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

NCT01627873 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 622

Last updated 2012-06-26

No results posted yet for this study

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.

Conditions

  • Patients Undergoing Major Abdominal Surgery
  • Postoperative Confusion

Interventions

DRUG

Remifentanil

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.

DRUG

Fentanyl

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.

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Germano De Cosmo, Associated Professor · Catholic University of the Sacred Heart - Rome

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-07-31
Completion
2011-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT01627873 on ClinicalTrials.gov