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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Control group | Placebo Comparator | Patients will receive comparable volume of normal saline (0.9%) 15 minute after endotracheal intubation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine 0.6 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic Lung compliance | Dynamic lung compliance=tidal volume/ (peak airway pressure- Positive end-expiratory pressure). | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
after the end of study for one year.
The data will be available upon a reasonable request from the corresponding author
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Dexmedetomidine 0.3 | Drug | 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. |
|
| Saline | Drug | Patients received over 10 minutes comparable volume of normal saline (0.9%) 15 min after endotracheal intubation followed by infusion. |
|
| 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 % | 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 | 24 hours Postoperatively |
| Time to first rescue analgesia | Time to first rescue analgesia as morphine consumption was recorded | 24 hours Postoperatively |
| Static lung compliance | Static lung compliance =tidal volume /(plateau pressure - Positive end-expiratory pressure). | Intraoperative |
| Lung compliance | compliance = dynamic compliance at the end of the drug infusion - baseline dynamic compliance. | 24 hours |
| Plateau pressure | Plateau pressure was calculated by increasing end inspiratory pause to 30-40%. | Intraoperative |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |