Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery
1 other identifier
interventional
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Nov 2015
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2014
CompletedFirst Posted
Study publicly available on registry
January 8, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2019
CompletedResults Posted
Study results publicly available
November 19, 2019
CompletedJune 1, 2020
May 1, 2020
3.4 years
December 23, 2014
July 15, 2019
May 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Hydromorphone Use
Total hydromorphone use in 1st 24 hours post-operatively.
During surgery and 24 hours post-op
Secondary Outcomes (2)
Pain Scores Using Verbal Analogue Scale (VAS)
Preoperatively and the 1st 24 hours post-op
Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane
Intraoperative period
Study Arms (3)
Ketamine
ACTIVE COMPARATORKetamine: 0.5 mg/kg IV dose
Ketamine plus magnesium
ACTIVE COMPARATORKetamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV
Placebo
PLACEBO COMPARATORPlacebo (normal saline)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Milton S.Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sanjib D Adhikary
- Organization
- Penn State Health Anesthesiology and Perioperative Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Sanjib Adhikary, MB, BS,MD
PSHMC College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor, Department of Anesthesiology,
Study Record Dates
First Submitted
December 23, 2014
First Posted
January 8, 2015
Study Start
November 1, 2015
Primary Completion
March 13, 2019
Study Completion
March 13, 2019
Last Updated
June 1, 2020
Results First Posted
November 19, 2019
Record last verified: 2020-05