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Completed

NCT Number: NCT06371638

Dexmedetomidine and Postoperative Cognitive Dysfunction (POCD)

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.

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Key information

Conditions

Postoperative Cognitive Dysfunction Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Prof. Ngoerah General Hospital

Denpasar, Bali, 80114, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

General anaesthesia for subjects in Group D was maintained by target-controlled infusion (TCI) dexmedetomidine (Dyck mode) with target plasma of 1 ng/ml

Other names: Group D

Sevoflurane

Drug

General anaesthesia for subjects in Group I was maintained by inhalation anaesthesia using sevoflurane at 0.8% concentration.

Other names: Group I

Primary outcomes

  1. Postoperative cognitive dysfunction (POCD)

    Time frame: 48 hours postoperative

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

  2. 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

  1. Intraoperative hemodynamics: mean arterial pressure (MAP)

    Time frame: During the course of intraoperative period.

    MAP as presented by intraoperative standard monitoring

  2. Intraoperative hemodynamics: heart rate (HR)

    Time frame: During the course of intraoperative period.

    HR as presented by intraoperative standard monitoring

  3. Postoperative pain

    Time frame: 1 hour postoperative

    Assessed by visual analog scale (VAS), minimum value=0 (no pain), maximum=10 (worst pain)

  4. Postoperative pain

    Time frame: 12 hours postoperative

    Assessed by visual analog scale (VAS), minimum value=0 (no pain), maximum=10 (worst pain)

  5. Postoperative pain

    Time frame: 24 hours postoperative

    Assessed by visual analog scale (VAS), minimum value=0 (no pain), maximum=10 (worst pain)

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Registry information

Official study title

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

Acronym: CODE-POCD

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2024
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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