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

Phase 4

• Conditions: Electroconvulsive Therapy; Impaired Cognition; Depressive Symptoms
• Interventions: Drug: ketamine and propofol; Drug: propofol and normal saline

• Registration Number: NCT02305394
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2014-11
• Study First Submitted: 2014-11-19
• Study First Submitted QC: 2014-12-01
• Last Update Submitted: 2014-12-01
• Study First Posted: 2014-12-02
• Last Update Posted: 2014-12-02
• Study Start: 2015-01
• Primary Completion: 2016-12
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PK group (ketamine and propofol)	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.
P group (propofol group)	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.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.

Primary Outcome Measures

Name	Time	Method
Mini-Mental State examination score	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

Name	Time	Method
Mini-Mental State examination score	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)	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	at 30 seconds after each ECT	Seizure duration and Seizure energy index will be recorded by the ECT apparatus.
Brief Psychiatric Rating Scale（BPRS）	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.	at 40 minutes after each ECT	Adverse effects include nausea, vomit, headache, tachycardia and increased blood pressure.

Trial Locations

Locations (1)

China,Chongqing The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China