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

• ClinicalTrials.gov Identifier: NCT02334059
• Recruitment Status: Completed
• First Posted: January 8, 2015
• Results First Posted: November 19, 2019
• Last Update Posted: June 1, 2020
• Sponsor: Milton S. Hershey Medical Center
• Information provided by (Responsible Party): Sanjib D Adhikary, Milton S. Hershey Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Obesity	Drug: Ketamine; Drug: Ketamine plus magnesium; Other: Placebo	Not Applicable

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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Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery
• Actual Study Start Date: November 2015
• Actual Primary Completion Date: March 13, 2019
• Actual Study Completion Date: March 13, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Ketamine; Ketamine: 0.5 mg/kg IV dose	Drug: Ketamine; Ketamine infusion plus placebo infusion of normal saline; Other: Placebo; 2 placebo infusions; Other Name: Normal Saline
Active Comparator: Ketamine plus magnesium; Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV	Drug: Ketamine plus magnesium; Ketamine plus magnesium infusion
Placebo Comparator: Placebo; Placebo (normal saline)	Other: Placebo; 2 placebo infusions; Other Name: Normal Saline

Outcome Measures

Primary Outcome Measures :

1. Total Hydromorphone Use [ Time Frame: During surgery and 24 hours post-op ]
   Total hydromorphone use in 1st 24 hours post-operatively.

Secondary Outcome Measures :

1. Pain Scores Using Verbal Analogue Scale (VAS) [ Time Frame: Preoperatively and the 1st 24 hours post-op ]
   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.
2. Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane [ Time Frame: Intraoperative period ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Pennsylvania

Milton S.Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Sponsors and Collaborators

Milton S. Hershey Medical Center

Investigators

• Principal Investigator: Sanjib Adhikary, MB, BS,MD; PSHMC College of Medicine

  Study Documents (Full-Text)

Documents provided by Sanjib D Adhikary, Milton S. Hershey Medical Center:

Study Protocol and Statistical Analysis Plan  [PDF] January 11, 2019

More Information

• Responsible Party: Sanjib D Adhikary, Associate professor, Department of Anesthesiology,, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT02334059
• Other Study ID Numbers: STUDY00001623
• First Posted: January 8, 2015
• Results First Posted: November 19, 2019
• Last Update Posted: June 1, 2020
• Last Verified: May 2020

Keywords provided by Sanjib D Adhikary, Milton S. Hershey Medical Center:

opioid sparing; ketamine; obese; magnesium

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Ketamine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action