Randomised controlled trial to determine the effect of prophylactic dexmedetomidine on the incidence and duration of post electroconvulsive therapy delirium
- 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
1.American Society of Anaesthesiologists Physical Status Classification I and II patients
2.Age between 18-65 undergoing ECT
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
Name Time Method 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
Name Time Method 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.