Post Operative DeleriumPhase 4NCT07475156
The Effect of Dexmedetomidine Infusion Alone Versus the Combination of Dexmedetomidine and Melatonin on Reduction of Post-operative Delirium (POD) After Open Brain Surgeries
A Phase 4 study testing Dexmedetomidine (DEX) and Melatonin in people with Post Operative Delerium, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to illuminate the effect of combination of dexmedetomidine and oral melatonin versus the use of dexmedetomidine infusion alone on the improving of post-operative delirium (POD) on patients undergoing open brain surgeries. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Post Operative Delerium
- What is being tested?
- Dexmedetomidine (DEX) and Melatonin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Feb 2026
- Phase
- Phase 4
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 30 - 60 years
- Sex: Both sexes
- Patients with open space occupying lesions or hematoma.
Who cannot join
- Refusal of the patient to give written informed consent.
- History of allergy to the medications used in the study.
- Psychiatric disorder.
- Any form of drug addiction.
- Patients receiving any anti-psychotic medications.
- History of previous brain insult (Ischemic or haemorrhagic infarctions).
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- Pre-operative dementia.
- History of malignant hyperthermia
- Patient's suffering from bradycardia
- Patient's suffering from hypotension
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to illuminate the effect of combination of dexmedetomidine and oral melatonin versus the use of dexmedetomidine infusion alone on the improving of post-operative delirium (POD) on patients undergoing open brain surgeries.
Read the detailed description
Study Population: Patients undergoing open brain surgeries will be randomly assigned into one of the following groups using computer generated codes and opaque sealed envelopes:
- Group A will receive Dexmedetomidine IV Infusion at rate of (0.5 μg/kg/hr) in addition to oral placebo tablets.
- Group B will receive Dexmedetomidine IV Infusion at rate of (0.5 μg/kg/hr) in addition to oral Melatonin (3 mg/tablet).
- Study Procedures:
- Preoperative settings:
All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation.
- Intraoperative settings:
As the patient is taken into the operating room, electrocardiography (ECG), non-invasive blood pressure (NIBP), pulse oximetry will be used, and IV line will be inserted.
Baseline parameters such as systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), and oxygen saturation (SpO2) will be recorded.
For all patients, anaesthesia will be induced using Propofol (2 mg/kg IV), Fentanyl (2 μg/kg IV), then patient will be intubated facilitated with Rocuronium (0.5 mg/kg IV) and the patient will be maintained on Isoflurane (1.2 - 1.5 MAC).
A central venous catheter would be inserted as well as an arterial line for invasive blood pressure monitoring.
End-tidal CO2 will be maintained between 25 and 30 mmHg. Fluids would be infused according to the patient's body weight with Ringer acetate through peripheral venous catheter and a fluid chart would be recorded.
Patients will receive Morphine (2.5-5 mg q3-4hr PRN, infused over 4-5 minutes). The study medications will be prepared by the local pharmacy in the form of Dexmedetomidine (4 μg/ml) in a 50 mL syringe. Melatonin tablets (3 mg/tablet) would be also provided as well as placebo tablets. Then will be handled to the anaesthesiologist in charge of the patient who will be blinded to the nature of the medications used and study medications would be started 15 minutes before the end of surgical procedure.
- Postoperative settings:
After extubation, patients will be taken to the ICU. During the transfer to and on arrival vital data (Blood pressure, heart rate and saturation) will be measured and recorded.
The intensivist following up the patient will be blinded to the groups. Assessment of POD will be done after extubation and every 8 hours. The screening tool used to diagnose POD includes the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
- Measurements
Primary outcome:
The incidence of POD after open brain surgeries. Secondary outcome
- Time from extubation till discharge from ICU.
- Incidence of postoperative nausea and vomiting (PONV).
- Conditions
- Post Operative Delerium
- Being tested
- Dexmedetomidine (DEX), Melatonin
- Keywords
- Post operative delerium, Dexmedetomidine, Melatonin, Open brain surgery, Combination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine (DEX)Drug
Dexmedetomidine IV Infusion at rate of (0.5 μg/kg/hr)
MelatoninDrug
Orall Melatonin (3 mg/tablet)
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Dexmedetomidine alone Receives: Drug: Dexmedetomidine (DEX) |
| Combination Group | Active comparator | Combination of Dexmedetomidine \& Melatonin Receives: Drug: Dexmedetomidine (DEX); Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of POD
Through calculation of CAM-ICU Score \& RASS score of patient
Measured: Perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Aug 2025
- Primary completion15 Jan 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative DeleriumStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475156
- Sponsor's protocol ID
- FMASU M S20/2026
- Status last verified
- Mar 2026
- First submitted
- 12 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine Infusion Alone Versus the Combination of Dexmedetomidine and Melatonin on Reduction of Post-operative Delirium (POD) After Open Brain Surgeries
- ClinicalTrials.gov ID
- NCT07475156
- Acronym / sponsor ID
- FMASU M S20/2026
- Conditions
- Post Operative Delerium
- Keywords
- Post operative delerium, Dexmedetomidine, Melatonin, Open brain surgery, Combination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 16 Mar 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 of this study is to illuminate the effect of combination of dexmedetomidine and oral melatonin versus the use of dexmedetomidine infusion alone on the improving of post-operative delirium (POD) on patients undergoing open brain surgeries.
Detailed description
Study Population: Patients undergoing open brain surgeries will be randomly assigned into one of the following groups using computer generated codes and opaque sealed envelopes:
- Group A will receive Dexmedetomidine IV Infusion at rate of (0.5 μg/kg/hr) in addition to oral placebo tablets.
- Group B will receive Dexmedetomidine IV Infusion at rate of (0.5 μg/kg/hr) in addition to oral Melatonin (3 mg/tablet).
- Study Procedures:
- Preoperative settings:
All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation.
- Intraoperative settings:
As the patient is taken into the operating room, electrocardiography (ECG), non-invasive blood pressure (NIBP), pulse oximetry will be used, and IV line will be inserted.
Baseline parameters such as systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), and oxygen saturation (SpO2) will be recorded.
For all patients, anaesthesia will be induced using Propofol (2 mg/kg IV), Fentanyl (2 μg/kg IV), then patient will be intubated facilitated with Rocuronium (0.5 mg/kg IV) and the patient will be maintained on Isoflurane (1.2 - 1.5 MAC).
A central venous catheter would be inserted as well as an arterial line for invasive blood pressure monitoring.
End-tidal CO2 will be maintained between 25 and 30 mmHg. Fluids would be infused according to the patient's body weight with Ringer acetate through peripheral venous catheter and a fluid chart would be recorded.
Patients will receive Morphine (2.5-5 mg q3-4hr PRN, infused over 4-5 minutes). The study medications will be prepared by the local pharmacy in the form of Dexmedetomidine (4 μg/ml) in a 50 mL syringe. Melatonin tablets (3 mg/tablet) would be also provided as well as placebo tablets. Then will be handled to the anaesthesiologist in charge of the patient who will be blinded to the nature of the medications used and study medications would be started 15 minutes before the end of surgical procedure.
- Postoperative settings:
After extubation, patients will be taken to the ICU. During the transfer to and on arrival vital data (Blood pressure, heart rate and saturation) will be measured and recorded.
The intensivist following up the patient will be blinded to the groups. Assessment of POD will be done after extubation and every 8 hours. The screening tool used to diagnose POD includes the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
- Measurements
Primary outcome:
The incidence of POD after open brain surgeries. Secondary outcome
- Time from extubation till discharge from ICU.
- Incidence of postoperative nausea and vomiting (PONV).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Dexmedetomidine (DEX)Dexmedetomidine alone |
| Combination Group | Active comparator | Drug: Dexmedetomidine (DEX), Drug: MelatoninCombination of Dexmedetomidine \& Melatonin |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 30 - 60 years
- Sex: Both sexes
- Patients with open space occupying lesions or hematoma.
Key exclusion criteria (10 listed)
- Refusal of the patient to give written informed consent.
- History of allergy to the medications used in the study.
- Psychiatric disorder.
- Any form of drug addiction.
- Patients receiving any anti-psychotic medications.
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 |
|---|---|---|
| Dexmedetomidine (DEX)Dexmedetomidine IV Infusion at rate of (0.5 μg/kg/hr) | Drug | Combination Group, Control Group |
| MelatoninOrall Melatonin (3 mg/tablet) | Drug | Combination Group |
Primary outcome
The incidence of POD
Time frame: Perioperatively
Through calculation of CAM-ICU Score \& RASS score of patient
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 16 Mar 2026.
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Post Operative Delerium, Post Operative Cognitive Dysfunction
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 Phase 4 study testing Dexmedetomidine (DEX) and Melatonin in people with Post Operative Delerium, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 10 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 16 Mar 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The incidence of POD (time frame: Perioperatively). 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 16 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.