DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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. .


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017