Effect of remifentanil on postoperative cognitive function in patients undergoing major abdominal surgery - ND

• Conditions: Elderly patients with risk of post operative cognitive dysfunction.; MedDRA version: 12.0Level: LLTClassification code 10009845Term: Cognitive disturbance

• Registration Number: EUCTR2009-014283-19-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- patients more than 60 years old, ASA (American Society of Anaesthesiologists) I-III, elective major abdominal surgery
- informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

patient?s refusal, Mini Mental State Examination<26, anaesthesia duration lesser than 1 hour and more than 4 hours, patients with cognitive dysfunction or psychiatric disorder or any contraindications to the self-administration of drugs (i.e. inability to understand PCA (patient controlled analgesia), a history of alcohol abuse or of drugs acting on central nervous system, presence of electrolyte or glycemic disorder, cerebral vascular disease, difficult airway management, hypotensive or hypertensive intra-operative episodes, massive blood loos, pharmacological requirements higher or lower than that indicated.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified