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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01627873
• Date of registration: 21/06/2012
• Prospective Registration: No
• Primary sponsor: Catholic University of the Sacred Heart
• Public title: Effect of Remifentanil on Postoperative Cognition Function in Patients Undergoing Major Abdominal Surgery
• Scientific title: Effect of Remifentanil on Postoperative Cognitive Function in Patients Undergoing Major Abdominal Surgery
• Date of first enrolment: August 2009
• Target sample size: 622
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01627873
• 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
• Phase: Phase 4

Countries of recruitment

Italy

Contacts

• Name: Germano De Cosmo, Associated Professor
• Affiliation: Catholic University of the Sacred Heart - Rome

Key inclusion & exclusion 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



Age minimum: 60 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Patients Undergoing Major Abdominal Surgery

Postoperative Confusion

Intervention(s)

Drug: Fentanyl

Drug: Remifentanil

Primary Outcome(s)

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]

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]

Secondary Outcome(s)

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]

Secondary ID(s)

A/575/2009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors