Status:
COMPLETED
Anesthesiological Strategies in Elective Craniotomy
Lead Sponsor:
Azienda Ospedaliera San Gerardo di Monza
Conditions:
Anesthesia
Craniotomy
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 le...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
411 Patients enrolled
Trial Details
Trial ID
NCT00741351
Start Date
December 1 2007
End Date
December 1 2009
Last Update
September 8 2011
Active Locations (15)
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1
Policlinico Consorziale di Bari
Bari, Italy
2
Ospedale Bellaria Bologna
Bologna, Italy, 40100
3
IRCCS Fondazione San Raffaele Milano
Milan, Italy, 20100
4
Istituto di Ricerche Farmacologiche Mario Negri - Dipartimento di Ricerca Cardiovascolare-
Milan, Italy, 20100