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

Tracking Information

• First Submitted Date: December 23, 2014
• First Posted Date: January 8, 2015
• Results First Submitted Date: July 15, 2019
• Results First Posted Date: November 19, 2019
• Last Update Posted Date: June 1, 2020
• Actual Study Start Date: November 2015
• Actual Primary Completion Date: March 13, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 1, 2019)

Total Hydromorphone Use [ Time Frame: During surgery and 24 hours post-op ]

Total hydromorphone use in 1st 24 hours post-operatively.

Original Primary Outcome Measures (submitted: January 5, 2015)

Total Hydromorphone Use [ Time Frame: 1st 24 hours post-op ]

Total hydromorphone use in 1st 24 hours post-operatively.

Current Secondary Outcome Measures (submitted: May 15, 2020)

• 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.
• 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.

Original Secondary Outcome Measures (submitted: January 5, 2015)

• Pain Scores Using Visual Analogue Scale (VAS) [ Time Frame: 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
• Sedation scores using Ramsey Sedation Scale [ Time Frame: 1st 24 hours post-op ]
  Sedation will be measure using a Ramsey sedation scale upon arrival to the PACU and every 4 hours until 24 hours post-op
• Nausea Scores using Likert Scale [ Time Frame: 1st 24 hours post-op ]
  Nausea scores will be taken using a Likert scale: none, mild, moderate, severe. Scored at arrival to PACU and every 4 hours after until 24 hours post-op
• Intraoperative fentanyl use [ Time Frame: Intraoperative period ]
  Total amount of fentanyl used by the anesthetic provider in the operating room will be recorded.
• Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane [ Time Frame: Intraoperative period ]
  The average MAC concentration of desflurane will be recorded during the intraoperative period

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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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• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Obesity

Intervention

• Drug: Ketamine
  Ketamine infusion plus placebo infusion of normal saline
• Drug: Ketamine plus magnesium
  Ketamine plus magnesium infusion
• Other: Placebo
  2 placebo infusions
  Other Name: Normal Saline

Study Arms

• Active Comparator: Ketamine
  Ketamine: 0.5 mg/kg IV dose
  Interventions:

  • Drug: Ketamine
  • Other: Placebo
• Active Comparator: Ketamine plus magnesium
  Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV
  Intervention: Drug: Ketamine plus magnesium
• Placebo Comparator: Placebo
  Placebo (normal saline)
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 5, 2015): 108
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 13, 2019
• Actual Primary Completion Date: March 13, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02334059
• Other Study ID Numbers: STUDY00001623
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sanjib D Adhikary, Milton S. Hershey Medical Center
• Study Sponsor: Milton S. Hershey Medical Center
• Collaborators: Not Provided

Investigators

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

• PRS Account: Milton S. Hershey Medical Center
• Verification Date: May 2020