Clinical trial NCT02334059: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: opioid sparing
ketamine
obese
magnesium
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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Eligibility 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

Primary outcomes:
measure: Total Hydromorphone Use
timeFrame: During surgery and 24 hours post-op
Secondary outcomes:
measure: Pain Scores Using Verbal Analogue Scale (VAS)
timeFrame: Preoperatively and the 1st 24 hours post-op
measure: Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane
timeFrame: Intraoperative period
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Milton S.Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: PSHMC College of Medicine
name: Sanjib Adhikary, MB, BS,MD
role: PRINCIPAL_INVESTIGATOR
References: