Time to first rescue analgesia- time from extubation to time when pain reported by patient was ≥4 on visual analogue scale. Injection paracetamol l5mg/kg IV will be used ,If the patient doesn’t get relief in 15 min Injection diclofenac 1.5mg/kg will be given; Post op sedation level will be assessed at 1,15,30, 60 min using Ramsay sedation score)
研究者
研究点 (1)
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