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Observational study of action of drug Cisatracurium(causing temporary paralysis for operation) in children

PROSPECTIVE OBSERVATIONAL STUDY OF ONSET AND DURATION OF ACTION OF NEUROMUSCULAR BLOCKADE WITH CISATRACURIUM 0.15mg/kg IN PAEDIATRIC PATIENTS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/04/032554
Enrollment
80
Registered
2021-04-06
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: 4- Measurement and Monitoring

Interventions

None listed

Sponsors

Dr Sebin Jose
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged > 1 month to 2. Any elective surgeries requiring general anaesthesia with endotracheal intubation where cisatracurium 0.15mg/kg is used as muscle relaxant

Exclusion criteria

Exclusion criteria: 1.Patients with full stomach /high risk of aspiration 2.Patients having anticipated difficult intubation 3. Patients having history of neuromuscular diseases 4. Patients on drugs known to affect neuromuscular blocking agents (e.g: Antibiotics (aminoglycosides, tetracyclines), antiarrhythmics(Calcium channel blockers, quinidine), Magnesium sulphate 5. Patient on anticonvulsants 6. Patients having history of allergy or asthma 7. Patients undergoing emergency laparotomies

Design outcomes

Primary

MeasureTime frame
1.To study the onset of action ( time from the injection of neuromuscular blocker to maximal suppression of T1 with cisatracurium 0.15mg/kg) 2. To study the intubating conditions at maximal suppression of twitch with cisatracurium 0.15mg/kg 3. To study the clinically effective duration of action, i.e. the time from neuromuscular blocker injection to 25% recovery of twitch height T1 4. To study the recovery index, i.e., the time from T1 recovery to 25% to 75% after last dose of cisatracurium Timepoint: Time of onset - time between injection of cisatracurium 0.15mg/kg and maximum suppression of T1, i.e. T1- 0%, in Train of Four monitoring Clinically effective duration of action-Time from injection of cisatracurium to 25% recovery of T1, in Train of Four monitoring Intubating conditions-assessed during endotracheal intubation Recovery index- time from T1 recovery to 25% to 75% after last dose of cisatracurium—

Secondary

MeasureTime frame
1.To study the effects of cisatracurium 0.15mg/kg over haemodynamics 2.To study the side effects if anyTimepoint: During first 4 hours after cisatracurium 0.15mg/kg administration—

Countries

India

Contacts

Public ContactAnila D Malde

Lokmanya Tilak municipal medical college and General hospital, Mumbai

dradmalde@yahoo.com9821085730

Outcome results

None listed

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