Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery
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ClinicalTrials.gov Identifier: NCT02334059 |
Recruitment Status :
Completed
First Posted : January 8, 2015
Results First Posted : November 19, 2019
Last Update Posted : June 1, 2020
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Sponsor:
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
Sanjib D Adhikary, Milton S. Hershey Medical Center
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Tracking Information | ||||
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First Submitted Date ICMJE | December 23, 2014 | |||
First Posted Date ICMJE | January 8, 2015 | |||
Results First Submitted Date ICMJE | July 15, 2019 | |||
Results First Posted Date ICMJE | November 19, 2019 | |||
Last Update Posted Date | June 1, 2020 | |||
Actual Study Start Date ICMJE | November 2015 | |||
Actual Primary Completion Date | March 13, 2019 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Total Hydromorphone Use [ Time Frame: During surgery and 24 hours post-op ] Total hydromorphone use in 1st 24 hours post-operatively.
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Original Primary Outcome Measures ICMJE |
Total Hydromorphone use [ Time Frame: 1st 24 hours post-op ] Total hydromorphone use in 1st 24 hours post-operatively.
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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 | Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery | |||
Official Title ICMJE | Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery | |||
Brief Summary | Opioid sparing analgesia is extremely important in the post-operative obese population. With more and more obese patients entering the operating room a multi-modal approach to analgesia is crucial. Finding effective alternatives to opioid therapy is the rationale of this proposal. Literature involving ketamine and magnesium in bariatric surgical patients is very sparse. | |||
Detailed Description |
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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, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Obesity | |||
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 |
108 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 13, 2019 | |||
Actual Primary Completion Date | March 13, 2019 (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 80 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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02334059 | |||
Other Study ID Numbers ICMJE | STUDY00001623 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Sanjib D Adhikary, Milton S. Hershey Medical Center | |||
Original Responsible Party | Sajib Adhikary, Milton S. Hershey Medical Center, Associate professor, Department of Anesthesiology, | |||
Current Study Sponsor ICMJE | Milton S. Hershey Medical Center | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Milton S. Hershey Medical Center | |||
Verification Date | May 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |