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History of Changes for Study: NCT02334059
Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery
Latest version (submitted May 15, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 5, 2015 None (earliest Version on record)
2 January 7, 2015 Arms and Interventions and Study Status
3 June 27, 2016 Recruitment Status, Study Status, Contacts/Locations, Oversight and Sponsor/Collaborators
4 January 10, 2017 Study Status and Contacts/Locations
5 March 1, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
6 March 13, 2019 Recruitment Status, Study Status and Sponsor/Collaborators
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Results Submission Events
7 November 1, 2019 Outcome Measures, Study Status, Document Section, Results and Study Description
8 December 16, 2019 Study Status and Baseline Characteristics
9 May 15, 2020 Study Status, Outcome Measures
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Study NCT02334059
Submitted Date:  January 5, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: STUDY00001623
Brief Title: Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery
Official Title: Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2015
Overall Status: Not yet recruiting
Study Start: August 2015
Primary Completion: September 2016 [Anticipated]
Study Completion: November 2016 [Anticipated]
First Submitted: December 23, 2014
First Submitted that
Met QC Criteria:
January 5, 2015
First Posted: January 8, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 5, 2015
Last Update Posted: January 8, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Milton S. Hershey Medical Center
Responsible Party: Principal Investigator
Investigator: Sajib Adhikary
Official Title: Associate professor, Department of Anesthesiology,
Affiliation: Milton S. Hershey Medical Center
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Opioid sparing anesthesia 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.

    .

Open or close this module Conditions
Conditions: Obesity
Keywords: opioid sparing
ketamine
obese
magnesium
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 108 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Ketamine
Ketamine: 0.5 mg/kg IV dose
Drug: Ketamine
Ketamine infusion plus placebo infusion of normal saline
Placebo
2 placebo infusions
Other Names:
  • Normal Saline
Drug: Acetaminophen
1 gram IV acetaminophen
Drug: Scopolamine
1mg transdermal patch
Drug: Ondansetron
4 mg IV ondansetron
Drug: Dexamethasone
4 mg IV dexamethasone
Drug: Hydromorphone
Hydromorphone Patient Controlled Analgesia; 0.2 mg IV every six minutes, maximum 2 mg/hour
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
Drug: Acetaminophen
1 gram IV acetaminophen
Drug: Scopolamine
1mg transdermal patch
Drug: Ondansetron
4 mg IV ondansetron
Drug: Dexamethasone
4 mg IV dexamethasone
Drug: Hydromorphone
Hydromorphone Patient Controlled Analgesia; 0.2 mg IV every six minutes, maximum 2 mg/hour
Placebo Comparator: Placebo
Placebo (normal saline)
Placebo
2 placebo infusions
Other Names:
  • Normal Saline
Drug: Acetaminophen
1 gram IV acetaminophen
Drug: Scopolamine
1mg transdermal patch
Drug: Ondansetron
4 mg IV ondansetron
Drug: Dexamethasone
4 mg IV dexamethasone
Drug: Hydromorphone
Hydromorphone Patient Controlled Analgesia; 0.2 mg IV every six minutes, maximum 2 mg/hour
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Total Hydromorphone use
[ Time Frame: 1st 24 hours post-op ]

Total hydromorphone use in 1st 24 hours post-operatively.
Secondary Outcome Measures:
1. 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
2. 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
3. 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
4. Intraoperative fentanyl use
[ Time Frame: Intraoperative period ]

Total amount of fentanyl used by the anesthetic provider in the operating room will be recorded.
5. Intraoperative minimum alveolar concentration (MAC) of desflurane
[ Time Frame: Intraoperative period ]

The average MAC concentration of desflurane will be recorded during the intraoperative period
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Christie Mulvey
Telephone: 7175317988
Email: cmulvey@hmc.psu.edu
Study Officials: Sanjib Adhikary, MB, BS,MD
Principal Investigator
PSHMC College of Medicine
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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