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

NCT ID: NCT02334059

Last Updated: 2020-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-03-13

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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Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ketamine

Ketamine: 0.5 mg/kg IV dose

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

Ketamine infusion plus placebo infusion of normal saline

Placebo

Intervention Type: OTHER

2 placebo infusions

Ketamine plus magnesium

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

Group Type: ACTIVE_COMPARATOR

Ketamine plus magnesium

Intervention Type: DRUG

Ketamine plus magnesium infusion

Placebo

Placebo (normal saline)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

2 placebo infusions

Interventions

Ketamine

Ketamine infusion plus placebo infusion of normal saline

Intervention Type: DRUG

Ketamine plus magnesium

Ketamine plus magnesium infusion

Intervention Type: DRUG

Placebo

2 placebo infusions

Intervention Type: OTHER

Other Intervention Names

Normal Saline

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sanjib D Adhikary

Associate professor, Department of Anesthesiology,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sanjib Adhikary, MB, BS,MD

Role: PRINCIPAL_INVESTIGATOR

PSHMC College of Medicine

Locations

Milton S.Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00001623

Identifier Type: -

Identifier Source: org_study_id