Opioid Free Anesthesia in Bariatric Surgery
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ClinicalTrials.gov Identifier: NCT03507634 |
Recruitment Status :
Completed
First Posted : April 25, 2018
Last Update Posted : September 29, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | April 12, 2018 | ||||
First Posted Date ICMJE | April 25, 2018 | ||||
Last Update Posted Date | September 29, 2020 | ||||
Actual Study Start Date ICMJE | April 11, 2018 | ||||
Actual Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Postoperative pain score for 48 hours [ Time Frame: 48 hours postoperative ] Measure the pain score using the Visual Analogue Scale (VAS), The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The score ranges from 0 to 100 mm. A higher score indicates greater pain intensity. The distribution pain is the following:no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).Postoperative pain will be measured using Verbal Analogue Scale (VAS) at 0, 1, 2, 4, 6, 12, 18, and 24 and every 6 hours up to 48 hours post surgery.
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Original Primary Outcome Measures ICMJE |
Postoperative pain score [ Time Frame: 48 hours postoperative ] Measure the pain score using the Visual Analogue Scale (VAS), The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The score ranges from 0 to 100 mm. A higher score indicates greater pain intensity. The distribution pain is the following:no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).Postoperative pain will be measured using Verbal Analogue Scale (VAS) at 0, 1, 2, 4, 6, 12, 18, and 24 hours to be repeated every 6 hours thereafter up to 48 hours post surgery
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Opioid Free Anesthesia in Bariatric Surgery | ||||
Official Title ICMJE | Opioid Free Anesthesia in Bariatric Surgery: A Prospective, Double-blinded, Randomized, Controlled Clinical Trial | ||||
Brief Summary | This study compares the intraoperative opioid free anesthesia approach in laparoscopic bariatric surgery to a conventional opioid- based anesthesia. Half of participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine | ||||
Detailed Description | Since optimal analgesia for the obese patients undergoing bariatric surgeries has always been challenging, and knowing the comorbidities and physiological changes in this population, use of opioid-sparing agents during anesthesia has attracted substantial research.the use of opioids in the perioperative period in obese patients is associated with an increased risk of complications . They are especially more sensitive to the respiratory depressant effect of opioids , thus any analgesic alternative without further compromising airway tone would be a desirable choice. Dexmedetomidine is a selective alpha-two adrenergic receptor agonist that has antinociceptive, analgesic and sedative properties, without compromising airway tone and reflexes . Lidocaine, a local anesthetic that has been shown to be an effective multimodal strategy to minimize postoperative pain was evaluated in one study involving obese patients undergoing bariatric surgery. Its usage was associated with an improved quality of recovery compared to placebo . |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
80 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | June 30, 2020 | ||||
Actual Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Lebanon | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03507634 | ||||
Other Study ID Numbers ICMJE | LAUMCRH.HB2.28/Mar/2018 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Hanane Barakat, Lebanese American University | ||||
Study Sponsor ICMJE | Lebanese American University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Lebanese American University | ||||
Verification Date | September 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |