Anesthesiological Strategies in Elective Craniotomy
- Conditions
- AnesthesiaCraniotomyNeurosurgery
- Interventions
- Registration Number
- NCT00741351
- Lead Sponsor
- Azienda Ospedaliera San Gerardo di Monza
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 411
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ER Propofol + Remifentanyl Propofol (Endovenous)+ Remifentanyl IF Sevoflurane + Fentanyl Sevoflurane (Inhalation)+Fentanyl IR Sevoflurane + Remifentanyl Sevoflurane (Inhalation)+Remifentanyl
- Primary Outcome Measures
Name Time Method Post-anesthesia awaking time, assessed as the interval (min:sec)required to reach an ALDRETE score ≥ 9 From estubation to aldrete score ≥ 9
- Secondary Outcome Measures
Name Time Method Neurovegetative stress From induction of anesthesia to 24 hours after surgery Intraoperative and post-operative adverse events assessment From induction of anesthesia to 24 hours after surgery Brain relaxation evaluated by a blinded neurosurgeon From induction of anesthesia to 24 hours after surgery Patient's satisfaction From induction of anesthesia to 24 hours after surgery Costs of the three strategies From induction of anesthesia to end of surgery
Trial Locations
- Locations (15)
Ospedale Bellaria Bologna
🇮🇹Bologna, Italy
IRCCS Fondazione San Raffaele Milano
🇮🇹Milan, Italy
Istituto di Ricerche Farmacologiche Mario Negri - Dipartimento di Ricerca Cardiovascolare-
🇮🇹Milan, Italy
Azienda Ospedaliera San Gerardo
🇮🇹Monza, Italy
Ospedale San giovanni Battista Torino
🇮🇹Turin, Italy
Ospedale Maggiore della Carità di Novara
🇮🇹Novara, Italy
Ospedale di Padova
🇮🇹Padua, Italy
Azienda Ospedaliera di Parma
🇮🇹Parma, Italy
Policlinico "A. Gemelli" Roma
🇮🇹Rome, Italy
Ospedale San Giovanni Bosco Torino
🇮🇹Turin, Italy
Policlinico "Umberto I" Roma
🇮🇹Rome, Italy
Azienda Universitaria Senese
🇮🇹Siena, Italy
Ospedale di Circolo e Fondazione Macchi Varese
🇮🇹Varese, Italy
Azienda Ospedaliera Universitaria di Verona
🇮🇹Verona, Italy
Policlinico Consorziale di Bari
🇮🇹Bari, Italy