Dexmedetomidine vs Midazolam in Coronary Artery By-pass Surgery

June 2, 2026 updated by: Oguz Gundogdu, Cumhuriyet University

A Comparative Evaluation of Dexmedetomidine and Midazolam ınfusions With Respect to Postoperative Delirium in Patients Undergoing Coronary Artery Bypass Grafting

The aim is to compare the incidence of postoperative delirium following coronary artery bypass grafting (CABG) between patients receiving dexmedetomidine and those receiving midazolam infusions.

Study Overview

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

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sivas
      • Sivas, Sivas, Turkey (Türkiye), 58140
        • Sivas Cumhuriyet University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Actual)

May 26, 2026

Study Completion (Actual)

June 2, 2026

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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