Anesthesiological Strategies in Elective Craniotomy (Neuromorfeo)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dott. Giuseppe Citerio, Azienda Ospedaliera San Gerardo di Monza
ClinicalTrials.gov Identifier:
NCT00741351
First received: August 22, 2008
Last updated: September 7, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Anesthesia
Craniotomy
Neurosurgery
Drug: Sevoflurane + Fentanyl
Drug: Sevoflurane + Remifentanyl
Drug: Propofol + Remifentanyl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anesthesiological Strategies in Elective Craniotomy: Randomized, Equivalence, Open Trial

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera San Gerardo di Monza:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurovegetative stress [ Time Frame: From induction of anesthesia to 24 hours after surgery ] [ Designated as safety issue: No ]
  • Intraoperative and post-operative adverse events assessment [ Time Frame: From induction of anesthesia to 24 hours after surgery ] [ Designated as safety issue: Yes ]
  • Brain relaxation evaluated by a blinded neurosurgeon [ Time Frame: From induction of anesthesia to 24 hours after surgery ] [ Designated as safety issue: No ]
  • Patient's satisfaction [ Time Frame: From induction of anesthesia to 24 hours after surgery ] [ Designated as safety issue: No ]
  • Costs of the three strategies [ Time Frame: From induction of anesthesia to end of surgery ] [ Designated as safety issue: No ]

Enrollment: 411
Study Start Date: December 2007
Study Completion Date: December 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IF
Sevoflurane (Inhalation)+Fentanyl
Drug: Sevoflurane + Fentanyl
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
Experimental: IR
Sevoflurane (Inhalation)+Remifentanyl
Drug: Sevoflurane + Remifentanyl
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
Experimental: ER
Propofol (Endovenous)+ Remifentanyl
Drug: Propofol + Remifentanyl
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741351

Locations
Italy
Policlinico Consorziale di Bari
Bari, Italy
Ospedale Bellaria Bologna
Bologna, Italy, 40100
Istituto di Ricerche Farmacologiche Mario Negri - Dipartimento di Ricerca Cardiovascolare-
Milan, Italy, 20100
IRCCS Fondazione San Raffaele Milano
Milan, Italy, 20100
Azienda Ospedaliera San Gerardo
Monza, Italy, 20052
Ospedale Maggiore della Carità di Novara
Novara, Italy, 28100
Ospedale di Padova
Padua, Italy, 35128
Azienda Ospedaliera di Parma
Parma, Italy, 43100
Policlinico "A. Gemelli" Roma
Rome, Italy
Policlinico "Umberto I" Roma
Rome, Italy
Azienda Universitaria Senese
Siena, Italy, 53100
Ospedale San giovanni Battista Torino
Turin, Italy
Ospedale San Giovanni Bosco Torino
Turin, Italy, 10057
Ospedale di Circolo e Fondazione Macchi Varese
Varese, Italy, 21100
Azienda Ospedaliera Universitaria di Verona
Verona, Italy, 37121
Sponsors and Collaborators
Azienda Ospedaliera San Gerardo di Monza
Investigators
Principal Investigator: Giuseppe Citerio, MD Azienda Ospedaliera San Gerardo Monza
Study Chair: Antonio Pesenti, MD Università delgi Studi Milano Bicocca
Study Chair: Maria Grazia Franzosi, PhD Istituto Di Ricerche Farmacologiche Mario Negri
Study Chair: Roberto Latini, MD Istituto Di Ricerche Farmacologiche Mario Negri
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dott. Giuseppe Citerio, MD, Azienda Ospedaliera San Gerardo di Monza
ClinicalTrials.gov Identifier: NCT00741351     History of Changes
Other Study ID Numbers: EudraCT number 2007-005279-32, AIFA FARM6FKJKK
Study First Received: August 22, 2008
Last Updated: September 7, 2011
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Azienda Ospedaliera San Gerardo di Monza:
Anesthesia
Craniotomy
Neurosurgery

Additional relevant MeSH terms:
Fentanyl
Propofol
Remifentanil
Sevoflurane
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on April 22, 2014