Evaluation of general body and brain functions in children, adolescents and young adults undergoing electroconvulsive therapy
Not Applicable
- Conditions
- Health Condition 1: F939- Childhood emotional disorder, unspecified
- Registration Number
- CTRI/2021/09/036487
- Lead Sponsor
- ational Institute of Mental Health and Neurosciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
�Children and adolescents (aged less than
18 years) and young adults of age 18 to 24
years (control group) undergoing modified
ECT as part of the management of their
Axis I Psychiatric diagnosis
�Written informed consent from parents and
informed assent from children/adolescents
�Written informed consent from the adult
participants/the relative who is giving
consent for ECT
Exclusion Criteria
�Patients with intracranial pathology,
�Patients with baseline SpO2 of < 92%,
�Baseline HR of <60 beats/min,
�Pre-existing cardiac diseases and cardiac
arrhythmias
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method �To evaluate the effects of ECT on systemic hemodynamics, cerebral oxygenation, and the cerebral electrical activity using PSI in pediatric patients undergoing modified ECT <br/ ><br>�To evaluate autonomic dysfunction due to ECT <br/ ><br>Timepoint: Heart rate, SpO2, NIBP will be recorded every 1 minute <br/ ><br>PSI and rSO2 values will be recorded every 30 seconds until 5 minutes after the ECT stimulus, and at 10 min and 15 min following ECT. <br/ ><br>The autonomic system using ANSiscope will be monitored prior to anesthetic induction and immediately after ECT.
- Secondary Outcome Measures
Name Time Method To compare all the above parameters with a group of controls; patients between the age of 18- 24 years (matched for gender), who are also undergoing ECTTimepoint: Comparison will be made in the above mentioned respective time points.;To determine the incidence of systemic and airway related complications <br/ ><br>Timepoint: During management and observation of the case till discharge to the ward.;To evaluate the effect of ECT on clinical outcome using the CGI and C-GAS assessmentTimepoint: Baseline, after the completion of ECT sessions, one month after during the follow up;To evaluate the seizure duration (both EEG and motor seizure)Timepoint: During the induction of modiifed ECT.