Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine
Brief Summary
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
Location
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
Are you interested in participating in this trial or others? We'd love to help.
More Details
NCT Number: | NCT03831854 |
---|---|
Other IDs: | 18-952 |
Study URL: | https://ClinicalTrials.gov/show/NCT03831854 |