Dexmedetomidine and Postoperative Cognitive Dysfunction (POCD) (CODE-POCD)

Udayana University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Postoperative Cognitive Dysfunction

Treatments: Drug: Dexmedetomidine; Drug: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT06371638

2024-01

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

Patients with POCD

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Drug: Sevoflurane

Patients without POCD

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Drug: Sevoflurane