A Phase 4 interventional study of Dexmedetomidine 0.6 and Dexmedetomidine 0.3 in Anesthesia, Obesity, Morbid and Dexmedetomidine, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-08-31.
Sponsored by Tanta University · Phase 4, Interventional, and Treatment
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.
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 .
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 90 is above the median of 60 across 590 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Dexmedetomidine 0.6
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.
Drug: Dexmedetomidine 0.3
Patients will receive comparable volume of normal saline (0.9%) 15 minute after endotracheal intubation.
Drug: Saline
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.
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.
Patients received over 10 minutes comparable volume of normal saline (0.9%) 15 min after endotracheal intubation followed by infusion.
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.
Time frame: Intraoperative
Dynamic Lung compliance
Dynamic lung compliance=tidal volume/ (peak airway pressure- Positive end-expiratory pressure).
Time frame: 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
Time frame: 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 %
Time frame: 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
Time frame: 24 hours Postoperatively
Time to first rescue analgesia
Time to first rescue analgesia as morphine consumption was recorded
Time frame: 24 hours Postoperatively
Static lung compliance
Static lung compliance =tidal volume /(plateau pressure - Positive end-expiratory pressure).
Time frame: Intraoperative
Lung compliance
compliance = dynamic compliance at the end of the drug infusion - baseline dynamic compliance.
Time frame: 24 hours
Plateau pressure
Plateau pressure was calculated by increasing end inspiratory pause to 30-40%.
Time frame: Intraoperative
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tanta University