Postoperative DeliriumNCT07411794
Dexmedetomidine vs Midazolam in Coronary Artery By-pass Surgery
A study testing Intravenous Dexmedetomidine infusion + Standard Anesthesia and intravenous midazolam infusion + Standard anesthesia in people with Postoperative Delirium, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Intravenous Dexmedetomidine infusion + Standard Anesthesia and intravenous midazolam infusion + Standard anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 2 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled for elective coronary artery bypass graft surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University
Sivas, Sivas, 58140
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Delirium
- Being tested
- Intravenous Dexmedetomidine infusion + Standard Anesthesia, intravenous midazolam infusion + Standard anesthesia
- Keywords
- postoperative delirium, dexmedetomidine, midazolam, coronary artery by pass
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: intravenous midazolam infusion + Standard anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
Presence of delirium according to the CAM-ICU assessment
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start15 Jan 2026
- Primary completion26 May 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguz Gundogdu, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411794
- Sponsor's protocol ID
- 2025-06/15
- Status last verified
- Jun 2026
- First submitted
- 9 Feb 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Dexmedetomidine and Midazolam ınfusions With Respect to Postoperative Delirium in Patients Undergoing Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT07411794
- Acronym / sponsor ID
- 2025-06/15
- Conditions
- Postoperative Delirium
- Keywords
- postoperative delirium, dexmedetomidine, midazolam, coronary artery by pass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 26 May 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Intravenous Dexmedetomidine infusion + Standard AnesthesiaFollowing 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. |
| Midazolam | Active comparator | Drug: intravenous midazolam infusion + Standard anesthesiaFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled for elective coronary artery bypass graft surgery.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous Dexmedetomidine infusion + Standard AnesthesiaFollowing 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 | Dexmedetomidine |
| intravenous midazolam infusion + Standard anesthesiaFollowing 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 | Midazolam |
Primary outcome
Delirium
Time frame: Postoperative 24 hours
Presence of delirium according to the CAM-ICU assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous Dexmedetomidine infusion + Standard Anesthesia and intravenous midazolam infusion + Standard anesthesia in people with Postoperative Delirium, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: Postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.