AnesthesiaPhase 4NCT06018948
Effect of Two Different Doses of Dexmedetomidine Infusion in Morbidly Obese Patients
A Phase 4 study testing Dexmedetomidine 0.6, Dexmedetomidine 0.3 and Saline in people with Anesthesia and Obesity, Morbid, run by Tanta University at 1 site in Egypt.
Trial summary
Compare the effects of two different doses of dexmedetomidine infusion on oxygenation as a primary outcome and on lung mechanics, quality of recovery and perioperative analgesia as secondary outcomes in morbidly obese patients with restrictive lung disease undergoing abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anesthesia, Obesity, Morbid, Dexmedetomidine
- What is being tested?
- Dexmedetomidine 0.6, Dexmedetomidine 0.3 and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 30 Sep 2021
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body Mass Index above 40 kg/m2 with restrictive lung disease((forced vital capacity) <70% in pre-operative pulmonary function tests), of American Society of anesthesiologists (ASA) physical status II and III.
- Aged 18-50 years.
- Scheduled for abdominal surgery.
Who cannot join
- Patients with Forced expiratory volume1/forced vital capacity<7.
- Uncontrolled cardiac, respiratory, hepatic or renal diseases.
- Allergy to the study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Two Different Doses of Dexmedetomidine Infusion on Oxygenation, Lung Mechanics, and Quality of Recovery in Morbidly Obese Patients: A Prospective Randomized Controlled Study
Compare the effects of two different doses of dexmedetomidine infusion on oxygenation as a primary outcome and on lung mechanics, quality of recovery and perioperative analgesia as secondary outcomes in morbidly obese patients with restrictive lung disease undergoing abdominal surgery.
Read the detailed description
Dexmedetomidine is a selective α2 receptor agonist and has sympatholytic, analgesic, anti-inflammatory and sedative properties. Dexmedetomidine decreased dead space and improved both lung compliance and oxygenation in chronic obstructive pulmonary disease (COPD) patients undergoing lung cancer surgery.
The effects of dexmedetomidine on oxygenation and lung mechanics had been investigated in obstructive lung disease, but there are little information about its effect in morbidly obese patients with restrictive lung disease .
- Conditions
- Anesthesia, Obesity, Morbid, Dexmedetomidine
- Being tested
- Dexmedetomidine 0.6, Dexmedetomidine 0.3, Saline
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine 0.6Drug
Patients received a bolus dose of 1μg/kg Dexmedetomidine, 15 minutes after endotracheal intubation over 10 minutes followed by infusion of 0.6 μg/kg/hr for one hour.
Dexmedetomidine 0.3Drug
Patients received a bolus dose of 1μg/kg Dexmedetomidine, 15 minutes after endotracheal intubation over 10 minutes followed by infusion of 0.3 μg/kg/hr for one hour.
SalineDrug
Patients received over 10 minutes comparable volume of normal saline (0.9%) 15 min after endotracheal intubation followed by infusion.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine 0.6 group | Active comparator | patients will receive a bolus dose of 1µg/kg dexmedetomidine15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.6 mic/kg/hour for one hour. Receives: Drug: Dexmedetomidine 0.6 |
| Dexmedetomidine 0.3group | Active comparator | patients will receive a bolus dose of 1µg/kg dexmedetomidine 15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.3 mic/kg/hour for one hour. Receives: Drug: Dexmedetomidine 0.3 |
| Control group | Placebo comparator | Patients will receive comparable volume of normal saline (0.9%) 15 minute after endotracheal intubation. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative oxygenation
Intraoperative oxygenation was assessed by P/F ratio (Arterial oxygen tension/fraction of inspired oxygen) at baseline and the end of drug infusion.
Measured: Intraoperative
Secondary outcomes (8)
Dynamic Lung compliance
Dynamic lung compliance=tidal volume/ (peak airway pressure- Positive end-expiratory pressure).
Measured: Intraoperative
Post-operative pain
Assessment of post-operative pain by The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme
Measured: 24 hour postoperatively
Dead space (dead space to tidal volume)
Physiological dead space was calculated by Hardman and Aitkenhead equation: (dead space to tidal volume) = 1.14(PaCO2 -EtCO2)/PaCO2- 0.005 dead space (%) = dead space by end of infusion - dead space at the base line / dead space by the end of drug infusion %
Measured: Intraoperative
Quality of recovery score
The Quality of recovery score scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery
Measured: 24 hours Postoperatively
Time to first rescue analgesia
Time to first rescue analgesia as morphine consumption was recorded
Measured: 24 hours Postoperatively
Static lung compliance
Static lung compliance =tidal volume /(plateau pressure - Positive end-expiratory pressure).
Measured: Intraoperative
Lung compliance
compliance = dynamic compliance at the end of the drug infusion - baseline dynamic compliance.
Measured: 24 hours
Plateau pressure
Plateau pressure was calculated by increasing end inspiratory pause to 30-40%.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Sep 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Tawfik, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018948
- Sponsor's protocol ID
- 33360/09/19
- Status last verified
- Aug 2023
- First submitted
- 2 Jul 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Doses of Dexmedetomidine Infusion on Oxygenation, Lung Mechanics, and Quality of Recovery in Morbidly Obese Patients: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06018948
- Acronym / sponsor ID
- 33360/09/19
- Conditions
- Anesthesia, Obesity, Morbid, Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 31 Aug 2023 (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.
Compare the effects of two different doses of dexmedetomidine infusion on oxygenation as a primary outcome and on lung mechanics, quality of recovery and perioperative analgesia as secondary outcomes in morbidly obese patients with restrictive lung disease undergoing abdominal surgery.
Detailed description
Dexmedetomidine is a selective α2 receptor agonist and has sympatholytic, analgesic, anti-inflammatory and sedative properties. Dexmedetomidine decreased dead space and improved both lung compliance and oxygenation in chronic obstructive pulmonary disease (COPD) patients undergoing lung cancer surgery.
The effects of dexmedetomidine on oxygenation and lung mechanics had been investigated in obstructive lung disease, but there are little information about its effect in morbidly obese patients with restrictive lung disease .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine 0.6 group | Active comparator | Drug: Dexmedetomidine 0.6patients will receive a bolus dose of 1µg/kg dexmedetomidine15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.6 mic/kg/hour for one hour. |
| Dexmedetomidine 0.3group | Active comparator | Drug: Dexmedetomidine 0.3patients will receive a bolus dose of 1µg/kg dexmedetomidine 15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.3 mic/kg/hour for one hour. |
| Control group | Placebo comparator | Drug: SalinePatients will receive comparable volume of normal saline (0.9%) 15 minute after endotracheal intubation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body Mass Index above 40 kg/m2 with restrictive lung disease((forced vital capacity) <70% in pre-operative pulmonary function tests), of American Society of anesthesiologists (ASA) physical status II and III.
- Aged 18-50 years.
- Scheduled for abdominal surgery.
Key exclusion criteria (3 listed)
- Patients with Forced expiratory volume1/forced vital capacity<7.
- Uncontrolled cardiac, respiratory, hepatic or renal diseases.
- Allergy to the study drug
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 0.6Patients received a bolus dose of 1μg/kg Dexmedetomidine, 15 minutes after endotracheal intubation over 10 minutes followed by infusion of 0.6 μg/kg/hr for one hour. | Drug | Dexmedetomidine 0.6 group |
| Dexmedetomidine 0.3Patients received a bolus dose of 1μg/kg Dexmedetomidine, 15 minutes after endotracheal intubation over 10 minutes followed by infusion of 0.3 μg/kg/hr for one hour. | Drug | Dexmedetomidine 0.3group |
| SalinePatients received over 10 minutes comparable volume of normal saline (0.9%) 15 min after endotracheal intubation followed by infusion. | Drug | Control group |
Primary outcome
Intraoperative oxygenation
Time frame: Intraoperative
Intraoperative oxygenation was assessed by P/F ratio (Arterial oxygen tension/fraction of inspired oxygen) at baseline and the end of drug infusion.
8 secondary outcomes
Dynamic Lung compliance
Time frame: Intraoperative
Post-operative pain
Time frame: 24 hour postoperatively
Dead space (dead space to tidal volume)
Time frame: Intraoperative
Quality of recovery score
Time frame: 24 hours Postoperatively
Time to first rescue analgesia
Time frame: 24 hours Postoperatively
Static lung compliance
Time frame: Intraoperative
Lung compliance
Time frame: 24 hours
Plateau pressure
Time frame: Intraoperative
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 31 Aug 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Phase 4 study testing Dexmedetomidine 0.6, Dexmedetomidine 0.3 and Saline in people with Anesthesia and Obesity, Morbid, run by Tanta 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 3 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 31 Aug 2023. 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.
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?
Intraoperative oxygenation (time frame: Intraoperative). 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 31 Aug 2023.