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Anesthesiological Strategies in Elective Craniotomy

NCT00741351 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 411

Last updated 2011-09-08

No results posted yet for this study

Summary

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

Conditions

  • Anesthesia
  • Craniotomy
  • Neurosurgery

Interventions

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

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

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

Sponsors & Collaborators

  • Azienda Ospedaliera San Gerardo di Monza

    lead OTHER

Principal Investigators

  • Giuseppe Citerio, MD · Azienda Ospedaliera San Gerardo Monza

  • Antonio Pesenti, MD · Università delgi Studi Milano Bicocca

  • Maria Grazia Franzosi, PhD · Istituto Di Ricerche Farmacologiche Mario Negri

  • Roberto Latini, MD · Istituto Di Ricerche Farmacologiche Mario Negri

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-03-31
Completion
2009-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00741351 on ClinicalTrials.gov