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EVALUATION OF EFFECT OF KETOFOL AND KETODEX IN ELECTROCONVULSIVE THERAPY

EVALUATION OF EFFECT OF KETOFOL AND KETODEX ON DURATION OF SEIZURE ACTIVITY,HEMODYNAMIC PROFILE,RECOVERY TIMES AND CORTICAL ACTIVITY(USING fNIRS) IN PATIENTS UNDERGOING ELECTROCONVULSIVE THERAPY FOR DEPRESSION

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034235
Enrollment
24
Registered
2021-06-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: F32- Major depressive disorder, singleepisode Health Condition 2: F32- Major depressive disorder, singleepisode Health Condition 3: F30-F39- Mood [affective] disorders

Interventions

Intervention1: Ketodex drug: ketodex (1-2 mg/kg ketamine and 1µg/kg dexmedetomidine) given as bolus over 5-10 min. This can then be followed by supplemental bolus doses of ketamine (0.5–1 mg/kg) as ne

Sponsors

All India Institute of Medical Sciences New Delhi India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All ASA 1-3 Patients who are scheduled for ECT treatment for depression

Exclusion criteria

Exclusion criteria: 1. Patients with any serious co-morbidities like cardiovascular disease cerebrovascular disease, intracranial hypertension and Respiratory tract infection. 2. Presence of foreign body like pacemaker clips and intracranial electrode. 3. History of substance abuse or dependence like alcohol 4. ASA 4-5 status 5. History of serious adverse effects related to anaesthesia drugs like allergy. 6. Co-existence of a psychiatric disorder along with major depression. 7. Pregnancy. 8. History of seizures.

Design outcomes

Primary

MeasureTime frame
To evaluate the effects of Ketofol and Ketodex on Duration of seizure activity (motor and EEG)Timepoint: within 15 min

Secondary

MeasureTime frame
Cortical activity(using fNIRS)Timepoint: within 20 min;Hemodynamic profile( HR ,SBP , DBP ,MAP)Timepoint: within 30 min;Recovery times(Spontaneous breathing, opens eye, obeys command)Timepoint: within 20 min

Countries

India

Contacts

Public ContactDR KAVINKUMAR K R

DEPARTMENT OF ANAESTHESIOLOGY , PAIN MEDICINE AND CRITICAL CARE , AIIMS , NEW DELHI

drshail.kumar@gmail.com8745027472

Outcome results

None listed

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