Anesthesiological Strategies in Elective Craniotomy (Neuromorfeo)

September 7, 2011 updated by: Dott. Giuseppe Citerio, Azienda Ospedaliera San Gerardo di Monza

Anesthesiological Strategies in Elective Craniotomy: Randomized, Equivalence, Open Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

411

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy
        • Policlinico Consorziale di Bari
      • Bologna, Italy, 40100
        • Ospedale Bellaria Bologna
      • Milan, Italy, 20100
        • IRCCS Fondazione San Raffaele Milano
      • Milan, Italy, 20100
        • Istituto di Ricerche Farmacologiche Mario Negri - Dipartimento di Ricerca Cardiovascolare-
      • Monza, Italy, 20052
        • Azienda Ospedaliera San Gerardo
      • Novara, Italy, 28100
        • Ospedale Maggiore della Carità di Novara
      • Padua, Italy, 35128
        • Ospedale di Padova
      • Parma, Italy, 43100
        • Azienda Ospedaliera di Parma
      • Rome, Italy
        • Policlinico "A. Gemelli" Roma
      • Rome, Italy
        • Policlinico "Umberto I" Roma
      • Siena, Italy, 53100
        • Azienda Universitaria Senese
      • Turin, Italy, 10057
        • Ospedale San Giovanni Bosco Torino
      • Turin, Italy
        • Ospedale San giovanni Battista Torino
      • Varese, Italy, 21100
        • Ospedale di Circolo e Fondazione Macchi Varese
      • Verona, Italy, 37121
        • Azienda Ospedaliera Universitaria di Verona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From estubation to aldrete score ≥ 9

Secondary Outcome Measures

Outcome Measure
Time Frame
Neurovegetative stress
Time Frame: From induction of anesthesia to 24 hours after surgery
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
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
From induction of anesthesia to 24 hours after surgery
Patient's satisfaction
Time Frame: From induction of anesthesia to 24 hours after surgery
From induction of anesthesia to 24 hours after surgery
Costs of the three strategies
Time Frame: From induction of anesthesia to end of surgery
From induction of anesthesia to end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 25, 2008

First Posted (ESTIMATE)

August 26, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 8, 2011

Last Update Submitted That Met QC Criteria

September 7, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT number 2007-005279-32
  • AIFA FARM6FKJKK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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