Skip to content

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

Effect of prophylactic dexmedetomidine on the incidence and duration of post electroconvulsive therapy delirium in psychiatry patients in a tertiary care hospital - a randomised, double-blinded, placebo controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053541
Enrollment
80
Registered
2023-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders

Interventions

Intervention1: Intravenous Dexmedtomidine: This study will be conducted as prospective, double blinded, placebo controlled randomised trial. The test group will receive Dexmedetomidine (0.5 mcg/kg) as

Sponsors

Kasturba Medical College Manipal
Lead Sponsor
Mathew Tom
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anaesthesiologists Physical Status Classification I and II patients 2. Age between 18-65 undergoing ECT

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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. The delirium will be measured from 10 minutes after the ECT upto 50 minutes after ECT at an interval of 10 minutes each.

Secondary

MeasureTime frame
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.

Countries

India

Contacts

Public ContactMathew Tom

Kasturba Medical College, Manipal

hm.krishna@manipal.edu984542862

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026