Dexmedetomidine and Postoperative Cognitive Dysfunction (POCD)

Postoperative Pain Clinical Trial

— CODE-POCD  

Official title:

Continuous Dexmedetomidine Infusion Reduces Postoperative Cognitive Dysfunction and Postoperative Pain in Patients Undergoing Laparatomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06371638
• Other study ID #: 2024-01
• Status: Completed
• Phase: Phase 4
• Start date: January 7, 2024
• Est. completion date: March 7, 2024

Study information

• Verified date: April 2024
• Source: Udayana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative cognitive dysfunction (POCD) affects all age groups and can lead to increased morbidity and more extended hospital stays. Dexmedetomidine reduces POCD by inhibiting the increase in proinflammatory cytokines IL-6 and TNF-α, and its anti-inflammatory activity contributes to its protective effect. Previous studies found that dexmedetomidine reduced POCD incidence in non-cardiac and cardiac surgery. Therefore, the goal of this study was to specifically investigate if using TCI dexmedetomidine to maintain anaesthesia in laparotomy surgeries reduces the incidence of POCD compared to inhalation anaesthesia by sevoflurane.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 7, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Aged >= 18 years old

• Scheduled for laparatomy surgery

Exclusion Criteria:

• history of allergies to anaesthetic drugs

• impaired consciousness

• neurocognitive disorder

• psychiatric disorder

• mental disorder

• cerebrovascular disorders

• sick sinus syndrome

• hypoalbuminemia

• massive bleeding

• liver disease

• kidney diseases.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Pain, Postoperative
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction
• Postoperative Pain

Intervention

Drug:
• Dexmedetomidine
General anaesthesia for subjects in Group D was maintained by target-controlled infusion (TCI) dexmedetomidine (Dyck mode) with target plasma of 1 ng/ml
• Sevoflurane
General anaesthesia for subjects in Group I was maintained by inhalation anaesthesia using sevoflurane at 0.8% concentration.

Locations

Country	Name	City	State
Indonesia	Prof. Ngoerah General Hospital	Denpasar	Bali

Sponsors (1)

Lead Sponsor	Collaborator
Udayana University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative cognitive dysfunction (POCD)	Assessed by Mini-Mental State Examination (MMSE). Defined if there is a >= 2 points decrease compared to baseline.	48 hours postoperative
Primary	Postoperative cognitive dysfunction (POCD)	Assessed by Mini-Mental State Examination (MMSE). Defined if there is a >= 2 points decrease compared to baseline.	30 days postoperative
Secondary	Intraoperative hemodynamics: mean arterial pressure (MAP)	MAP as presented by intraoperative standard monitoring	During the course of intraoperative period.
Secondary	Intraoperative hemodynamics: heart rate (HR)	HR as presented by intraoperative standard monitoring	During the course of intraoperative period.
Secondary	Postoperative pain	Assessed by visual analog scale (VAS), minimum value=0 (no pain), maximum=10 (worst pain)	1 hour postoperative
Secondary	Postoperative pain	Assessed by visual analog scale (VAS), minimum value=0 (no pain), maximum=10 (worst pain)	12 hours postoperative
Secondary	Postoperative pain	Assessed by visual analog scale (VAS), minimum value=0 (no pain), maximum=10 (worst pain)	24 hours postoperative