Drug UseNCT06355960
Effect of Dexmedetomidine on Oxygenation and Lung Mechanics
A study testing GROUP Dexmedetomidine, GROUP B and GROUP C in people with Drug Use and Dexmedetomidine, run by Cairo University at 1 site in Egypt.
Trial summary
Dexmedetomidine is a selective α -2 agonist widely used in anesthesia for its sympatholytic, sedative and analgesic effects . Favorable respiratory effects in animals , and in selected human patient groups have been reported when using this agent .we investigated the effects of different doses of dexmedetomidine… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Use, Dexmedetomidine
- What is being tested?
- GROUP Dexmedetomidine, GROUP B and GROUP C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 May 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Morbidly obese patients with restrictive lung disease ASA I AND II laparoscopic sleeve gastrectomy
Who cannot join
- history of heart failure history of cardiac arrhythmias severe liver or kidney impairment. Patients with forced expiratory volume in 1 sec (FEV1)/ FVC < 70%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Does of Dexmedetomidine on Oxygenation and Lung Mechanics
Dexmedetomidine is a selective α -2 agonist widely used in anesthesia for its sympatholytic, sedative and analgesic effects . Favorable respiratory effects in animals , and in selected human patient groups have been reported when using this agent .we investigated the effects of different doses of dexmedetomidine infusion on oxygenation
- Conditions
- Drug Use, Dexmedetomidine
- Being tested
- GROUP Dexmedetomidine, GROUP B, GROUP C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GROUP DexmedetomidineDrug
Dexmedetomidine (Precedex) loadings of 1 μg/kg , then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation .
GROUP BDrug
Dexmedetomidine (Precedex) loadings of 0.5 μg/kg , then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation .
GROUP CDrug
Dexmedetomidine (Precedex) loadings of 0.25 μg/kg, then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation .
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | Dexmedetomidine (Precedex) loadings of 1 μg/kg than continuously at a rate of 0.2 μg/(kg/h) till the end of the operation . Receives: Drug: GROUP Dexmedetomidine |
| group B | Active comparator | Dexmedetomidine (Precedex) loadings of 0.5 μg/kg then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation . Receives: Drug: GROUP B |
| group C | Active comparator | Dexmedetomidine (Precedex) loadings of 0.25 μg/kg(group C) then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation . Receives: Drug: GROUP C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation by the end study
PaO2/Fraction of inspired oxygen
Measured: UP TO 6 HOURE
Secondary outcomes (3)
Intraoperative dynamic lung compliance
tidal volume/ (peak airway pressure -PEEP)
Measured: up to 6 hours
Intraoperative static lung compliance
Tidal volume/ (plateau pressure - PEEP)
Measured: UP TO 6 HOURE
Physiological dead space
1.14 (PaCO2-EtCO2)/ PaCO2-0.005
Measured: UP TO 6HOURE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug UseStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Samir Wahdan, Cairo University
- Investigators
- Amr s wahdan, MD, Principal investigator, Cairo university , Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355960
- Sponsor's protocol ID
- 2024-853
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: still working
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Does of Dexmedetomidine on Oxygenation and Lung Mechanics
- ClinicalTrials.gov ID
- NCT06355960
- Acronym / sponsor ID
- 2024-853
- Conditions
- Drug Use, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 10 Apr 2024 (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.
Dexmedetomidine is a selective α -2 agonist widely used in anesthesia for its sympatholytic, sedative and analgesic effects . Favorable respiratory effects in animals , and in selected human patient groups have been reported when using this agent .we investigated the effects of different doses of dexmedetomidine infusion on oxygenation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: GROUP DexmedetomidineDexmedetomidine (Precedex) loadings of 1 μg/kg than continuously at a rate of 0.2 μg/(kg/h) till the end of the operation . |
| group B | Active comparator | Drug: GROUP BDexmedetomidine (Precedex) loadings of 0.5 μg/kg then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation . |
| group C | Active comparator | Drug: GROUP CDexmedetomidine (Precedex) loadings of 0.25 μg/kg(group C) then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Morbidly obese patients with restrictive lung disease ASA I AND II laparoscopic sleeve gastrectomy
Key exclusion criteria (1 listed)
- history of heart failure history of cardiac arrhythmias severe liver or kidney impairment. Patients with forced expiratory volume in 1 sec (FEV1)/ FVC < 70%
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 DexmedetomidineDexmedetomidine (Precedex) loadings of 1 μg/kg , then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation . | Drug | group A |
| GROUP BDexmedetomidine (Precedex) loadings of 0.5 μg/kg , then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation . | Drug | group B |
| GROUP CDexmedetomidine (Precedex) loadings of 0.25 μg/kg, then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation . | Drug | group C |
Primary outcome
Oxygenation by the end study
Time frame: UP TO 6 HOURE
PaO2/Fraction of inspired oxygen
3 secondary outcomes
Intraoperative dynamic lung compliance
Time frame: up to 6 hours
Intraoperative static lung compliance
Time frame: UP TO 6 HOURE
Physiological dead space
Time frame: UP TO 6HOURE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: Undecided. still working
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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.
Amr s wahdan, MD principal investigator
Cairo university , Cairo, Egypt
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 Dexmedetomidine, GROUP B and GROUP C in people with Drug Use and Dexmedetomidine, run by Cairo 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr S Wahdan, MD (00201001422499, amrwahdan@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation by the end study (time frame: UP TO 6 HOURE). 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 10 Apr 2024.