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Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine

NCT03831854 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-06-09

Study results available
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Summary

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

Conditions

  • Reducing Psychological Side Effects of Ketamine

Interventions

DRUG

Lamotrigine 300 MG

300 mg of oral Lamotrigine. One of the key studies in this area was reported at the Society of Neuroscience meeting in 1997 and later published in the Archives of General Psychiatry. This study reported that, in healthy subjects 300 mg oral lamotrigine significantly decreased ketamine-induced perceptual abnormalities as assessed by the Clinician-Administered Dissociative States Scale (P\<.001).31 Furthermore lamotrigine increased the immediate mood-elevating effects of ketamine (P\<.05).

DRUG

Placebo

300 mg of oral Placebo

DRUG

Ketamine

1mg/kg bolus at induction followed by 5 microgram/kg/min infusion till the end of the surgery

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-24
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03831854 on ClinicalTrials.gov