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Study on the Use of Low Dose Ketamine After Gastric Bypass and Gastrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02452060
Recruitment Status : Completed
First Posted : May 22, 2015
Results First Posted : March 16, 2020
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
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
 (submitted: March 2, 2020)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 18, 2015)		 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2020)		 Length of Stay During Hospitalization [ Time Frame: 8 days ]
LOS will be recorded from medical record.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2015)		 length of stay during hospitalization [ Time Frame: 8 days ]
LOS will be recorded from medical record.
Current Other Pre-specified Outcome Measures
 (submitted: March 2, 2020)
  • Opioid Usage Per Hour During the PACU Stay Before and After Ketamine Infusion [ Time Frame: 8 Days ]
    Length of stay and opioid usage will be recorded from electronic medical chart
  • Opioid Usage Per Day Throughout the Hospital Stay [ Time Frame: 8 days ]
    recorded from medical chart
  • Time to Out of Bed to Chair (OOB) [ Time Frame: 7 Days ]
    Patient will be asked to record and report the time to OOB
  • Spirometry Use 4 Hours After the Termination of Ketamine Infusion [ Time Frame: 1 day ]
    Spirometry use will be assessed by a study team member to determine whether the patient is meeting the goal set by the surgical team 4 hours after ketamine infusion.
  • Change in Serum Level of IL-1 After Ketamine Infusion [ Time Frame: 1 day ]
    changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.
  • Survey Scores - McGill's Short Form [ Time Frame: Pre-op,Day of Surgery through Post-op Day 8 ]
    Change in survey scores -- McGill's short form
  • Survey Scores - Becks Depression Index (BDI) [ Time Frame: Pre-op,Day of Surgery through Post-op Day 8 ]
    Change in survey scores for Becks Depression Index (BDI)
  • Survey Scores - QoR15 [ Time Frame: Pre-op,Day of Surgery through Post-op Day 8 ]
    Change in scores for Quality of Recovery 15 - QoR15
  • Survey Scores - MADRS [ Time Frame: Pre-op,Day of Surgery through Post-op Day 8 ]
    Change in scores for MADRS
  • Change in Serum Level of IL-6 After Ketamine Infusion [ Time Frame: 1 day ]
    changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.
  • Change in Serum Level of TNF-α After Ketamine Infusion [ Time Frame: 1 day ]
    changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.
  • Change in Serum Level of BDNF After Ketamine Infusion [ Time Frame: 1 day ]
    changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.
Original Other Pre-specified Outcome Measures
 (submitted: May 18, 2015)
  • opioid usage per hour during the PACU stay before and after ketamine infusion [ Time Frame: 8 Days ]
    Length of stay and opioid usage will be recorded from electronic medical chart
  • opioid usage per day throughout the hospital stay [ Time Frame: 8 days ]
    recorded from medical chart
  • time to out of bed to chair (OOB) [ Time Frame: 7 Days ]
    Patient will be asked to record and report the time to OOB
  • Spirometry use 4 hours after the termination of ketamine infusion [ Time Frame: 1 day ]
    Spirometry use will be assessed by a study team member to determine whether the patient is meeting the goal set by the surgical team 4 hours after ketamine infusion.
  • Exploratory secondary outcome measures [ Time Frame: 1 day ]
    changes in serum levels of IL-1, IL6, TNF-α, and BDNF, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.
  • Survey scores - McGill's short form [ Time Frame: Pre-op,Day of Surgery through Post-op Day 8 ]
    Change in survey scores -- McGill's short form
  • Survey Scores - Becks Depression Index (BDI) [ Time Frame: Pre-op,Day of Surgery through Post-op Day 8 ]
    Change in survey scores for Becks Depression Index (BDI)
  • Survey Scores - QoR15 [ Time Frame: Pre-op,Day of Surgery through Post-op Day 8 ]
    Change in scores for Quality of Recovery 15 - QoR15
  • Survey Scores - MADRS [ Time Frame: Pre-op,Day of Surgery through Post-op Day 8 ]
    Change in scores for MADRS
 
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
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Postoperative Depression
Intervention  ICMJE
  • Drug: Ketamine
    0.4mg/kg infusion
    Other Name: ketalar
  • Other: Placebo Comparator
    0.4mg/kg infusion
    Other Name: Saline Infusion
Study Arms  ICMJE
  • Placebo Comparator: treatment/placebo
    saline infusion
    Intervention: Other: Placebo Comparator
  • Experimental: treatment
    ketamine (0.4mg/kg)
    Intervention: Drug: Ketamine
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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2020)		 90
Original Estimated Enrollment  ICMJE
 (submitted: May 18, 2015)		 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:

  1. Adults, >18 years, <65 years, who will undergo gastric bypass or sleeve gastrectomy.

  2. Subject is non-lactating and is either:

    • Not of childbearing potential; or
    • Of childbearing potential but is not pregnant at time of baseline as determined by pre-operative pregnancy testing.
  3. Subject is ASA physical status 1, 2, or 3.
  4. Subject who is deemed medically stable

Exclusion Criteria:

  1. <18 years of age; >65 years of age
  2. Pregnant or breastfeeding
  3. Does not speak or understand English (the study forms used are copy-righted in English)
  4. Cognitively impairment (by history) or clinical signs of altered mental status
  5. History of misuse or abuse of ketamine
  6. History of chest pain or chest pain in the PACU
  7. Use of a medication that interferes with metabolism of ketamine within the last 24 hours
  8. A diagnosis of schizophrenia and/ or a history of chronic antipsychotic medication use
  9. History of head trauma
  10. History of intracranial mass or hemorrhage
  11. History of stroke
  12. History of cardiac arrhythmia
  13. Subject for whom ketamine is contraindicated
  14. Unwillingness to give informed consent according to HIC guidelines
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: Jing Wang, MD, PHD NYU School of Medicine
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