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Clinical Trials/NCT06371638
NCT06371638
Completed
Phase 4

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

Udayana University1 site in 1 country112 target enrollmentJanuary 7, 2024

Overview

Phase
Phase 4
Intervention
Dexmedetomidine
Conditions
Postoperative Cognitive Dysfunction
Sponsor
Udayana University
Enrollment
112
Locations
1
Primary Endpoint
Postoperative cognitive dysfunction (POCD)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 7, 2024
End Date
March 7, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Udayana University
Responsible Party
Principal Investigator
Principal Investigator

Christopher Ryalino, MD

Assistant Professor

Udayana University

Eligibility Criteria

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

Arms & Interventions

Patients with POCD

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.

Intervention: Dexmedetomidine

Patients with POCD

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.

Intervention: Sevoflurane

Patients without POCD

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.

Intervention: Dexmedetomidine

Patients without POCD

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.

Intervention: Sevoflurane

Outcomes

Primary Outcomes

Postoperative cognitive dysfunction (POCD)

Time Frame: 30 days postoperative

Assessed by Mini-Mental State Examination (MMSE). Defined if there is a \>= 2 points decrease compared to baseline.

Secondary Outcomes

  • Intraoperative hemodynamics: mean arterial pressure (MAP)(During the course of intraoperative period.)
  • Intraoperative hemodynamics: heart rate (HR)(During the course of intraoperative period.)
  • Postoperative pain(24 hours postoperative)

Study Sites (1)

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