Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine

NCT ID: NCT03831854

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-24
• Study Completion Date: 2020-12-31

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 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.

Conditions

Reducing Psychological Side Effects of Ketamine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

lamotrigine

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.

Group Type: ACTIVE_COMPARATOR

Lamotrigine 300 MG

Intervention Type: DRUG

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).

Ketamine

Intervention Type: DRUG

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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

300 mg of oral Placebo

Ketamine

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: DRUG

Placebo

300 mg of oral Placebo

Intervention Type: DRUG

Ketamine

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

Intervention Type: DRUG

Other Intervention Names

Lamictal 300 mg

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-952

Identifier Type: -

Identifier Source: org_study_id