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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014283-19-IT

Enrollment

622

Registered

2009-07-29

Start date

2009-08-04

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly patients with risk of post operative cognitive dysfunction. MedDRA version: 12.0 Level: LLT Classification code 10009845 Term: Cognitive disturbance

Interventions

Trade Name: ULTIVA Pharmaceutical Form: Solution for infusion INN or Proposed INN: Remifentanil Concentration unit: µg/kg microgram(s)/kilogram Concentration type: equal Concentration number: .15- Tr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to investigate the effects of two analgesia methods (continuous remifentanil infusion versus fentanyl boluses) on postoperative cognitive function in patients undergoing major abdominal surgery. In particular to evaluate if there is a correlation between analgesic used and the occurrence of postoperative cognitive dysfunction (POCD).;Secondary Objective: to evaluate if there is a correlation between analgesic used and variation plasma cytokines? levels and between plasma cytokines? levels and POCD (postoperative cognitive dysfunction).;Primary end point(s): The Rey Auditory Verbal Memory Test and the Stroop color-word test at 24 postoperative hours and at 7 postoperative days	—

Measure

Time frame

Main Objective: The aim of the study is to investigate the effects of two analgesia methods (continuous remifentanil infusion versus fentanyl boluses) on postoperative cognitive function in patients undergoing major abdominal surgery. In particular to evaluate if there is a correlation between analgesic used and the occurrence of postoperative cognitive dysfunction (POCD).;Secondary Objective: to evaluate if there is a correlation between analgesic used and variation plasma cytokines? levels and between plasma cytokines? levels and POCD (postoperative cognitive dysfunction).;Primary end point(s): The Rey Auditory Verbal Memory Test and the Stroop color-word test at 24 postoperative hours and at 7 postoperative days

—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026