Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine

NeuroTherapia, Inc.

Status and phase: Completed; Phase 3

Conditions: Reducing Psychological Side Effects of Ketamine

Treatments: Drug: Ketamine; Drug: Lamotrigine 300 MG; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03831854

18-952

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups, including a placebo group

lamotrigine

Active Comparator group

Description:

Patient will receive 300 mg of oral lamotrigine with small sips of water to reduce the psychologic side effects (measured by four key items of Brief Psychiatric Rating Scale: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content) of intraoperative ketamine use.

Treatment:

Drug: Ketamine

Drug: Lamotrigine 300 MG

Placebo

Placebo Comparator group

Description:

Patient will receive oral Placebo with small sips of water, to reduce the psychologic side effects (measured by four key items of Brief Psychiatric Rating Scale: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content) of intraoperative ketamine use.

Treatment:

Drug: Ketamine

Drug: Placebo