The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy
Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
A multicenter, randomized, controlled, single blind clinical trial on the efficacy and safety
of esmketamine injection in electroconvulsive therapy
Objective to evaluate the efficacy and safety of esmketamine injection in the treatment of
non convulsive electroconvulsive therapy
Participants: Patients with depression receiving MECT
The research drug was esketamine injection
The study design was a multicenter, randomized, single blind, parallel controlled trial
25 mg / kg as the experimental group. The normal saline group was the control group (0.05 ml
/ kg).
The sample size was estimated according to the main efficacy index (remission rate) of this
study. It was assumed that the remission rate of the esketamine injection group was better
than that of the control group. The parameters were set as test level α = 0.05, unilateral, β
= 0.8, the cut-off value was 6%, the experimental group: the control group was 1:1, according
to the results of previous clinical trials and combined with literature, the remission rate
of the control group was 69%, 159 cases in each group, considering the 20% shedding rate, 198
cases in the experimental group and 198 cases in the control group were selected.
1. experimental group
The patients were given intravenous injection of 0.25 mg / kg esketamine, 1.5 mg / kg
propofol and 1 mg / kg succinylcholine in turn. After anesthesia, the patients were
given electroconvulsive therapy
2. In the control group
The patients were given 0.05ml/kg of normal saline, 1.5mg/kg of propofol and 1mg / kg of
succinylcholine. After anesthesia, the patients were given electroconvulsive therapy
Efficacy evaluation 1. Main efficacy indicators
Remission rate of depressive symptoms after MECT treatment
Remission was defined as two consecutive hdrs-24 scores ≤ 10 after receiving MECT
Definition rate of remission rate: the proportion of patients with remission of depressive
symptoms in this group
Phase:
Early Phase 1
Details
Lead Sponsor:
First Affiliated Hospital of Chongqing Medical University