Dexmedetomidine and Postoperative Cognitive Dysfunction (POCD)

NCT06371638 | Completed Phase 4

• 1 other identifier: 2024-01
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction; Postoperative Pain

Keywords

postoperative cognitive complications; dexmedetomidine; pain; hemodynamics

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• 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

  1 hour postoperative

• Postoperative pain

  12 hours postoperative

• Postoperative pain

  24 hours postoperative

Study Arms (2)

Patients with POCD

EXPERIMENTAL

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.

Drug: Dexmedetomidine; Drug: Sevoflurane

Patients without POCD

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine; Drug: Sevoflurane

Interventions

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

Also known as: Group D

Patients with POCD; Patients without POCD

Sevoflurane DRUG

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

Also known as: Group I

Patients with POCD; Patients without POCD

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \>= 18 years old
• Scheduled for laparatomy surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Prof. Ngoerah General Hospital

Denpasar, Bali, 80114, Indonesia

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications; Pain, Postoperative; Pain

Interventions

Dexmedetomidine; Sevoflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: April 17, 2024
• Study Start: January 7, 2024
• Primary Completion: March 1, 2024
• Study Completion: March 7, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Start: once study is published Until: 1-year after publication

Locations

ID (1)