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Completed

NCT Number: NCT03831854

Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine

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

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Key information

Conditions

Reducing Psychological Side Effects of Ketamine

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lamotrigine 300 MG

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).

Other names: Lamictal 300 mg

Placebo

Drug

300 mg of oral Placebo

ketamine

Drug

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

Primary outcomes

  1. Psychologic Side-effects

    Time frame: in PACU (up to 90 minutes after ketamine infusion)

    The primary outcome of psychologic side-effects was measured in PACU (up to 90 minutes after ketamine infusion). This included four key items of the Brief Psychiatric Rating Scale (BPRS) corresponding to positive symptoms of schizophrenia: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content. Each symptom is rated 1-7 ( 1 = not present, 2 = very mild, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, 7 = extremely severe ), and, therefore, the total score as the primary outcome based on four key items of BPRS will be between 4 (best score) and 28 (worst score).

  2. Number of Patients With Psychologic Disturbances-

    Time frame: Up to 90 minutes of PACU arrival

    The psychologic side-effects were measured in PACU (up to 90 minutes after ketamine infusion). This included four key items of the Brief Psychiatric Rating Scale (BPRS) corresponding to positive symptoms of schizophrenia: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content. Each symptom is rated 1-7 ( 1 = not present, 2 = very mild, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, 7 = extremely severe ), and, therefore, the total score as the primary outcome based on four key items of BPRS will be between 4 (best score) and 28 (worst score). Patients who had a total score of 4 (all symptoms not present) were determined as not having psychologic disturbance and patients who had a total score of > 4 (having any symptoms present) were determined as having psychologic disturbance.

Secondary outcomes

  1. Total Opioid Consumption in PACU (mg)

    Time frame: from entry to PACU to leaving PACU, up to 4 hours

    Total cumulative opioid use (total IV morphine equivalents) in postoperative anesthesia care unit (PACU)

  2. Pain Score in PACU

    Time frame: from entry to PACU to leaving PACU

    Pain score was scaled from 0-10 where 0 means no pain and 10 means most pain. The time-weighted average of pain scores was used if the pain score was measured multiple times.

  3. Number of Patients Who Had PONV (Postoperative Nausea Vomiting)

    Time frame: after surgery up to discharge

    PONV was measured through Postoperative Nursing Progress Record, where nausea vomiting severity was recorded as 0 (none), 1 (mild), 2 (moderate), 3 (severe). Patients whose score was 0 were determined as not having PONV and patients whose score was positive were determined as having PONV.

Other outcomes

  1. Daily Average Opioid Use During Hospital Stay

    Time frame: from admission up to discharge

    The average daily opioid use (mg) during the hospital stay.

  2. Opioid Related Side-effects (ORSDS)-POD1

    Time frame: postoperative day 1

    ORSDS is a 4 point-scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness for 12 opioid-related side effects, with a score of each item ranging from 0 to 4 where higher scores mean more side effects). The final ORSDS score is the average of all 12 scores from those 12 items, ranging from 0 to 4 where a higher score means worse outcome. This one measure ORSDS at postoperative day 1

  3. Opioid Related Side-effects (ORSDS)-POD2

    Time frame: postoperative day 2

    ORSDS is a 4 point-scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness for 12 opioid-related side effects, with a score of each item ranging from 0 to 4 where higher scores mean more side effects). The final ORSDS score is the average of all 12 scores from those 12 items, ranging from 0 to 4 where a higher score means a worse outcome. This one measure ORSDS at postoperative day 2.

  4. PACU Length of Stay, Hours

    Time frame: in PACU

    Hours spent in PACU (Postanesthesia Care Unit).

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2019
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.