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To compare the efficacy of two antiepileptic drugs in treatment of uncontrolled seizure.

Comparison of Midazolam and Target control based propofol infusion in Refractory status epilepticus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/014094
Enrollment
40
Registered
2018-05-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Refractory status epilepticus (RSE) is defined as status epilepticus that fails to respond to first- and any two drugs in the second-line anticonvulsant therapy

Interventions

Intervention1: Propofol: Group 2 will receive Target controlled based propofol infusion Intervention2: Control of seizure: Successful therapy: The status epilepticus is completely controlled by the t

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Adults patients with status epilepticus of any etiology who have not responded to the first line drugs like lorazepam and any of the two second line drugs like phenytoin, valproate, levetiracetam will be included in the study.

Exclusion criteria

Exclusion criteria: 1. No consent from the patientâ??s care-giver 2. Known allergy to the study drug 3. Patients having history coronary artery disease, documented clinical or echocardiac evidence of left ventricular dysfunction 4. Patients in shock

Design outcomes

Primary

MeasureTime frame
1. Control of clinical seizuresTimepoint: Successful therapy: The status epilepticus is completely controlled by the therapy, without breakthrough or withdrawal seizures, or discontinuation due to side-effects, or death during the therapy.

Secondary

MeasureTime frame
1. Length of ICU stay 2. Length of hospital stay 3. Duration of mechanical ventilation 4. Extended Glasgow outcome scale (GOS) /modified Rankin scale at the time of discharge 5. Systemic side effects a. Respiratory infection according to CDC guide lines b. AKI according to AKI guide lines c. Ionotropic support and duration of ionotropes. Timepoint: Extended Glasgow outcome scale (GOS) /modified Rankin scale at the time of discharge

Countries

India

Contacts

Public ContactDr Gopalakrishna K N

National Institute of Mental Health and Neurosciences

gsuma123@yahoo.com9480829710

Outcome results

None listed

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