Phase 3
Completed N=46
Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine
Reducing Psychological Side Effects of Ketamine
Source: ClinicalTrials.gov NCT03831854 ↗
Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Psychologic Side-effects — 4; 4 score on a scale — p=0.08
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Patient will receive lamotrigine vs. placebo with small sips of water. Lamotrigine reaches peak level 1-4 hours after oral administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Psychologic Side-effects |
4; 4 | 0.08 |
| PRIMARY Number of Patients With Psychologic Disturbances- |
0; 3 | 0.11 |
| SECONDARY Total Opioid Consumption in PACU (mg) |
5; 10 | 0.63 |
| SECONDARY Pain Score in PACU |
4.9; 4.4 | 0.58 |
| SECONDARY Number of Patients Who Had PONV (Postoperative Nausea Vomiting) |
5; 5 | 1.0 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03831854). 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. Informational only — not medical advice.