Studying the effects of anesthesia with and without opioids for surgeries on the upper part of the brain: A planned and carefully controlled investigation

Comparison of opioid-free versus opioid-based anaesthesia for Supratentorial surgery; A prospective, randomized controlled study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078216

Enrollment

Registered

2024-12-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C710- Malignant neoplasm of cerebrum, except lobes and ventricles

Interventions

Intervention1: Administration of dexmedetomidine and ketamine: The intervention involves the use of opioid-free anesthesia. The specific agents and their administration include: Dexmedetomidine: Intr

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary outcome of the study is to compare the following between the intervention and comparator groups: Intraoperative Hemodynamic Variations: Parameters such as heart rate (HR), mean arterial pressure (MAP), systolic and diastolic blood pressure during surgery. Rescue Analgesic Consumption: Total dosage of rescue analgesics required during the intraoperative period. Postoperative Pain: Pain assessment using the Numeric Rating Scale (NRS)/Visual Analog Scale (VAS) scores. Postoperative Rescue Analgesic Consumption: The total dosage of rescue analgesics required in the first 24 hours postoperatively.Timepoint: 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	—

Measure

Time frame

The primary outcome of the study is to compare the following between the intervention and comparator groups: Intraoperative Hemodynamic Variations: Parameters such as heart rate (HR), mean arterial pressure (MAP), systolic and diastolic blood pressure during surgery. Rescue Analgesic Consumption: Total dosage of rescue analgesics required during the intraoperative period. Postoperative Pain: Pain assessment using the Numeric Rating Scale (NRS)/Visual Analog Scale (VAS) scores. Postoperative Rescue Analgesic Consumption: The total dosage of rescue analgesics required in the first 24 hours postoperatively.Timepoint: 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

Measure	Time frame
Postoperative Nausea and Vomiting (PONV): Incidence of PONV in the first 24 hours postoperatively. Requirement for rescue anti-emetics. Adverse Effects: Incidence of intraoperative and postoperative adverse effects, including: Bradycardia Hypotension Hypertension TachycardiaTimepoint: PONV and Anti-Emetics: Assessed during the first 24 hours postoperatively at regular intervals (same time points as postoperative pain: immediate postoperative period, 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, and 24 hours). Adverse Effects: Monitored continuously during the intraoperative period and documented whenever they occur. Postoperative adverse effects assessed up to 24 hours after surgery.	—

Measure

Time frame

Postoperative Nausea and Vomiting (PONV): Incidence of PONV in the first 24 hours postoperatively. Requirement for rescue anti-emetics. Adverse Effects: Incidence of intraoperative and postoperative adverse effects, including: Bradycardia Hypotension Hypertension TachycardiaTimepoint: PONV and Anti-Emetics: Assessed during the first 24 hours postoperatively at regular intervals (same time points as postoperative pain: immediate postoperative period, 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, and 24 hours). Adverse Effects: Monitored continuously during the intraoperative period and documented whenever they occur. Postoperative adverse effects assessed up to 24 hours after surgery.

—

Countries

India

Contacts

Public ContactDr Monica Malhotra

AIIMS, Raipur

monicakhetrapal@yahoo.com8518881714

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026