NCT01627873

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 622 (actual)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. In particular, whether there is a correlation between type of anesthesia and the appearance of postoperative cognitive disorder (POCD), including type of anesthesia and levels of pro and anti inflammatory cytokines and investigate whether there is an association between presence or absence of POCD and cytokines levels

Conditions

• Patients Undergoing Major Abdominal Surgery
• Postoperative Confusion

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-07-01
• Completion: 2011-12-01
• First posted: 2012-06-26
• Last updated: 2012-06-26

Locations

1 site across 1 country: Italy