Anesthesiological Strategies in Elective Craniotomy

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This protocol, NeuroMorfeo, aims to assess equivalence between volatile and intravenous anesthetics for neurosurgical procedures.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera San Gerardo di Monza
• Treatments: Fentanyl; Propofol; Remifentanil; Sevoflurane

Criteria

Inclusion criteria:

• Patient scheduled for elective intracranial surgery under general anesthesia for a supratentorial mass lesion in the next 24 hours;

• Physical state, evaluated with the ASA (American Society of Anesthesiologists ) classification I (normal healthy patient), II (patient with mild systemic disease), or III (patient with severe systemic disease);

• Age 18-75 years;

• Normal preoperative level of consciousness, i.e. Glasgow Coma Scale (GCS) = 15;

• No signs of intracranial hypertension.

Exclusion criteria:

• Severe cardiovascular pathology, as uncontrolled arterial hypertension, documented reduced coronary reserve.

• Renal or liver disease precluding the use of either anesthetic technique.

• Pregnancy .

• Known allergies to any anesthetic agent.

• Reduced preoperative level of consciousness, i.e.

• Glasgow Coma Scale (GCS) < 15.

• Body weight greater than 120 kg.

• History of drug abuse or psychiatric conditions.

• Documented disturbance of the hypothalamic region.Refusal to sign consent form.

• Participation in other clinical trials.

• Delayed awakening, because, due to the location or size of the lesion, postoperative sedation and mechanical ventilation are planned.