The Effect of Dexmedetomidine Infusion on Post-operative Cognitive Function and Oxidative Stress in Cardiac Surgery

NCT03054857 | Completed Phase 4 Results DMC

• 1 other identifier: 2558-102
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: The aim of this study was to determine the effect of dexmedetomidine in reducing postoperative cognitive dysfunction (POCD) in cardiac surgical patients which use cardiopulmonary bypass machine (CPB). Materials and Methods: This study was double-blinded, randomized controlled trial. Patients scheduled for elective CPB facilitated cardiac surgery were randomly assigned in two groups, dexmedetomidine group (DEX) or control group. The cognitive tests (MoCA test and Short bless test) were done before the operation, 48 hours, and 7 days postoperatively. POCD was defined as a decline of 1SD of baseline score in any test. Arterial blood sample were analyzed for IL-6, IL-10, TNF-alpha and hs-CRP before induction (T0), after separation from CPB (T1), arrival at ICU (T2) and 24-hour after surgery (T3). Primary outcome was the incidence of POCD and the secondary outcomes were inflammatory response, other postoperative complications, ICU and hospital stay.

Conditions

Oxidative Stress; Cognition Disorders

Outcome Measures

Primary Outcomes (2)

• Numbers of Participants With Postoperative Cognitive Dysfunction (POCD)

  POCD was defined as a decline of 1 standard-deviation (1SD) of baseline score in either MoCA test or short bless test.

  48 hours

• Number of Participants With Postoperative Cognitive Dysfunction (POCD)

  POCD was defined as a decline of 1SD of baseline score in either MoCA test or short bless test.

  7 days

Secondary Outcomes (3)

• Number of Participants With Postoperative Complications

  7 days

• Hospital Stay in Days

  30 days

• ICU Stay in Hours

  7 days

Study Arms (2)

Dex group

EXPERIMENTAL

After skin incision, the Dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.

Drug: Dexmedetomidine

Placebo group

PLACEBO COMPARATOR

The control group received a loading dose and continuous IV infusion of normal saline at the same rate.

Drug: Placebo

Interventions

Dexmedetomidine DRUG

After skin incision, the dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.

Also known as: Dex

Dex group

Placebo DRUG

The control group received a loading dose and continuous IV infusion of normal saline at the same volume and rate as in the dexmedetomidine group

Placebo group

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-III.

You may not qualify if:

• patients who were allergy to medication in the research regimen
• preoperative left ventricular ejection fraction less than 30%
• body mass index more than 35 kg/m2
• preoperative mean arterial pressure less than 60 mmHg
• preoperative heart rate less than 45/min
• patients with impaired renal function (serum creatinine more than 1.5 mg/dl in female and 2 mg/dl in male)
• active liver disease, and who had history of symptomatic cerebrovascular disease
• psychiatric problem and other neurological diseases
• patients who cannot read

Sponsors & Collaborators

• Chulalongkorn University: lead

MeSH Terms

Conditions

Cognition Disorders

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Some missing data of postoperative neurocognitive assessment score leading to inconclusive results of some participants Low incidence of POCD in our samples leading to less reliable results

Results Point of Contact

• Title: Dr.Yada Thongsuk
• Organization: King Chulalongkorn Memorial Hospital

thongsuk.y@hotmail.com

+66817738629

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: February 16, 2017
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 19, 2018
• Results First Posted: June 19, 2018

Record last verified: 2018-05