Clinical trial NCT00741351: Anesthesiological Strategies in Elective Craniotomy
Official title: Anesthesiological Strategies in Elective Craniotomy: Randomized, Equivalence, Open Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Craniotomy
Neurosurgery
Keywords: Anesthesia
Craniotomy
Neurosurgery
Lead sponsor: Azienda Ospedaliera San Gerardo di Monza
Sponsor class: OTHER
First posted: 2008-08-26
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Post-anesthesia awaking time, assessed as the interval (min:sec)required to reach an ALDRETE score ≥ 9
timeFrame: From estubation to aldrete score ≥ 9
Secondary outcomes:
measure: Neurovegetative stress
timeFrame: From induction of anesthesia to 24 hours after surgery
measure: Intraoperative and post-operative adverse events assessment
timeFrame: From induction of anesthesia to 24 hours after surgery
measure: Brain relaxation evaluated by a blinded neurosurgeon
timeFrame: From induction of anesthesia to 24 hours after surgery
measure: Patient's satisfaction
timeFrame: From induction of anesthesia to 24 hours after surgery
measure: Costs of the three strategies
timeFrame: From induction of anesthesia to end of surgery
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Policlinico Consorziale di Bari
city: Bologna
country: Italy
facility: Ospedale Bellaria Bologna
city: Milan
country: Italy
facility: IRCCS Fondazione San Raffaele Milano
city: Milan
country: Italy
facility: Istituto di Ricerche Farmacologiche Mario Negri - Dipartimento di Ricerca Cardiovascolare-
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
city: Novara
country: Italy
facility: Ospedale Maggiore della Carità di Novara
city: Padua
country: Italy
facility: Ospedale di Padova
city: Parma
country: Italy
facility: Azienda Ospedaliera di Parma
city: Rome
country: Italy
facility: Policlinico "A. Gemelli" Roma
city: Rome
country: Italy
facility: Policlinico "Umberto I" Roma
city: Siena
country: Italy
facility: Azienda Universitaria Senese
city: Turin
country: Italy
facility: Ospedale San Giovanni Bosco Torino
city: Turin
country: Italy
facility: Ospedale San giovanni Battista Torino
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi Varese
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria di Verona
Study officials:
affiliation: Azienda Ospedaliera San Gerardo Monza
name: Giuseppe Citerio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Università delgi Studi Milano Bicocca
name: Antonio Pesenti, MD
role: STUDY_CHAIR
affiliation: Istituto Di Ricerche Farmacologiche Mario Negri
name: Maria Grazia Franzosi, PhD
role: STUDY_CHAIR
affiliation: Istituto Di Ricerche Farmacologiche Mario Negri
name: Roberto Latini, MD
role: STUDY_CHAIR
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