Study on the Use of Low Dose Ketamine After Gastric Bypass and Gastrectomy
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ClinicalTrials.gov Identifier: NCT02452060 |
Recruitment Status :
Completed
First Posted : May 22, 2015
Results First Posted : March 16, 2020
Last Update Posted : March 16, 2020
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Sponsor:
NYU Langone Health
Information provided by (Responsible Party):
NYU Langone Health
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Tracking Information | ||||
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First Submitted Date ICMJE | April 16, 2015 | |||
First Posted Date ICMJE | May 22, 2015 | |||
Results First Submitted Date ICMJE | July 12, 2019 | |||
Results First Posted Date ICMJE | March 16, 2020 | |||
Last Update Posted Date | March 16, 2020 | |||
Actual Study Start Date ICMJE | October 2014 | |||
Actual Primary Completion Date | April 13, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change in Pain Scores [ Time Frame: Baseline (DOS) to 7 days (Post Op) ] VAS Scores will be assessed on Day of Surgery (DOS), Post-op Day (POD) 1, 2 and 7. If patients have been discharged, coordinators will contact patient by home.
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Original Primary Outcome Measures ICMJE |
Pain Scores [ Time Frame: 8 days ] VAS Scores will be assessed on Day of Surgery (DOS), Post-op Day (POD) 1, 2 and 7. If patients have been discharged, coordinators will contact patient by home.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
Length of Stay During Hospitalization [ Time Frame: 8 days ] LOS will be recorded from medical record.
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Original Secondary Outcome Measures ICMJE |
length of stay during hospitalization [ Time Frame: 8 days ] LOS will be recorded from medical record.
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | ||||
Brief Title ICMJE | Study on the Use of Low Dose Ketamine After Gastric Bypass and Gastrectomy | |||
Official Title ICMJE | Randomized, Double-blind, Placebo Controlled Study on the Effect of a Single Postoperative Administration of Low Dose Ketamine After Gastric Bypass and Gastrectomy Surgeries | |||
Brief Summary | This is a randomized, double-blind, placebo-controlled, two-arm parallel, single-center study. One hundred subjects (50 in each arm) will be enrolled. Subjects, between the ages 18 and 65, undergoing laparoscopic gastric bypass or sleeve gastrectomy will be recruited and consented during the preadmission visit prior to surgery. | |||
Detailed Description | This is a randomized, double-blind, placebo-controlled, two-arm parallel, single-center study. One hundred subjects (50 in each arm) will be enrolled. Subjects, between the ages 18 and 65, undergoing laparoscopic gastric bypass or sleeve gastrectomy will be recruited and consented during the preadmission visit prior to surgery. Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ketamine (0.4mg/kg) or matching placebo. Both men and women will be recruited, and there is no limitation as to racial and ethnic origin. In the PACU, patients will receive either 0.4mg/kg IV ketamine or placebo. All patients will also receive standard post-anesthetic monitoring and care, as well as routine care after transfer out of the PACU. Patients are followed until the date of discharge, and endpoints (see below) are collected from patient reports as well as from medical charts. During their hospital stay (and once after their discharge from the hospital), patients will fill out five questionnaires which provide estimates of their postoperative pain control, mood and function, and quality of postsurgical recovery. An additional component of the study, which is entirely optional, is to obtain patient serum samples (about two teaspoons) in the operating room and 15 minutes and 4 hours after ketamine infusion. The investigators will use these samples to assess levels of IL-1, IL-6, TNF-α, and BDNF, which are markers for pain. In addition, with patient consent, the investigators will also store serum samples for future research use to measure other cytokines and neurotrophic factors and molecular markers associated with pain and depression. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, 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 * | Wang J, Echevarria GC, Doan L, Ekasumara N, Calvino S, Chae F, Martinez E, Robinson E, Cuff G, Franco L, Muntyan I, Kurian M, Schwack BF, Bedrosian AS, Fielding GA, Ren-Fielding CJ. Effects of a single subanaesthetic dose of ketamine on pain and mood after laparoscopic bariatric surgery: A randomised double-blind placebo controlled study. Eur J Anaesthesiol. 2019 Jan;36(1):16-24. doi: 10.1097/EJA.0000000000000860. | |||
* 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 |
90 | |||
Original Estimated Enrollment ICMJE |
100 | |||
Actual Study Completion Date ICMJE | April 13, 2017 | |||
Actual Primary Completion Date | April 13, 2017 (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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02452060 | |||
Other Study ID Numbers ICMJE | 14-00472 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | NYU Langone Health | |||
Original Responsible Party | Jing Wang, NYU Langone Health, Assistant Professor | |||
Current Study Sponsor ICMJE | NYU Langone Health | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | NYU Langone Health | |||
Verification Date | March 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |