Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 215 for:    Lamotrigine

Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03831854
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

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

Condition or disease Intervention/treatment Phase
Reducing Psychological Side Effects of Ketamine Drug: Lamotrigine 300 MG Drug: Placebo Drug: Ketamine Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Official Title: The Role of Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine Use
Actual Study Start Date : January 24, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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: Ketamine
1mg/kg bolus at induction followed by 5 microgm/kg/min infusion till the end of the surgery

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.
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831854


Contacts
Layout table for location contacts
Contact: Kamal Maheshwari, MD MPH 216-445-4311 maheshk@ccf.org
Contact: Roberta Johnson 216-444-9950 johnsor13@ccf.org

Locations
Layout table for location information
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Roberta Johnson    216-444-9950    johnsor13@ccf.org   
Contact: Mark Mettler    216-445-8281    mettlem@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic

Layout table for additonal information
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03831854     History of Changes
Other Study ID Numbers: 18-952
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make subjects data available to outside researchers

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lamotrigine
Ketamine
Anticonvulsants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Sodium Channel Blockers