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Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine

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ClinicalTrials.gov Identifier: NCT03831854
Recruitment Status : Completed
First Posted : February 6, 2019
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE December 3, 2018
First Posted Date  ICMJE February 6, 2019
Last Update Posted Date March 4, 2021
Actual Study Start Date  ICMJE January 24, 2019
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • Change in the psychologic side-effects of conceptual with low dose ketamine administration in surgical patients. [ Time Frame: Up to 90 minutes of PACU arrival ]
    The outcomes measure is a rating scale ( 1-7) for multiple question in BPRS which assess Conceptual disorganization.
  • Change in the psychologic side-effects of hallucinatory behavior with low dose ketamine administration in surgical patients. [ Time Frame: Up to 90 minutes of PACU arrival ]
    The outcomes measure is a rating scale ( 1-7) for multiple question in BPRS which assess hallucinatory behavior.
  • Change in the psychologic side-effects of suspiciousness with low dose ketamine administration in surgical patients. [ Time Frame: Up to 90 minutes of PACU arrival ]
    The outcomes measure is a rating scale ( 1-7) for multiple question in BPRS which assess suspiciousness.
  • Change in the psychologic side-effects of unusual thought content with low dose ketamine administration in surgical patients. [ Time Frame: Up to 90 minutes of PACU arrival ]
    The outcomes measure is a rating scale ( 1-7) for multiple question in BPRS which assess unusual thought content.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • Opioid use in PACU [ Time Frame: Up to 90 minutes of PACU arrival ]
    Assuming log-normal distribution of PACU opioid consumption (in IV morphine equivalent), we will evaluate the percent difference in geometric mean IV morphine equivalent dose between the two randomized groups using t-test on the log-transformed data. To evaluate the difference in mean PACU pain scores (in VRS scale) we will first summarize the pain scores (in VRS scale) by computing PACU time weighted average (TWA) pain score for each patient. Then we will use a t-test to assess the exposure effect on the TWA pain scores. Binary PONV outcome will be compared between two study groups using chi-square test.
  • Pain scores in PACU: numeric rating scale [ Time Frame: Up to 90 minutes of PACU arrival ]
    Using the numeric rating scale ( 0-10) to evaluate the PACU pain scores (in VRS scale) we will first summarize the pain scores (in VRS scale) by computing PACU time weighted average (TWA) pain score for each patient.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine
Official Title  ICMJE The Role of Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine Use
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomization without stratification
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
The Pharmacy will know the treatment
Primary Purpose: Prevention
Condition  ICMJE Reducing Psychological Side Effects of Ketamine
Intervention  ICMJE
  • 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).
    Other Name: Lamictal 300 mg
  • Drug: Placebo
    300 mg of oral Placebo
  • Drug: Ketamine
    1mg/kg bolus at induction followed by 5 microgm/kg/min infusion till the end of the surgery
Study Arms  ICMJE
  • Active Comparator: 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.
    Interventions:
    • Drug: Lamotrigine 300 MG
    • Drug: Ketamine
  • Placebo Comparator: 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.
    Interventions:
    • Drug: Placebo
    • Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2021)
46
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2019)
50
Actual Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03831854
Other Study ID Numbers  ICMJE 18-952
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to make subjects data available to outside researchers
Responsible Party The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Cleveland Clinic
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP