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Effect of Subanesthetic Dose of Ketamine Combined With Propofol on Cognitive Function in Depressive Patients Undergoing Electroconvulsive Therapy

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ClinicalTrials.gov Identifier: NCT02305394
Recruitment Status : Unknown
Verified November 2014 by Min Su, First Affiliated Hospital of Chongqing Medical University.
Recruitment status was:  Not yet recruiting
First Posted : December 2, 2014
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Min Su, First Affiliated Hospital of Chongqing Medical University

Tracking Information
First Submitted Date  ICMJE November 19, 2014
First Posted Date  ICMJE December 2, 2014
Last Update Posted Date December 2, 2014
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2014)
Mini-Mental State examination score [ Time Frame: at 24 hours after the sixth ECT ]
Mini-Mental State examination score will be measured at 24 hours after the sixth ECT.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2014)
  • Mini-Mental State examination score [ Time Frame: at 24 hours before the first ECT and 24 hours after each ECT, except the sixth ECT. ]
    Mini-Mental State examination score will be measured at 24 hours before the first ECT and 24 hours after each ECT, except the sixth ECT.
  • Effects on Antidepression (Hamilton Depression Rating Scale(HDRS) [ Time Frame: at 24 hours before the first ECT and 24 hours after each ECT ]
    Effect on antidepression will be measured by 24-item Hamilton Depression Rating Scale(HDRS)
  • Seizure Duration and Seizure Energy Index [ Time Frame: at 30 seconds after each ECT ]
    Seizure duration and Seizure energy index will be recorded by the ECT apparatus.
  • Brief Psychiatric Rating Scale(BPRS) [ Time Frame: 60 minutes prior to the first ECT and at 40, 80, 110, and 230 minutes after each ECT ]
    Brief Psychiatric Rating Scale is related to psychotomimetic side-effect.
  • Adverse Effects include nausea, vomit, headache, tachycardia and increased blood pressure. [ Time Frame: at 40 minutes after each ECT ]
    Adverse effects include nausea, vomit, headache, tachycardia and increased blood pressure.
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 Effect of Subanesthetic Dose of Ketamine Combined With Propofol on Cognitive Function in Depressive Patients Undergoing Electroconvulsive Therapy
Official Title  ICMJE Effect of Subanesthetic Dose of Ketamine Combined With Propofol on Cognitive Function in Depressive Patients Undergoing Electroconvulsive Therapy ---a Randomized Control Double-Blind Clinical Trial
Brief Summary Electroconvulsive therapy (ECT) is an effective treatment for depression compared with the current antidepressant agents,but the most important side effect is cognitive dysfunction. The purpose of this study is to determine whether subanesthetic dose of ketamine combined with propofol is superior to propofol anesthesia alone in improving cognitive function in depressive patients undergoing ECT.
Detailed Description

Depression is one of the most debilitating and widespread illnesses affecting up to 20% of individuals in their lifetime. However, the current antidepressant agents take weeks to work, and fail to help at least 40% of depressed patients. Electroconvulsive therapy (ECT) is a remarkably effective treatment for depression, but its use is limited by cognitive dysfunction.

As a result, it is becoming a clinical problem which need to be settled urgently. Previous clinical study showed that subanesthetic dose of ketamine could play a role in antidepressant effects with safety and minimal positive psychotic symptoms.The investigators also found that subanesthetic dose of ketamine combined with other anesthetics could improve cognitive function in depressive rats receiving electroconvulsive shock (a model for analogy with ECT). Few clinical researches concerned the effects of subanesthetic dose of ketamine combined with propofol anesthesia on cognitive function in patients after ECT, therefore the investigators conduct this randomized controlled double-blind trial. In this study, cognitive function will be rated by Mini-Mental State examination score.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depressive Symptoms
  • Impaired Cognition
  • Electroconvulsive Therapy
Intervention  ICMJE
  • Drug: ketamine and propofol
    propofol 1.5 mg/kg and ketamine 0.3 mg/kg will be administered to participants separately by intravenous infusion.
  • Drug: propofol and normal saline
    propofol 1.5 mg/kg and normal saline [weight(kg)×0.3÷10]ml will be administered to participants separately by intravenous infusion.
Study Arms  ICMJE
  • Experimental: PK group (ketamine and propofol)
    propofol 1.5 mg/kg and ketamine 0.3 mg/kg will be administered to participants separately by intravenous infusion.When patients become unconscious, succinylcholine 1 mg/kg (a muscle relaxant) will be administered intravenously. After 1 minute of succinylcholine infused, ECT will be performed with bitemporal electrode placement using a stimulus dose of 1.0-millisecond pulse width, 60-Hz frequency, 6.0-second stimulus duration, and 0.8-A maximal stimulus intensity.
    Intervention: Drug: ketamine and propofol
  • Active Comparator: P group (propofol group)
    propofol 1.5 mg/kg and normal saline [weight(kg)×0.3÷10]ml will be administered to participants separately by intravenous infusion.When patients become unconscious, succinylcholine 1 mg/kg (a muscle relaxant) will be administered intravenously. After 1 minute of succinylcholine infused, ECT will be performed with bitemporal electrode placement using a stimulus dose of 1.0-millisecond pulse width, 60-Hz frequency, 6.0-second stimulus duration, and 0.8-A maximal stimulus intensity.
    Intervention: Drug: propofol and normal saline
Publications *

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 1, 2014)
132
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. diagnosed with moderate or severe depression according to Diagnostic and Statistical Manual of Mental Disorders
  2. aged from 18 to 65 years old

Exclusion Criteria:

  1. cerebrovascular malformation, arterial aneurysm, hypertension, or glaucoma;
  2. classification of American Society of Anesthesiologists physical status score IV or V;
  3. complications such as respiratory disease, cardiovascular disease, intracranial hypertension, cerebral vascular disorder;
  4. presence of a foreign body such as pacemaker, intracranial electrode, and clips;
  5. history of seizures;
  6. history of drug abuse;
  7. concomitant presence of a mental disorder;
  8. pregnancy;
  9. history of serious adverse effects related to anesthetics;
  10. refusal to consent for the study, or refusal to undergo one single ECT during the first week of therapy.
  11. hyperthyreosis
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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02305394
Other Study ID Numbers  ICMJE CYYYMZ-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Min Su, First Affiliated Hospital of Chongqing Medical University
Study Sponsor  ICMJE First Affiliated Hospital of Chongqing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Su Min First Affiliated Hospital of Chongqing Medical University
PRS Account First Affiliated Hospital of Chongqing Medical University
Verification Date November 2014

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