Anesthesiological Strategies in Elective Craniotomy (Neuromorfeo)

Azienda Ospedaliera San Gerardo di Monza

Status and phase: Completed; Phase 3

Conditions: Craniotomy; Neurosurgery; Anesthesia

Treatments: Drug: Sevoflurane + Fentanyl; Drug: Sevoflurane + Remifentanyl; Drug: Propofol + Remifentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT00741351

EudraCT number 2007-005279-32

AIFA FARM6FKJKK

Details and patient eligibility

About

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

Full description

NeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for a elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state evaluated with the ASA (I-III) and Glasgow Coma Scale (GCS) equal to 15, will be randomly assigned to one of three anesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil). The equivalence between intravenous and volatile-based neuroanesthesia will be evaluated by comparing the intervals required to reach, after anesthesia discontinuation, a modified Aldrete score ≥ 9 (primary end-point). Two statistical comparisons have been planned: 1) sevoflurane + fentanyl vs. propofol + remifentanil; 2) sevoflurane + remifentanil vs. propofol + remifentanil.

Secondary end-points include: an assessment of neurovegetative stress based on (a) measurement urinary catecholamines and plasma and urinary cortisol and (b) estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded during anesthesia; intraoperative adverse events (i.e. hypotension, hypertension, requirement of osmotic agents or/and hyperventilation for controlling brain swelling); evaluation of surgical field; postoperative adverse events (as seizures, cough, shivering, agitation, postoperative hematoma and postoperative pain); patient's satisfaction and an analysis of costs.

411 patients will be recruited in 14 different Italian centers during an 18-month period.

The recruitment started December 20th, 2007 and up to 11th March 2009.

Enrollment: 411 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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411 participants in 3 patient groups

IF

Experimental group

Description:

Sevoflurane (Inhalation)+Fentanyl

Treatment:

Drug: Sevoflurane + Fentanyl

IR

Experimental group

Description:

Sevoflurane (Inhalation)+Remifentanyl

Treatment:

Drug: Sevoflurane + Remifentanyl

ER

Experimental group

Description:

Propofol (Endovenous)+ Remifentanyl

Treatment:

Drug: Propofol + Remifentanyl