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

December 1, 2014 updated by: Min Su, First Affiliated Hospital of Chongqing Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

132

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • China,Chongqing The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 24 hours after the sixth ECT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
at 24 hours before the first ECT and 24 hours after each ECT
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.
at 30 seconds after each ECT
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.
60 minutes prior to the first ECT and at 40, 80, 110, and 230 minutes after each ECT
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.
at 40 minutes after each ECT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYYYMZ-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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