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

Catholic University of the Sacred Heart

Status and phase: Completed; Phase 4

Conditions: Patients Undergoing Major Abdominal Surgery; Postoperative Confusion

Treatments: Drug: Remifentanil; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT01627873

A/575/2009

Details and patient eligibility

About

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.

Full 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

Enrollment: 622 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 60 years
• Patients undergoing major abdominal surgery, in General Anesthesia
• ASA class status I-III

Exclusion criteria

• History of allergy to drugs used in the study
• Mini-Mental State Examination (MMSE) value < 26
• Expected duration of anesthesia less than 1 hour and more than 4 hours
• Presence of a cognitive disorder severity of overt such as to prevent collaboration of the patient
• Presence of severe electrolyte disturbances or not controlled bool glucose levels
• History of pain or cerebral vascular disease on the basis of significant carotid or cerebral artery stenosis, to be verified by scanning eco-color doppler
• Habitual use of tranquillizers or other drugs affecting the central nervous system
• Difficulties in the management of the airways, such as to make the necessary changes in anesthesia technique
• Severe hypotension or hypertension or other vascular disorders, particularly thrombotic events or bleeding during surgery or in the perioperative period
• Bleeding that requires blood transfusion
• Medication needs higher or lower than that indicated in the protocol to ensure the depth of hypnosis, indicated by values of BIS targets
• Refusal by the patient

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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622 participants in 2 patient groups

Remifentanyl

Experimental group

Description:

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.

Treatment:

Drug: Remifentanil

Fentanyl

Active Comparator group

Description:

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.

Treatment:

Drug: Fentanyl