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

Penn State Health

Status: Completed

Conditions: Obesity

Treatments: Drug: Ketamine; Other: Placebo; Drug: Ketamine plus magnesium

Study type: Interventional

Funder types: Other

Identifiers

NCT02334059

STUDY00001623

Details and patient eligibility

About

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.

Full 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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Enrollment: 108 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 3 patient groups, including a placebo group

Ketamine

Active Comparator group

Description:

Ketamine: 0.5 mg/kg IV dose

Treatment:

Drug: Ketamine

Other: Placebo

Ketamine plus magnesium

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine plus magnesium

Placebo

Placebo Comparator group

Description:

Placebo (normal saline)

Treatment:

Other: Placebo