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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

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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Impaired Cognition Electroconvulsive Therapy Drug: ketamine and propofol Drug: propofol and normal saline Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: ketamine and propofol
propofol 1.5 mg/kg and ketamine 0.3 mg/kg will be administered to participants separately by intravenous infusion.

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02305394


Contacts
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Contact: Qibin Chen, Master 023-89011061 403497559@qq.com

Locations
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China, Chongqing
China,Chongqing The First Affiliated Hospital of Chongqing Medical University Not yet recruiting
Chongqing, Chongqing, China, 400016
Contact: Su Min, MD    +86-23-89011068    ms89011068@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Chongqing Medical University
Investigators
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Principal Investigator: Su Min First Affiliated Hospital of Chongqing Medical University

Publications:

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Responsible Party: Min Su, The Department of Anesthesia and Pain Medicine, First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT02305394     History of Changes
Other Study ID Numbers: CYYYMZ-006
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014
Keywords provided by Min Su, First Affiliated Hospital of Chongqing Medical University:
ketamine
Electroconvulsive Therapy
Cognitive Function
Additional relevant MeSH terms:
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Depression
Cognitive Dysfunction
Behavioral Symptoms
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Ketamine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action