Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/2/2019 |
| Start Date: | January 24, 2019 |
| End Date: | December 2021 |
| Contact: | Kamal Maheshwari, MD MPH |
| Email: | maheshk@ccf.org |
| Phone: | 216-445-4311 |
The Role of Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine Use
Patient will receive lamotrigine vs. placebo with small sips of water. Lamotrigine reaches
peak level 1-4 hours after oral administration.
peak level 1-4 hours after oral administration.
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.
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.
Inclusion Criteria:
- 18 -65 Years of age
- Planned overnight hospital stay
Exclusion Criteria:
- Pregnant and planning to become pregnant
- No known History of seizure
- No known History of Schizophrenia
- No known History of unstable angina
- Patients taking Antiepileptic medications
- Known history of Lamotrigine intake in past.
- Any history of allergic reaction to lamotrigine in the past.
We found this trial at
1
site
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
Click here to add this to my saved trials
