Clinical trial NCT03831854: Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine
Official title: The Role of Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Reducing Psychological Side Effects of Ketamine
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomization without stratification
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Psychologic Side-effects
timeFrame: in PACU (up to 90 minutes after ketamine infusion)
measure: Number of Patients With Psychologic Disturbances-
timeFrame: Up to 90 minutes of PACU arrival
Secondary outcomes:
measure: Total Opioid Consumption in PACU (mg)
timeFrame: from entry to PACU to leaving PACU, up to 4 hours
measure: Pain Score in PACU
timeFrame: from entry to PACU to leaving PACU
measure: Number of Patients Who Had PONV (Postoperative Nausea Vomiting)
timeFrame: after surgery up to discharge
Other outcomes:
measure: Daily Average Opioid Use During Hospital Stay
timeFrame: from admission up to discharge
measure: Opioid Related Side-effects (ORSDS)-POD1
timeFrame: postoperative day 1
measure: Opioid Related Side-effects (ORSDS)-POD2
timeFrame: postoperative day 2
measure: PACU Length of Stay, Hours
timeFrame: in PACU
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References: