- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411794
Dexmedetomidine vs Midazolam in Coronary Artery By-pass Surgery
A Comparative Evaluation of Dexmedetomidine and Midazolam ınfusions With Respect to Postoperative Delirium in Patients Undergoing Coronary Artery Bypass Grafting
Study Overview
Status
Conditions
Detailed Description
Patients will be allocated into two groups. Those receiving intraoperative dexmedetomidine infusion will constitute Group D (n = 30), while those receiving intraoperative midazolam infusion will constitute Group M (n = 30). Demographic data, including age, sex, and body mass index, will be recorded.
Intraoperative heart rate, mean arterial pressure, peripheral oxygen saturation (SpO₂), bispectral index (BIS), and cerebral oxygenation (RSO₂) values will be documented at predetermined intervals. Changes in partial carbondioxide pressure (pCO₂) levels will also be recorded. Surgical duration, cardiopulmonary bypass time, recovery time, length of intensive care unit stay, and the presence of delirium as assessed by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) will be documented.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sivas
-
Sivas, Sivas, Turkey (Türkiye), 58140
- Sivas Cumhuriyet University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients scheduled for elective coronary artery bypass graft surgery.
Exclusion Criteria:
- Patients with renal disorders,
- Patients with hepatic disorders,
- Patients with neuropsychiatric disorders,
- Patients whom informed consent could not be obtained
- Patients who declined to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Dexmedetomidine
Following the induction of standard general anaesthesia, dexmedetomidine will be administered as a continuous intravenous infusion at a dose of 0.3-0.7 µg/kg/h.
|
Following the induction of standard general anaesthesia, dexmedetomidine will be administered as a continuous intravenous infusion at a dose of 0.3-0.7 µg/kg/h.
|
|
Active Comparator: Midazolam
Following the induction of standard general anaesthesia, midazolam will be administered as a continuous intravenous infusion at a dose of 0.03-0.06
mg/kg/h.
|
Following the induction of standard general anaesthesia, midazolam will be administered as a continuous intravenous infusion at a dose of 0.03-0.06
mg/kg/h.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delirium
Time Frame: Postoperative 24 hours
|
Presence of delirium according to the CAM-ICU assessment
|
Postoperative 24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-06/15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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