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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
Sponsor:
Information provided by (Responsible Party):
Sanjib D Adhikary, Milton S. Hershey Medical Center

Tracking Information
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
 (submitted: November 1, 2019)
Total Hydromorphone Use [ Time Frame: During surgery and 24 hours post-op ]
Total hydromorphone use in 1st 24 hours post-operatively.
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2015)
Total Hydromorphone Use [ Time Frame: 1st 24 hours post-op ]
Total hydromorphone use in 1st 24 hours post-operatively.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2020)
  • Pain Scores Using Verbal Analogue Scale (VAS) [ Time Frame: Preoperatively and the 1st 24 hours post-op ]
    Pain scores using VAS scale will be recorded pre-operatively, in the PACU, and every 4 hours until 24 hours post-op. The VAS is a 10 point scale, where 0 = no pain and 10 = the worst pain a subject has ever felt. The highest value 10, indicates an extreme self reported level of pain.
  • Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane [ Time Frame: Intraoperative period ]
    The average MAC concentration of desflurane will be recorded during the intraoperative period. The Minimum Alveolar Concentration (MAC) of an inhaled anesthetic is the alveolar (or end-expiratory) concentration at which 50% of patients will not show a motor response to a standardized surgical incision.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2015)
  • Pain Scores Using Visual Analogue Scale (VAS) [ Time Frame: 1st 24 hours post-op ]
    Pain scores using VAS scale will be recorded pre-operatively, in the PACU, and every 4 hours until 24 hours post-op
  • Sedation scores using Ramsey Sedation Scale [ Time Frame: 1st 24 hours post-op ]
    Sedation will be measure using a Ramsey sedation scale upon arrival to the PACU and every 4 hours until 24 hours post-op
  • Nausea Scores using Likert Scale [ Time Frame: 1st 24 hours post-op ]
    Nausea scores will be taken using a Likert scale: none, mild, moderate, severe. Scored at arrival to PACU and every 4 hours after until 24 hours post-op
  • Intraoperative fentanyl use [ Time Frame: Intraoperative period ]
    Total amount of fentanyl used by the anesthetic provider in the operating room will be recorded.
  • Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane [ Time Frame: Intraoperative period ]
    The average MAC concentration of desflurane will be recorded during the intraoperative period
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
  1. Patient will be identified by surgeon and consented by member of the research team
  2. Patient will be randomized to one of three groups on the day of surgery
  3. Following securement of the endotracheal tube, the study medication will be administered over 10 minutes via an IV infusion pump.
  4. The subject will receive ketamine, ketamine plus magnesium or a placebo.
  5. Following surgery, the patient will be taken to the post anesthesia care unit (PACU) and set up with standard ASA monitoring as well as end-tidal CO2 via nasal cannula. A hydromorphone patient controlled analgesia (PCA) pump will be set-up by nursing and given to the patient. Standard dosing of 0.2 mg bolus, every 6 minutes with a maximum 2 mg will be the starting dose as is standard for these patients post-operatively.
  6. Primary outcome will be the total amount of hydromorphone used in the first 24 hours post-operatively.

    .

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
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine infusion plus placebo infusion of normal saline
  • Drug: Ketamine plus magnesium
    Ketamine plus magnesium infusion
  • Other: Placebo
    2 placebo infusions
    Other Name: Normal Saline
Study Arms  ICMJE
  • Active Comparator: Ketamine
    Ketamine: 0.5 mg/kg IV dose
    Interventions:
    • Drug: Ketamine
    • Other: Placebo
  • Active Comparator: Ketamine plus magnesium
    Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV
    Intervention: Drug: Ketamine plus magnesium
  • Placebo Comparator: Placebo
    Placebo (normal saline)
    Intervention: Other: Placebo
Publications * Not Provided

*   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: January 5, 2015)
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:

  1. Subjects undergoing laparoscopic sleeve gastrectomy
  2. Consenting adults age 18-80
  3. ASA II to ASA III
  4. Ability to understand and use a PCA
  5. Required to be hospitalized for at least 24 hours post-op

Exclusion Criteria:

  1. Patient refusal
  2. Chronic opiate use (daily opiate use for >3 months)
  3. Chronic Kidney disease (Creatinine>2)
  4. Known allergy or adverse effect of ketamine, magnesium or hydromorphone
  5. Patients with documented psychiatry (Maniac or MDP) history
  6. Patient unable to give informed consent
  7. Patient with limited or no English fluency
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Responsible Party Sanjib D Adhikary, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sanjib Adhikary, MB, BS,MD PSHMC College of Medicine
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