NCT07411794

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jan 2026Jun 2026

Study Start

First participant enrolled

January 15, 2026

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 9, 2026

Last Update Submit

February 9, 2026

Conditions

Postoperative Delirium

Keywords

postoperative deliriumdexmedetomidinemidazolamcoronary artery by pass

Outcome Measures

Primary Outcomes (1)

  • Delirium

    Presence of delirium according to the CAM-ICU assessment

    Postoperative 24 hours

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

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.

Drug: Intravenous Dexmedetomidine infusion + Standard Anesthesia

Midazolam

ACTIVE COMPARATOR

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.

Drug: intravenous midazolam infusion + Standard anesthesia

Interventions

Intravenous Dexmedetomidine infusion + Standard AnesthesiaDRUG

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.

Dexmedetomidine
intravenous midazolam infusion + Standard anesthesiaDRUG

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.

Midazolam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients scheduled for elective coronary artery bypass graft surgery.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University

Sivas, 58140, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Central Study Contacts

Oğuz Gündoğdu

CONTACT

+905545945469droguzgundogdu@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 17, 2026

Study Start

January 15, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)