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A study to compare time taken by two different drugs,cisatracurium and rocuronium, to completely relax the muscles of children during surgery under general anaesthesia.

Cis-atracurium versus Rocuronium: A prospective, randomized study comparing onset time in children undergoing surgery under general anaesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/02/007872
Enrollment
60
Registered
2017-02-15
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- Children of either sex scheduled to undergo short surgical procedures of 45- 60 minutes duration.

Interventions

Intervention1: Cis-atracurium besylate: Group C will receive cis-atracurium besylate 0.15 mg/kg diluted to 5 ml with normal saline slowly over 5 seconds. Control Intervention1: Rocuronium: Group R wil

Sponsors

Department Of Anaesthesia and Intensive Care
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Scheduled for short duration (60 minutes or less) elective surgeries requiring GA with controlled ventilation. 2.ASA (American Society of Anesthesiologists) grade I and II.

Exclusion criteria

Exclusion criteria: 1.ASA Grade III or above 2.Active upper respiratory tract infection with acute symptoms (fever, moist cough). 3.Concomitant drug treatment 4.Diseases affecting neuromuscular transmission (myopathies) 5.Any known contraindication to cis-atracurium and rocuronium. 6.Anticipated difficult airway.

Design outcomes

Primary

MeasureTime frame
To compare onset time of neuromuscular blockade of cis-atracurium versus rocuronium in children undergoing general anaesthesia (GA).Timepoint: Onset time will be taken as time interval from the completion of the intravenous (IV) injection of the muscle relaxant to maximal depression of all four twitch bars monitored by neuromuscular monitoring i.e. when even twitch one (T1)equals zero on the neuromuscular monitor.

Secondary

MeasureTime frame
Any adverse events.Timepoint: During entire period of anaesthesia.;Haemodynamic changesTimepoint: Baseline,Before induction 1 min. after induction,Before intubation,1 min after intubation,5 min,10 min,15 min,20 min,25 min,30 min,35 min,40min,45 min,50 min,55 min,60 min,65 min,70 min. ;Intubating conditions.Timepoint: Intubation time will be taken after attainment of a zero Train of four (TOF) count from picking up of laryngoscope up to successful endotracheal intubation as evidenced by square wave capnography on the monitor.;Recovery IndexTimepoint: Time interval from the end of clinical duration to 75 percent recovery of T1 on neuromuscular monitor;Skin temperatureTimepoint: Every 5 minutes during anaesthesia.;State Entropy (SE) and Response Entropy (RE)Timepoint: Every 5 minutes during anaesthesia.;Total duration of action.Timepoint: Total duration of action will be taken as time interval from the completion of the IV injection of the relaxant to spontaneous recovery of T1 to 25 % of the control value which reflects complete recovery from the block on neuromuscular monitor.

Countries

India

Contacts

Public ContactAbhijeet Anand

Government Medical College and Hospital,Sector 32,Chandigarh

mach2ranu@gmail.com9608443833

Outcome results

None listed

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