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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Ketamine plus magnesium
Placebo
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring opioid sparing, ketamine, obese, magnesium

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Milton S.Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Ketamine

Ketamine plus magnesium

Placebo

Arm Description

Ketamine: 0.5 mg/kg IV dose

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

Placebo (normal saline)

Outcomes

Primary Outcome Measures

Total Hydromorphone Use
Total hydromorphone use in 1st 24 hours post-operatively.

Secondary Outcome Measures

Pain Scores Using Verbal Analogue Scale (VAS)
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
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.

Full Information

First Posted
December 23, 2014
Last Updated
May 15, 2020
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02334059
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
March 13, 2019 (Actual)
Study Completion Date
March 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Patient will be identified by surgeon and consented by member of the research team Patient will be randomized to one of three groups on the day of surgery Following securement of the endotracheal tube, the study medication will be administered over 10 minutes via an IV infusion pump. The subject will receive ketamine, ketamine plus magnesium or a placebo. 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. Primary outcome will be the total amount of hydromorphone used in the first 24 hours post-operatively. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
opioid sparing, ketamine, obese, magnesium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
Ketamine: 0.5 mg/kg IV dose
Arm Title
Ketamine plus magnesium
Arm Type
Active Comparator
Arm Description
Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (normal saline)
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Ketamine infusion plus placebo infusion of normal saline
Intervention Type
Drug
Intervention Name(s)
Ketamine plus magnesium
Intervention Description
Ketamine plus magnesium infusion
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal Saline
Intervention Description
2 placebo infusions
Primary Outcome Measure Information:
Title
Total Hydromorphone Use
Description
Total hydromorphone use in 1st 24 hours post-operatively.
Time Frame
During surgery and 24 hours post-op
Secondary Outcome Measure Information:
Title
Pain Scores Using Verbal Analogue Scale (VAS)
Description
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.
Time Frame
Preoperatively and the 1st 24 hours post-op
Title
Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane
Description
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.
Time Frame
Intraoperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects undergoing laparoscopic sleeve gastrectomy Consenting adults age 18-80 ASA II to ASA III Ability to understand and use a PCA Required to be hospitalized for at least 24 hours post-op Exclusion Criteria: Patient refusal Chronic opiate use (daily opiate use for >3 months) Chronic Kidney disease (Creatinine>2) Known allergy or adverse effect of ketamine, magnesium or hydromorphone Patients with documented psychiatry (Maniac or MDP) history Patient unable to give informed consent Patient with limited or no English fluency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjib Adhikary, MB, BS,MD
Organizational Affiliation
PSHMC College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Milton S.Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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

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