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to compare quality of awakening after anesthesia in patients who recieve normal routine dose versus additional anticonvulsant dose during supratentorial craniotomy.

Comparison of recovery profile in patients receiving regular dose versus additional anticonvulsant does during supratentorial craniotomy. - Nil

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054486
Enrollment
60
Registered
2023-06-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere

Interventions

Control Intervention1: injection Fosphenytoin 4-6 mg/kg intravenous: additional dose of injection Fosphenytoin 4-6 mg/kg intravenous intraoperatively alongwith regular dosed received pre-operatively a

Sponsors

Mahatma Gandhi medical college and hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I, II, III Aged 18-60 years scheduled for supratentorial craniotomy for tumor resection patients who were receiving single anticonvulsant medication for more than one-week duration

Exclusion criteria

Exclusion criteria: Patient refusal History of allergy to the study drug Impaired renal/hepatic function. Severe left ventricular dysfunction, Seizures within one week prior to surgery despite the use of antiepileptic drug, patients who were on two anticonvulsants, Patients with GCS 4 cm associated with midline shift of >5 mm, surgery lasting longer than 5 hours with >30% blood volume loss

Design outcomes

Primary

MeasureTime frame
To assess the effect of prophylactic additional anticonvulsants on time to recovery from anaesthesia.Timepoint: Time taken from stopping the Isoflurane to extubation, eye-opening, to obey command & to get oriented will be taken as extubation time, eye-opening time, time to obey the command, time to orientation

Secondary

MeasureTime frame
â?¢Hemodynamic changes â?¢Depth of Anaesthesia â?¢Incidence of post operative seizure in first 48hours â?¢Plasma anticonvulsant levels Timepoint: heart rate, mean arterial blood pressure at 5,10,20,30,60,90,120,150,180,210 minutes

Countries

India

Contacts

Public ContactDr Sunita Sharma

Mahatma Gandhi Medical college and hospital, Jaipur

drsunitakhs@yahoo.com7597053927

Outcome results

None listed

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