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Randomised controlled trial to determine the effect of prophylactic dexmedetomidine on the incidence and duration of post electroconvulsive therapy delirium

Not Applicable
Conditions
Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders
Registration Number
CTRI/2023/06/053541
Lead Sponsor
Kasturba Medical College Manipal
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.American Society of Anaesthesiologists Physical Status Classification I and II patients

2.Age between 18-65 undergoing ECT

Exclusion Criteria

1.American Society of Anaesthesiologists Physical Status Classification III and IV patients

2.Patients with pre-existing liver disorder

3.Patients with pre-existing renal disorder

4.Patients with pre-existing cardiac disorder

5.Patients with heart rate less than 60 bpm

6.Patients with blood pressure less than 90/60 mm of Hg

7.Patients with organic brain disease

8.Patients who undergo ECT under sedation

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
â?¢To compare the incidence of Post ECT delirium in patients receiving prophylactic Dexmedetomidine infusion with a control groupTimepoint: Begins at 10 minutes after seizure activity has ended. The patient will then be assessed for delirium up to a total of 5 times at an interval of 10 minutes. The heart rate & mean arterial pressure (MAP) of the patient will be monitored during Dexmedetomidine infusion and post ECT every 5 minutes up to 50 minutes. <br/ ><br>The delirium will be measured from 10 minutes after the ECT upto 50 minutes after ECT at an interval of 10 minutes each. <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
1.To compare the duration of Post ECT delirium in patients receiving prophylactic Dexmedetomidine infusion with a control groupTimepoint: Begins at 10 minutes after seizure activity has ended. The patient will then be assessed for delirium up to a total of 5 times at an interval of 10 minutes. It will be measured from 10 minutes after the ECT upto 50 minutes after ECT at an interval of 10 minutes each.;2.To compare the effect of prophylactic Dexmedetomidine infusion in controlling the hyperdynamic changes in patients receiving ECT with a control groupTimepoint: The heart rate & mean arterial pressure (MAP) of the patient will be monitored during Dexmedetomidine infusion & post ECT every 5 minutes up to 50 minutes post ECT.;3.To assess the adverse effects of Dexmedetomidine in the group of patients receiving prophylactic DexmedetomidineTimepoint: The heart rate & mean arterial pressure (MAP) of the patient will be monitored during Dexmedetomidine infusion & post ECT every 5 minutes up to 50 minutes post ECT.
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