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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 August 2016 |
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Main ID: |
NCT02213159 |
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Date of registration:
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08/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery
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Scientific title:
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Intraoperative Dexmedetomidine Versus Morphine for Postoperative Analgesia After Laparoscopic Bariatric Surgery |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02213159 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Sahar Siddik, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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AUBMC |
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Name:
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Carine Zeeni, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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AUBMC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Body Mass Index > 40 kg/m2 or BMI > 35 kg/m2 with comorbid conditions such as
hypertension, diabetes or sleep apnea
- American Society of Anesthesiologists class I or II
- Undergoing laparoscopic sleeve gastrectomy bariatric surgery
Exclusion Criteria:
- Allergy to morphine or its derivatives
- Allergy to a-2 adrenergic agonists
- weight over 180 kg
- history of uncontrolled hypertension
- heart block greater than first degree
- prolonged QT interval
- clinically significant neurologic, cardiovascular, renal, hepatic, or
gastrointestinal diseases
- received an opioid analgesic medication within a 24 h period prior to surgery
- history of alcohol, drug abuse or chronic opioid intake
- history of psychiatric disorder
- pregnant or breastfeeding.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obesity
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Sleep Apnea
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Diabetes
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Hypertension
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Intervention(s)
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Drug: Dexmedetomidine
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Drug: Morphine
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Primary Outcome(s)
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Total dose of morphine consumed in Post Anesthesia Care Unit (PACU)
[Time Frame: At discharge from the PACU]
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Secondary Outcome(s)
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incidence of pruritus
[Time Frame: in the PACU]
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overall satisfaction at one month
[Time Frame: one month after surgery]
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Quality of Recovery (QoR-40) score at 24 hours
[Time Frame: at 24 hours]
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incidence of respiratory complications
[Time Frame: in the PACU]
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incidence of vomiting or retching
[Time Frame: in the PACU]
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total morphine consumption at 24 hours
[Time Frame: at 24 hours]
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NRS for nausea
[Time Frame: in the PACU]
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Numeric Rating Scale (NRS) for Pain
[Time Frame: in the PACU and at 24 hours]
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Time to first morphine requirement in PACU
[Time Frame: in the PACU]
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time to discharge readiness in PACU
[Time Frame: in the PACU]
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Secondary ID(s)
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ANES.CZ.2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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