CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 411 enrolled
Drug / intervention
Sevoflurane + Fentanyl +2 moredrug
Likely dose
Propofol + Remifentanyl 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00741351
NCT00741351Phase 3Completed

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

Azienda Ospedaliera San Gerardo di Monza·interventional·Posted Aug 26, 2008·Updated Sep 8, 2011

In Brief

A Phase 3 clinical trial evaluating Sevoflurane + Fentanyl, Sevoflurane + Remifentanyl, and 1 other intervention for Anesthesia and 2 related conditions. Completed, enrolled 411 participants across 15 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 26, 2008
Enrollment StartDec 1, 2007
Primary CompletionMar 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.8 years ago

Interventions

Sevoflurane + Fentanyldrug

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

Sevoflurane + Remifentanyldrug

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

Propofol + Remifentanyldrug

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