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

Condition(s) targeted: Patients Undergoing Major Abdominal Surgery; Postoperative Confusion

Intervention: Remifentanil (Drug); Fentanyl (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Catholic University of the Sacred Heart

Official(s) and/or principal investigator(s):
Germano De Cosmo, Associated Professor, Study Director, Affiliation: Catholic University of the Sacred Heart - Rome

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Screening

Primary outcome:

Rey verbal memory test of words before and after major abdominal surgery

Stroop Test before and after surgery

Secondary outcome: Quantitative determination of serum pro and anti inflammatory cytokines before and after surgery

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

Minimum age: 60 Years. Maximum age: 90 Years. Gender(s): Both.

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

Policlinico Universitario "A.Gemelli", Rome 00168, Italy

Related publications:

Rasmussen LS, Moller JT. Central nervous system dysfunction after anesthesia in the geriatric patient. Anesthesiol Clin North America. 2000 Mar;18(1):59-70, vi. Review.

Dodds C, Allison J. Postoperative cognitive deficit in the elderly surgical patient. Br J Anaesth. 1998 Sep;81(3):449-62. Review.

Rasmussen LS. Perioperative cognitive decline: the extent of the problem. Acta Anaesthesiol Belg. 1999;50(4):199-204. Review.

Parikh SS, Chung F. Postoperative delirium in the elderly. Anesth Analg. 1995 Jun;80(6):1223-32. Review.

Møller JT. Cerebral dysfunction after anaesthesia. Acta Anaesthesiol Scand Suppl. 1997;110:13-6.

Diegeler A, Hirsch R, Schneider F, Schilling LO, Falk V, Rauch T, Mohr FW. Neuromonitoring and neurocognitive outcome in off-pump versus conventional coronary bypass operation. Ann Thorac Surg. 2000 Apr;69(4):1162-6.

Wilson CJ, Finch CE, Cohen HJ. Cytokines and cognition--the case for a head-to-toe inflammatory paradigm. J Am Geriatr Soc. 2002 Dec;50(12):2041-56. Review.

Wan Y, Xu J, Ma D, Zeng Y, Cibelli M, Maze M. Postoperative impairment of cognitive function in rats: a possible role for cytokine-mediated inflammation in the hippocampus. Anesthesiology. 2007 Mar;106(3):436-43.

Buvanendran A, Kroin JS, Berger RA, Hallab NJ, Saha C, Negrescu C, Moric M, Caicedo MS, Tuman KJ. Upregulation of prostaglandin E2 and interleukins in the central nervous system and peripheral tissue during and after surgery in humans. Anesthesiology. 2006 Mar;104(3):403-10. Erratum in: Anesthesiology. 2006 Apr;104(4):900.

Winterhalter M, Brandl K, Rahe-Meyer N, Osthaus A, Hecker H, Hagl C, Adams HA, Piepenbrock S. Endocrine stress response and inflammatory activation during CABG surgery. A randomized trial comparing remifentanil infusion to intermittent fentanyl. Eur J Anaesthesiol. 2008 Apr;25(4):326-35. Epub 2007 Nov 16.

Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. Erratum in: Lancet 1998 Jun 6;351(9117):1742.

Rohan D, Buggy DJ, Crowley S, Ling FK, Gallagher H, Regan C, Moriarty DC. Increased incidence of postoperative cognitive dysfunction 24 hr after minor surgery in the elderly. Can J Anaesth. 2005 Feb;52(2):137-42.

Collie A, Darby DG, Falleti MG, Silbert BS, Maruff P. Determining the extent of cognitive change after coronary surgery: a review of statistical procedures. Ann Thorac Surg. 2002 Jun;73(6):2005-11. Review.

Starting date: August 2009
Last updated: June 22, 2012