To compare the efficacy of continuous infusion of remifentanil versus discontinuation of remifentanil during tracheal extubation in neurosurgical patients using intraoperative neurophysiological monitoring: A prospective, randomized, double-blind study.

Brief Summary

Tracheal extubation in neurosurgical patients is a critical phase of anesthesia associated with significant stress responses such as coughing, agitation, hypertension, and tachycardia, which can lead to adverse neurological consequences. These responses are especially concerning in patients undergoing neurosurgical procedures with intraoperative neurophysiological monitoring (IONM), where hemodynamic stability and smooth emergence are essential to prevent secondary brain injury.

Remifentanil is an ultra-short-acting opioid with rapid onset and offset, making it suitable for controlling peri-extubation stress responses without delaying recovery. However, there is limited evidence regarding whether continuing or discontinuing remifentanil infusion during tracheal extubation provides better outcomes in neurosurgical patients undergoing IONM.

This prospective, randomized, double-blind study aims to compare the efficacy of continuous infusion of remifentanil versus discontinuation of remifentanil during tracheal extubation in neurosurgical patients. The study will assess hemodynamic stability and quality of extubation as primary outcomes, and emergence characteristics and incidence of adverse events as secondary outcomes. The results of this study are expected to help establish an optimal extubation strategy to improve patient safety and anesthetic outcomes in neurosurgical practice.

Objectives of the Study

Primary Objectives

To compare continuous infusion of remifentanil versus discontinuation of remifentanil during tracheal extubation in neurosurgical patients undergoing IONM with respect to:

• Hemodynamic stability

• Quality of extubation

Secondary Objectives

• To compare the emergence profile, including time to eye opening, response to verbal commands, and time to extubation

• To assess the incidence of adverse events such as coughing, desaturation, laryngospasm, hypertension, tachycardia, and bradycardia

Study Design

Prospective, randomized, double-blind controlled study.

Inclusion Criteria

• Patients aged 18 to 65 years

• ASA physical status I, II, or III

• Patients undergoing elective or emergency neurosurgical procedures requiring intraoperative neurophysiological monitoring

Exclusion Criteria

• Patient refusal to participate

• Known allergy or contraindication to remifentanil or study drugs

Methodology

Eligible patients will be randomly allocated into two groups using a computer-generated randomization sequence. In the control group, both propofol and remifentanil infusions will be discontinued at the start of surgical closure. In the remifentanil group, propofol infusion will be stopped at surgical closure while remifentanil infusion will be continued until tracheal extubation at a predefined target concentration. Patients and outcome assessors will be blinded to group allocation.

Hemodynamic parameters, extubation quality, emergence profile, and adverse events will be recorded and analyzed using appropriate statistical methods.

Study Duration

1 year

Expected Benefits

The study may help identify a safer and more effective extubation strategy, resulting in smoother emergence, improved hemodynamic stability, reduced airway complications, and better overall outcomes in neurosurgical patients.