Dexmedetomidine and Postoperative Cognitive Dysfunction (POCD)

Phase 4

Completed

• Conditions: Postoperative Cognitive Dysfunction; Postoperative Pain
• Interventions: Drug: Dexmedetomidine; Drug: Sevoflurane

• Registration Number: NCT06371638
• Lead Sponsor: Udayana University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-07
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-07
• Status Verified: 2024-04
• Study First Submitted: 2024-04-14
• Study First Submitted QC: 2024-04-14
• Study First Posted: 2024-04-17
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients without POCD	Sevoflurane	MMSE was assessed 24h before surgery, 3 days after surgery, and 30 days before surgery. Subjects is considered to have POCD if the postoperative MMSE score was lower by at least 2 points compared to the preoperative score.
Patients with POCD	Dexmedetomidine	MMSE was assessed 24h before surgery, 3 days after surgery, and 30 days before surgery. Subjects is considered to have POCD if the postoperative MMSE score was lower by at least 2 points compared to the preoperative score.
Patients with POCD	Sevoflurane	MMSE was assessed 24h before surgery, 3 days after surgery, and 30 days before surgery. Subjects is considered to have POCD if the postoperative MMSE score was lower by at least 2 points compared to the preoperative score.
Patients without POCD	Dexmedetomidine	MMSE was assessed 24h before surgery, 3 days after surgery, and 30 days before surgery. Subjects is considered to have POCD if the postoperative MMSE score was lower by at least 2 points compared to the preoperative score.

Primary Outcome Measures

Name	Time	Method
Postoperative cognitive dysfunction (POCD)	30 days postoperative	Assessed by Mini-Mental State Examination (MMSE). Defined if there is a \>= 2 points decrease compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Intraoperative hemodynamics: mean arterial pressure (MAP)	During the course of intraoperative period.	MAP as presented by intraoperative standard monitoring
Intraoperative hemodynamics: heart rate (HR)	During the course of intraoperative period.	HR as presented by intraoperative standard monitoring
Postoperative pain	24 hours postoperative	Assessed by visual analog scale (VAS), minimum value=0 (no pain), maximum=10 (worst pain)

Trial Locations

Locations (1)

Prof. Ngoerah General Hospital; 🇮🇩 Denpasar, Bali, Indonesia