Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery
Information source: Milton S. Hershey Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: Ketamine (Drug); Ketamine plus magnesium (Drug); Placebo (Other)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Milton S. Hershey Medical Center Official(s) and/or principal investigator(s):
Sanjib Adhikary, MB, BS,MD, Principal Investigator, Affiliation: PSHMC College of Medicine
Overall contact:
Christie Mulvey, Phone: 7175317988, Email: cmulvey@hmc.psu.edu
Summary
Opioid sparing anesthesia 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.
Clinical Details
Official title: Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Total Hydromorphone use
Secondary outcome: Pain Scores using Visual Analogue Scale (VAS)Sedation scores using Ramsey Sedation Scale Nausea Scores using Likert Scale Intraoperative fentanyl use Intraoperative minimum alveolar concentration (MAC) of desflurane
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.
.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Christie Mulvey, Phone: 7175317988, Email: cmulvey@hmc.psu.edu Additional Information
Starting date: August 2015
Last updated: January 7, 2015
|
