Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine

Brief Summary

Patient will receive lamotrigine vs. placebo with small sips of water. Lamotrigine reaches peak level 1-4 hours after oral administration.

Intervention / Treatment

  • Drug: Lamotrigine 300 MG
  • Drug: Placebo
  • Drug: Ketamine

Condition or Disease

  • Reducing Psychological Side Effects of Ketamine

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 18 Years to 65 Years   (Adult, Older Adult)
Enrollment: 50 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Jan 24, 2019
Primary Completion: Dec 20, 2020
Completion Date: Dec 21, 2020
Study First Posted: Feb 06, 2019
Results First Posted: Aug 31, 2020
Last Updated: Apr 08, 2020

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

1:1 randomization without stratification use web-based software (Redcap) before surgery. Allocation will be concealed from the patient, the nurse, the operating room team. Both patient and the operating room team will be blinded to the treatment allocation (double blind).

Standard preoperative care as per anesthesia care team. Patient will receive lamotrigine vs. placebo with small sips of water. Lamotrigine reaches peak level 1-4 hours after oral administration. Single dose lamotrigine is safe and is not associated with rash.

Standard intraoperative care as per the anesthesia care team. All patients will receive Ketamine 1 mg/kg at induction. Ketamine 5mcg/kg/min will be started at induction and stopped at the end of surgery.

Standard postoperative care as per PACU team. The psychologic side-effects will be measured using Brief Psychiatric Rating Scale (BPRS) using an online tool.

Research fellow will receive standardized training in administering BPRS from Dr. Amit Anand using structured material. Dr. Anand has used this training for other current research projects.

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 65

This clinical trial is recruiting

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More Details

NCT Number: NCT03831854
Other IDs: 18-952
Study URL: https://ClinicalTrials.gov/show/NCT03831854
Last updated: Jun 17, 2022