Comparison of opioid-free versus opioid-based anaesthesia for Supratentorial surgery; A prospective, randomized controlled study
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- The primary outcome of the study is to compare the following between the intervention and comparator groups:
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The primary outcome of the study is to compare the following between the intervention and comparator groups:
Time Frame: 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:
Time Frame: 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.
Time Frame: 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:
Time Frame: 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.
Time Frame: 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:
Time Frame: 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.
Time Frame: 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:
Time Frame: 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.
Time Frame: 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
Secondary Outcomes
- Postoperative Nausea and Vomiting (PONV):
Investigators
Dr Lalam Naresh
AIIMS, Raipur