N/A N=108 Randomized Triple-blind Treatment

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

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT02334059 ↗

Enrolled (actual)

108

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Total Hydromorphone Use — 161.5; 159.6; 195.9; 41.9 mcg/Kg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ketamine (Drug); Ketamine plus magnesium (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Milton S. Hershey Medical Center
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Hydromorphone Use	161.5; 159.6; 195.9; 41.9; 47.8; 47.3	—
SECONDARY Pain Scores Using Verbal Analogue Scale (VAS)	0.41; 0.35; 0.27; 5.78; 6.03; 5.95	—
SECONDARY Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane	4.05; 4.02; 4.34	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02334059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.