CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 622 enrolled
Drug / intervention
Remifentanil +1 moredrug
Likely dose
Remifentanil 2mg/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/NCT01627873
NCT01627873Phase 4Completed

Effect of Remifentanil on Postoperative Cognitive Function in Patients Undergoing Major Abdominal Surgery

Catholic University of the Sacred Heart·interventional·Posted Jun 26, 2012·Updated Jun 26, 2012

In Brief

A Phase 4 clinical trial evaluating Remifentanil and Fentanyl for Patients Undergoing Major Abdominal Surgery and Postoperative Confusion. Completed, enrolled 622 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate the effects of two different analgesic methods (Fentanyl vs Remifentanil) during major abdominal surgery on postoperative cognitive status of patients.

Study Details

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

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 26, 2012
Enrollment StartAug 1, 2009
Primary CompletionJul 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.0 years ago

Interventions

Remifentanildrug

In group A induction of anesthesia will be performed with Propofol (2mg/kg), Cisatracurium (0.15mg/kg)and continous infusion of Remifentanil (0.15mcg/kg/min).Anesthesia will be maintained by Sevoflurane with oxygen (Fi=40%)and air, with a MAC value to maintain BIS between 40 and 60. Intraoperative analgesia will be obtained with Remifentanil 0.15-0.25mcg/kg/min. Additional boluses of Cisatracurium (0.02mcg/kg)will be administered as needed during surgery. At the beginning of closure of the peritoneum bolus of morphine (0.1mg/kg)and acetaminophen 1g will be administered. Propofol and remifentanil infusions will be interrupted at the end of wound closure.

Fentanyldrug

In group B anesthesia will be induced by Propofol (2mg/kg), Fentanyl (2mcg/kg)and Cisatracurium (0.15mg/kg). Anesthesia will be maintained by Sevoflurane, oxygen (Fi=40%) and air and boluses of Fentanyl (50mcg). additional boluses of Cisatracurium (0.02mg/kg)will be administered as needed during surgery. At the beginning of closure of the peritoneum acetaminophen 1g will be administered.