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

Chongqing Medical University

Status and phase: Unknown; Phase 4

Conditions: Depressive Symptoms; Electroconvulsive Therapy; Impaired Cognition

Treatments: Drug: propofol and normal saline; Drug: ketamine and propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT02305394

CYYYMZ-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups

PK group (ketamine and propofol)

Experimental group

Description:

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.

Treatment:

Drug: ketamine and propofol

P group (propofol group)

Active Comparator group

Description:

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.

Treatment:

Drug: propofol and normal saline