DexmedetomidineNCT07066605
The Effect of Dexmedetomidine on Agitation During Weaning From Mechanical Ventilation
A study testing Group A (Dexmedetomidine Group) in people with Dexmedetomidine, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of dexmedetomidine on the level of agitation during the weaning process from mechanical ventilation in critically ill patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dexmedetomidine
- What is being tested?
- Group A (Dexmedetomidine Group)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jun 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ICU patients (≥18 years).
- On mechanical ventilation ≥24 hours.
- Clinically ready for weaning.
- Agitation score RASS ≥ +1 during spontaneous breathing trial.
- Intubation for at least 4 days: 2 weeks.
Who cannot join
- Known hypersensitivity to dexmedetomidine.
- Hemodynamic instability (HR < 50 bpm or MAP < 60 mmHg).
- Neurological impairment affecting level of consciousness.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Al-haddad A Mousa, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Magdy M Amin, Professor, 01090801900
About this study
Official title: The Effect of Dexmedetomidine on Agitation During Weaning From Mechanical Ventilation in Critically Ill Patients"
This study aims to evaluate the effect of dexmedetomidine on the level of agitation during the weaning process from mechanical ventilation in critically ill patients.
- Conditions
- Dexmedetomidine
- Being tested
- Group A (Dexmedetomidine Group), Group B (Control Group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (Dexmedetomidine Group)Drug
patients will receive dexmedetomidine infusion starting at 0.2 mcg/kg/hr.
Group B (Control Group)Drug
patients will receive standard ICU sedation protocol without dexmedetomidine (e.g., fentanyl)
| Study group | Role | What they receive |
|---|---|---|
| Group A (Dexmedetomidine Group) | Active comparator | patients will receive dexmedetomidine infusion starting at 0.2 mcg/kg/hr. Receives: Drug: Group A (Dexmedetomidine Group) |
| Group B (Control Group) | Placebo comparator | patients will receive standard ICU sedation protocol without dexmedetomidine (e.g., fentanyl) Receives: Drug: Group B (Control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Dexmedetomidine on Agitation During Weaning from Mechanical Ventilation
Richmond Agitation-Sedation Scale
Measured: every half an hour for two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start13 Jun 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Sohag 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Ayman Hussien, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066605
- Sponsor's protocol ID
- Soh-Med-25-6---17MS
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Riker RR, Shehabi Y, Bokesch PM, Ceraso D, Wisemandle W, Koura F, Whitten P, Margolis BD, Byrne DW, Ely EW, Rocha MG; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009 Feb 4;301(5):489-99. doi: 10.1001/jama.2009.56. Epub 2009 Feb 2.
PubMed 19188334Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
PubMed 30113379Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on Agitation During Weaning From Mechanical Ventilation in Critically Ill Patients"
- ClinicalTrials.gov ID
- NCT07066605
- Acronym / sponsor ID
- Soh-Med-25-6---17MS
- Conditions
- Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 Jul 2025 (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.
This study aims to evaluate the effect of dexmedetomidine on the level of agitation during the weaning process from mechanical ventilation in critically ill patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Dexmedetomidine Group) | Active comparator | Drug: Group A (Dexmedetomidine Group)patients will receive dexmedetomidine infusion starting at 0.2 mcg/kg/hr. |
| Group B (Control Group) | Placebo comparator | Drug: Group B (Control Group)patients will receive standard ICU sedation protocol without dexmedetomidine (e.g., fentanyl) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult ICU patients (≥18 years).
- On mechanical ventilation ≥24 hours.
- Clinically ready for weaning.
- Agitation score RASS ≥ +1 during spontaneous breathing trial.
- Intubation for at least 4 days: 2 weeks.
Key exclusion criteria (4 listed)
- Known hypersensitivity to dexmedetomidine.
- Hemodynamic instability (HR < 50 bpm or MAP < 60 mmHg).
- Neurological impairment affecting level of consciousness.
- Pregnancy or lactation.
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 |
|---|---|---|
| Group A (Dexmedetomidine Group)patients will receive dexmedetomidine infusion starting at 0.2 mcg/kg/hr. | Drug | Group A (Dexmedetomidine Group) |
| Group B (Control Group)patients will receive standard ICU sedation protocol without dexmedetomidine (e.g., fentanyl) | Drug | Group B (Control Group) |
Primary outcome
Effect of Dexmedetomidine on Agitation During Weaning from Mechanical Ventilation
Time frame: every half an hour for two hours
Richmond Agitation-Sedation Scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Background: PubMed 19188334Riker RR, Shehabi Y, Bokesch PM, Ceraso D, Wisemandle W, Koura F, Whitten P, Margolis BD, Byrne DW, Ely EW, Rocha MG; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009 Feb 4;301(5):489-99. doi: 10.1001/jama.2009.56. Epub 2009 Feb 2.
- Background: PubMed 30113379Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
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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.
Al-haddad A Mousa, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A (Dexmedetomidine Group) in people with Dexmedetomidine, run by Sohag 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 Jul 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalia A Hussein, Resident (01017666214, najiza330@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Dexmedetomidine on Agitation During Weaning from Mechanical Ventilation (time frame: every half an hour for two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07066605, which also lists 3 linked publications.
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 15 Jul 2025.