Status:
COMPLETED
Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine
Lead Sponsor:
The Cleveland Clinic
Conditions:
Reducing Psychological Side Effects of Ketamine
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Patient will receive lamotrigine vs. placebo with small sips of water. Lamotrigine reaches peak level 1-4 hours after oral administration.
Detailed Description
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 operati...
Eligibility Criteria
Inclusion
- 18 -65 Years of age
- Planned overnight hospital stay
Exclusion
- 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.
Key Trial Info
Start Date :
January 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03831854
Start Date
January 24 2019
End Date
December 31 2020
Last Update
June 9 2021
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195