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OpenTrials
Completed

NCT Number: NCT02334059

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Milton S.Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

  • Patient will be identified by surgeon and consented by member of the research team
  • Patient will be randomized to one of three groups on the day of surgery
  • Following securement of the endotracheal tube, the study medication will be administered over 10 minutes via an IV infusion pump.
  • The subject will receive ketamine, ketamine plus magnesium or a placebo.
  • 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.
  • Primary outcome will be the total amount of hydromorphone used in the first 24 hours post-operatively.

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects undergoing laparoscopic sleeve gastrectomy
  • Consenting adults age 18-80
  • ASA II to ASA III
  • Ability to understand and use a PCA
  • Required to be hospitalized for at least 24 hours post-op

Exclusion criteria

  • Patient refusal
  • Chronic opiate use (daily opiate use for >3 months)
  • Chronic Kidney disease (Creatinine>2)
  • Known allergy or adverse effect of ketamine, magnesium or hydromorphone
  • Patients with documented psychiatry (Maniac or MDP) history
  • Patient unable to give informed consent
  • Patient with limited or no English fluency

Treatment and study plan

ketamine

Drug

Ketamine infusion plus placebo infusion of normal saline

Ketamine plus magnesium

Drug

Ketamine plus magnesium infusion

Placebo

Other

2 placebo infusions

Other names: Normal Saline

Primary outcomes

  1. Total Hydromorphone Use

    Time frame: During surgery and 24 hours post-op

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 8, 2015
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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