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Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery

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: 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

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Ketamine Drug: Ketamine plus magnesium Other: Placebo Not Applicable

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.

    .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery
Actual Study Start Date : November 2015
Actual Primary Completion Date : March 13, 2019
Actual Study Completion Date : March 13, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ketamine
Ketamine: 0.5 mg/kg IV dose
Drug: Ketamine
Ketamine infusion plus placebo infusion of normal saline

Other: Placebo
2 placebo infusions
Other Name: Normal Saline

Active Comparator: Ketamine plus magnesium
Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV
Drug: Ketamine plus magnesium
Ketamine plus magnesium infusion

Placebo Comparator: Placebo
Placebo (normal saline)
Other: Placebo
2 placebo infusions
Other Name: Normal Saline




Primary Outcome Measures :
  1. Total Hydromorphone Use [ Time Frame: During surgery and 24 hours post-op ]
    Total hydromorphone use in 1st 24 hours post-operatively.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334059


Locations
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United States, Pennsylvania
Milton S.Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Sanjib Adhikary, MB, BS,MD PSHMC College of Medicine
  Study Documents (Full-Text)

Documents provided by Sanjib D Adhikary, Milton S. Hershey Medical Center:
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Responsible Party: Sanjib D Adhikary, Associate professor, Department of Anesthesiology,, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02334059    
Other Study ID Numbers: STUDY00001623
First Posted: January 8, 2015    Key Record Dates
Results First Posted: November 19, 2019
Last Update Posted: June 1, 2020
Last Verified: May 2020
Keywords provided by Sanjib D Adhikary, Milton S. Hershey Medical Center:
opioid sparing
ketamine
obese
magnesium
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action