Comparing two muscle relaxants, Cis-atracurium and Atracurium, to check which provides better conditions for inserting a breathing tube and keeps childrens vital signs more stable during surgery

A comparative study between Cis-atracurium and Atracurium for assessment of intubating conditions and hemodynamic stability in pediatric patients undergoing surgery: A randomised double blind study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091952

Enrollment

Registered

2025-07-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Endotracheal intubation using Cis-atracurium: Patient of age 3 to 12 years posted for surgery requiring general anesthesia will be given premedication intravenous with inj. midazolam 0.

Eligibility

Inclusion criteria

Inclusion criteria: a Patient s guardian consent b Age group 3 to 12 years c ASA grade 1 and 2 d Patient posted for surgery requiring general anaesthesia and endotracheal intubation e Expected duration of surgery should be less than 90 minutes

Exclusion criteria

Exclusion criteria: a ASA grade 3 and 4 b Anticipated difficult airway c Comorbid conditions d Upper and lower respiratory tract infection e Known history of allergy to any of the study drug

Design outcomes

Primary

Measure	Time frame
To compare effectiveness of Cis-atracurium and Atracurium at dose of 0.2mg/kg and 0.5mg/kg respectively with regards to intubating conditions. Intubating conditions will be assessed using Cooper et al scoring system.Timepoint: 3minutes after injection of muscle relaxant, laryngoscopy will be performed. At the time of laryngoscopy, and just after intubation, intubating conditions will be assessed using Cooper et al scoring system.	—

Measure

Time frame

To compare effectiveness of Cis-atracurium and Atracurium at dose of 0.2mg/kg and 0.5mg/kg respectively with regards to intubating conditions. Intubating conditions will be assessed using Cooper et al scoring system.Timepoint: 3minutes after injection of muscle relaxant, laryngoscopy will be performed. At the time of laryngoscopy, and just after intubation, intubating conditions will be assessed using Cooper et al scoring system.

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Secondary

Measure	Time frame
To assess hemodynamic stability. Systolic Blood pressure, Diastolic blood pressure, Mean Arterial Pressure, Heart rate will be monitored at given time points.Timepoint: 1. baseline parameters before induction 2. 3minutes after preoxygenation with 100 percent oxygen & Intravenous injection of Inj.Propofol. 3. 3minutes after injection of muscle relaxant but before intubation. 4. Immediately after intubation 5. After endotracheal intubation hemodynamic parameters will be assessed at 5minutes, 10minutes, 15minutes, 20minutes, 25minutes, 30minutes 45minutes, 60minutes, 75minutes, 90minutes intraoperatively	—

Measure

Time frame

To assess hemodynamic stability. Systolic Blood pressure, Diastolic blood pressure, Mean Arterial Pressure, Heart rate will be monitored at given time points.Timepoint: 1. baseline parameters before induction 2. 3minutes after preoxygenation with 100 percent oxygen & Intravenous injection of Inj.Propofol. 3. 3minutes after injection of muscle relaxant but before intubation. 4. Immediately after intubation 5. After endotracheal intubation hemodynamic parameters will be assessed at 5minutes, 10minutes, 15minutes, 20minutes, 25minutes, 30minutes 45minutes, 60minutes, 75minutes, 90minutes intraoperatively

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Countries

India

Contacts

Public ContactDr Mukesh Kumar

Rajendra Institute of Medical Sciences

drpkt80@gmail.com9661883797

Outcome results

None listed

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