Fentanyl versus Dexmedetomidine infusion for attenuation of the stress response to pneumoperitoneum during laparoscopic cholecystectomy: A randomized clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the attenuation of hemodynamic stress response to pneumoperitoneum among study groups.
研究概览
简要总结
This study “Fentanyl versus Dexmedetomidine for Attenuation of the Stress Response to Pneumoperitoneum during Laparoscopic Cholecystectomy: Randomized Clinical Trial.’’ will be conducted in the department of anesthesiology, RIMS, Imphal over a period of two years starting from January 2024. After obtaining ethical clearance and written informed consent, 60 patients (18-60 years, ASA I and II) will be randomized into one of the three group (n=20).
Group A patients will receive Dexmedetomidine 0.2 g/kg/hr given at 10 ml/hr after reconstitution with normal saline. Group B patients will receive Fentanyl 1 /kg/hr given at 10ml/hr after reconstitution with normal saline. Group C (control group) will receive only normal saline 10ml/hr. Infusion will be started just before pneumoperitoneum and continue till deflation of the pneumoperitoneum. Hemodynamic parameter (HR, SBP, DBP, MAP) will be recorded at every 1, 3 and 5 minutes after pneumoperitoneum and then every 10 minutes throughout the pneumoperitoneum. Ramsay sedation score will be monitored post operatively at 15 minutes and 30 minutes at PACU. Time for the first rescue analgesia will be given with Inj Diclofenac 75mg IM (or IV if aqueous) when VAS 4. Complications like postoperative nausea and/or vomiting (PONV) will be recorded.
Data will be recorded in proforma and tabulated in the EXCEL software and analysed using SPSS software. A p-value of less than 0.05 will be considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex.
- •Age groups: 18-60 years.
- •ASA (American Society of Anesthesiology)15 Grade I and II.
- •Undergoing Laparoscopic Cholecystectomy.
排除标准
- •Patients with uncontrolled hypertension despite of treatment.
- •Patient with Diabetes Mellitus (with autonomic neuropathy) despite of treatment.
- •Anticipated Difficult airway.
- •Conversion to open cholecystectomy.
- •Hypersensitive to study drugs.
- •Refusal to give consent.
- •Severely deranged renal and hepatic function.
结局指标
主要结局
To compare the attenuation of hemodynamic stress response to pneumoperitoneum among study groups.
时间窗: Hemodynamic parameters—namely heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP)—will be recorded at multiple defined time points. These include the baseline values recorded before induction of anesthesia, just before the creation of pneumoperitoneum (when the study drug infusion is started), and at 1, 3, and 5 minutes after pneumoperitoneum. Subsequently, these parameters will be monitored at every 10-minute interval throughout the duration of pneumoperitoneum and finally at the time of deflation of the pneumoperitoneum, which also coincides with the stopping of the study drug infusion.groups.
次要结局
- To compare(1. The sedative effects and duration of analgesia.)
研究者
Dojingla Yimchunger
Regional Institute of Medical Sciences, Imphal