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A study to compare the effectiveness of KETOFOL AND KETOFOL-DEXMEDETOMIDINE drugs in patients undergoing modified electroconvulsive therapy.

A randomised clinical trial to compare the effectiveness of KETOFOL and KETOFOL-DEXMEDETOMIDINE groups in patients undergoing modified electroconvulsive therapy. - NIL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057361
Enrollment
60
Registered
2023-09-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: F40-F48- Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders Health Condition 2: F01-F99- Mental, Behavioral and Neurodevelopmental disorders Health Condition 3: F20-F29- Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders

Interventions

Intervention1: ketofol-dexmedetomidine: In KFD -group 0.5 µg/kg dexmedetomidine (diluted to 10 ml with 0.9% saline) was infused intravenously over a period of 10 minutes and 10 minutes prior to the pr

Sponsors

Shri B M Patil Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with ASA Grade I & II

Exclusion criteria

Exclusion criteria: Cardiovascular disease, Cerebrovascular disorder, Intracranial hypertension, Respiratory tract disease, Glaucoma, Presence of a pacemaker, History of seizures, ASA III –V physical status, History of allergy to the study drugs, Pregnancy

Design outcomes

Primary

MeasureTime frame
To assess seizure duration To evaluate an acceptable decrease in heart rate & blood pressure (systolic, diastolic) Timepoint: 5 & 10 & 30 minutes after the end of the seizure

Secondary

MeasureTime frame
To assess agitation Timepoint: 24 hours;To assess depression , mania, psychosisTimepoint: 24 hours;To assess early post-M.E.C.T. complications. Timepoint: 24 hours

Countries

India

Contacts

Public ContactCharishma Buddha

Shri B M Patil Medical College, Vijayapura

dtalikoti@yahoo.co.in9844260391

Outcome results

None listed

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