Comparison of opioid-free versus opioid-based anaesthesia for Supratentorial surgery; A prospective, randomized controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The primary outcome of the study is to compare the following between the intervention and comparator groups:
研究概览
简要总结
This study is a prospective, randomized, single-blinded controlled trial conducted at AIIMS, Raipur, comparing opioid-free and opioid-based anaesthesia in patients undergoing elective supratentorial craniotomy. The study includes adult patients aged 18–65 years with a BMI of 18.5–29.9 kg/m², ASA grade 1 and 2, and a GCS of 15. Exclusion criteria include patients with hepatic, renal, or cardiac insufficiency, uncontrolled hypertension, prior opioid use, raised ICP, or those requiring postoperative ventilation. A total of 70 patients (35 per group) are enrolled based on a sample size calculation derived from previous studies, ensuring 80% power and a 5% significance level.
Patients are randomized into two groups using a computer-generated block randomization method, with allocation concealed in sequentially numbered opaque envelopes. Group A (opioid-free anaesthesia) receives dexmedetomidine (bolus: 0.5 mcg/kg; maintenance: 0.4 mcg/kg/hr) and ketamine (maintenance: 0.25 mg/kg/hr), while Group B (opioid-based anaesthesia) receives fentanyl (bolus: 2 mcg/kg; maintenance: 0.5 mcg/kg/hr). All patients also receive a scalp block with bupivacaine, sevoflurane-based anaesthesia, intravenous acetaminophen infusion, and ondansetron for PONV prophylaxis.
Intraoperative monitoring includes continuous assessment of heart rate, mean arterial pressure, and blood pressure at various surgical stages. Postoperative evaluations include pain scores (NRS/VAS), PONV incidence, and the use of rescue analgesics and anti-emetics at specific intervals: immediate post-op, 30 minutes, 1, 2, 3, 6, 12, and 24 hours. Data are analyzed using unpaired t-tests or Mann-Whitney U tests for quantitative variables and Chi-square or Fisher’s exact tests for qualitative data, with a p-value of <0.05 considered statistically significant. The study aims to evaluate the effectiveness of opioid-free anaesthesia as a potential alternative to opioid-based regimens while minimizing associated side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •Age between 18-65 years BMI: 18.5 to 29.9 kg/m2 Both genders ASA grade 1 and 2 patients Patients undergoing elective supratentorial surgery GCS: 15.
排除标准
- •Patients’ refusal Patients with hepatic, renal, or cardiac insufficiency Patients with uncontrolled hypertension Patients on opioids Inability to understand VAS Score Need for post operative ventilation Patients with features of raised ICP.
结局指标
主要结局
The primary outcome of the study is to compare the following between the intervention and comparator groups:
时间窗: Intraoperative: Continuous monitoring of hemodynamic parameters (HR, MAP) at baseline, after the administration of the study drugs, pre- and post-intubation, pre- and post-skull pin insertion, and throughout the surgery. | Postoperative: Pain and rescue analgesic requirements are assessed at the following time points: | Immediate postoperative period. | 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively
Intraoperative Hemodynamic Variations:
时间窗: Intraoperative: Continuous monitoring of hemodynamic parameters (HR, MAP) at baseline, after the administration of the study drugs, pre- and post-intubation, pre- and post-skull pin insertion, and throughout the surgery. | Postoperative: Pain and rescue analgesic requirements are assessed at the following time points: | Immediate postoperative period. | 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively
Parameters such as heart rate (HR), mean arterial pressure (MAP), systolic and diastolic blood pressure during surgery.
时间窗: Intraoperative: Continuous monitoring of hemodynamic parameters (HR, MAP) at baseline, after the administration of the study drugs, pre- and post-intubation, pre- and post-skull pin insertion, and throughout the surgery. | Postoperative: Pain and rescue analgesic requirements are assessed at the following time points: | Immediate postoperative period. | 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively
Rescue Analgesic Consumption:
时间窗: Intraoperative: Continuous monitoring of hemodynamic parameters (HR, MAP) at baseline, after the administration of the study drugs, pre- and post-intubation, pre- and post-skull pin insertion, and throughout the surgery. | Postoperative: Pain and rescue analgesic requirements are assessed at the following time points: | Immediate postoperative period. | 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively
Total dosage of rescue analgesics required during the intraoperative period.
时间窗: Intraoperative: Continuous monitoring of hemodynamic parameters (HR, MAP) at baseline, after the administration of the study drugs, pre- and post-intubation, pre- and post-skull pin insertion, and throughout the surgery. | Postoperative: Pain and rescue analgesic requirements are assessed at the following time points: | Immediate postoperative period. | 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively
Postoperative Pain:
时间窗: Intraoperative: Continuous monitoring of hemodynamic parameters (HR, MAP) at baseline, after the administration of the study drugs, pre- and post-intubation, pre- and post-skull pin insertion, and throughout the surgery. | Postoperative: Pain and rescue analgesic requirements are assessed at the following time points: | Immediate postoperative period. | 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively
Pain assessment using the Numeric Rating Scale (NRS)/Visual Analog Scale (VAS) scores.
时间窗: Intraoperative: Continuous monitoring of hemodynamic parameters (HR, MAP) at baseline, after the administration of the study drugs, pre- and post-intubation, pre- and post-skull pin insertion, and throughout the surgery. | Postoperative: Pain and rescue analgesic requirements are assessed at the following time points: | Immediate postoperative period. | 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively
Postoperative Rescue Analgesic Consumption:
时间窗: Intraoperative: Continuous monitoring of hemodynamic parameters (HR, MAP) at baseline, after the administration of the study drugs, pre- and post-intubation, pre- and post-skull pin insertion, and throughout the surgery. | Postoperative: Pain and rescue analgesic requirements are assessed at the following time points: | Immediate postoperative period. | 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively
The total dosage of rescue analgesics required in the first 24 hours postoperatively.
时间窗: Intraoperative: Continuous monitoring of hemodynamic parameters (HR, MAP) at baseline, after the administration of the study drugs, pre- and post-intubation, pre- and post-skull pin insertion, and throughout the surgery. | Postoperative: Pain and rescue analgesic requirements are assessed at the following time points: | Immediate postoperative period. | 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, and 24 hours postoperatively
次要结局
- Postoperative Nausea and Vomiting (PONV):
研究者
Dr Lalam Naresh
AIIMS, Raipur