NCT03831854

Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine

The Role of Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine Use

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-01-24
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2019-02-06
• Last updated: 2021-06-09
• Results posted: 2021-06-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study