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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Germano De Cosmo, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01627873
First received: June 21, 2012
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Patients Undergoing Major Abdominal Surgery
Postoperative Confusion
Drug: Remifentanil
Drug: Fentanyl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Screening
Official Title: Effect of Remifentanil on Postoperative Cognitive Function in Patients Undergoing Major Abdominal Surgery

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Rey verbal memory test of words before and after major abdominal surgery [ Time Frame: participants will be followed the day before and after surgery and for the duration of hospital stay, an expected average of 5 days ] [ Designated as safety issue: Yes ]
    In test of Rey to the subject is presented for 5 times the same list of 15 bisyllabic words or trisillabic common use of which he must recall as many as possible within 1 minute; after about 15 minutes the patient, meanwhile distracted by the test , must again try to remember the greatest number possible without a further reading. The maximum possible score of the first phase of the test is an expression of the ability of short term memory of the subject, the result of the test is repeated at a distance of 15 minutes is indicative of its storage capacity, to intermediate term.

  • Stroop Test before and after surgery [ Time Frame: participants will be followed the day before and after surgery and for the duration of hospital stay, an expected average of 5 days ] [ Designated as safety issue: Yes ]
    In the Stroop Test patient is instructed to read a random sequence of adjectives "green", "red", "blue" written in black font, then he refers the colour of a succession of circumferences filled of the three colors above in random order; finally, another random succession of three words "green", "red", "blue" written in three characters of the same colors, but not associated with corresponding adjective. Number of errors that the subject does in reading is an indication of its ability to attention


Secondary Outcome Measures:
  • Quantitative determination of serum pro and anti inflammatory cytokines before and after surgery [ Time Frame: participants will be followed the day before and after surgery and for the duration of hospital stay, an expected average of 5 days ] [ Designated as safety issue: Yes ]
    Blood samples will be made for the quantitative determination of serum cytokines IL-1β, IL-6, IL-8, TNF-α, IL-10 and IL-12. Determinations will be given by Multiplex Elisa method.


Enrollment: 622
Study Start Date: August 2009
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remifentanyl
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: 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.
Active Comparator: 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.
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.

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

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01627873

Locations
Italy
Policlinico Universitario "A.Gemelli"
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Study Director: Germano De Cosmo, Associated Professor Catholic University of the Sacred Heart - Rome
  More Information

Publications:

Responsible Party: Germano De Cosmo, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01627873     History of Changes
Other Study ID Numbers: A/575/2009
Study First Received: June 21, 2012
Last Updated: June 22, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:
Major abdominal surgery
analgesic method
Fentanyl
Remifentanyl
Postoperative cognitive disorder
Pro and anti inflammatory cytokines

Additional relevant MeSH terms:
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Fentanyl
Remifentanil
Cisatracurium
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Central Nervous System Depressants
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Hypnotics and Sedatives
Neuromuscular Blocking Agents
Neuromuscular Agents

ClinicalTrials.gov processed this record on July 23, 2014