Phase 4
N=100
The Effect of Dexmedetomidine Infusion on Post-operative Cognitive Function and Oxidative Stress in Cardiac Surgery
Oxidative Stress · Cognition Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03054857 ↗Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Jun 2018
Primary outcome: Primary: Numbers of Participants With Postoperative Cognitive Dysfunction (POCD) — 12; 8 Participants — p=0.289
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexmedetomidine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chulalongkorn University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numbers of Participants With Postoperative Cognitive Dysfunction (POCD) |
12; 8 | 0.289 |
| PRIMARY Number of Participants With Postoperative Cognitive Dysfunction (POCD) |
7; 6 | 0.636 |
| SECONDARY Number of Participants With Postoperative Complications |
0; 1; 0; 1 | — |
| SECONDARY Hospital Stay in Days |
9.367; 10.42 | 0.187 |
| SECONDARY ICU Stay in Hours |
33.79; 38.44 | 0.543 |
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.
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists (ASA) physical status I-III.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03054857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.