Clinical trial NCT01627873: Effect of Remifentanil on Postoperative Cognition Function in Patients Undergoing Major Abdominal Surgery
Official title: Effect of Remifentanil on Postoperative Cognitive Function in Patients Undergoing Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients Undergoing Major Abdominal Surgery
Postoperative Confusion
Keywords: Major abdominal surgery
analgesic method
Fentanyl
Remifentanyl
Postoperative cognitive disorder
Pro and anti inflammatory cytokines
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 622
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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

Eligibility 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

Primary outcomes:
measure: Rey verbal memory test of words before and after major abdominal surgery
timeFrame: participants will be followed the day before and after surgery and for the duration of hospital stay, an expected average of 5 days
measure: Stroop Test before and after surgery
timeFrame: participants will be followed the day before and after surgery and for the duration of hospital stay, an expected average of 5 days
Secondary outcomes:
measure: Quantitative determination of serum pro and anti inflammatory cytokines before and after surgery
timeFrame: participants will be followed the day before and after surgery and for the duration of hospital stay, an expected average of 5 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Universitario "A.Gemelli"
Study officials:
affiliation: Catholic University of the Sacred Heart - Rome
name: Germano De Cosmo, Associated Professor
role: STUDY_DIRECTOR
References:
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citation: 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. doi: 10.1017/S0265021507003043. Epub 2007 Nov 16.
citation: 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. doi: 10.1016/s0140-6736(97)07382-0.
citation: 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. doi: 10.1007/BF03027718.
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