Anesthesiological Strategies in Elective Craniotomy

Azienda Ospedaliera San Gerardo di Monza411 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

411

Conditions

Anesthesia Craniotomy Neurosurgery

Interventions

Sevoflurane + FentanylDRUG

Sevoflurane is maintained in a MAC range (0.75% to 1.25%) and fentanyl (2-3 microg/kg/hr or 0.7 microg/kg boluses). Just before incision of the scalp, fentanyl (1-2microg/kg/hr) can be supplemented, if necessary

Sevoflurane + RemifentanylDRUG

Sevoflurane is maintained in a MAC range (0.75% to 1.25%) and remifentanil (0.5-0.25 microg/kg/min reduced to 0.05-0.1 microg/kg/min after dural opening). Just before incision of the scalp, remifentanil can be supplemented, if necessary

Propofol + RemifentanylDRUG

Propofol is maintained with continuous infusion at 10 mg/kg/h for the first 10 minutes, then reduced to 8 mg/kg/h for the following 10 minutes and reduced to 6mg/kg/h thereafter and remifentanil 0.5-0.25 microg/kg/min reduced to 0.05-0.1 microg/kg/min after dural opening. Just before incision of the scalp, remifentanil could be supplemented, if necessary

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (15)

Policlinico Consorziale di Bari

Bari, Italy

Ospedale Bellaria Bologna

Bologna, Italy

IRCCS Fondazione San Raffaele Milano

Milan, Italy

Outcomes

Primary Outcomes

Post-anesthesia awaking time, assessed as the interval (min:sec)required to reach an ALDRETE score ≥ 9

Time frame: From estubation to aldrete score ≥ 9

Secondary Outcomes

Neurovegetative stress

Time frame: From induction of anesthesia to 24 hours after surgery

Intraoperative and post-operative adverse events assessment

Time frame: From induction of anesthesia to 24 hours after surgery

Brain relaxation evaluated by a blinded neurosurgeon

Time frame: From induction of anesthesia to 24 hours after surgery

Patient's satisfaction

Time frame: From induction of anesthesia to 24 hours after surgery

Costs of the three strategies

Time frame: From induction of anesthesia to end of surgery

Data from ClinicalTrials.gov

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