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
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
Muscle relaxant is crucial component of general anesthesia which facilitates laryngoscopy and endotracheal intubation, prevents voluntary and reflex movements preventing vocal cord damage. Cis-atracurium and Atracurium are Non depolarising muscle relaxant. Cis-atracurium is 4 times more potent than Atracurium with their ED95 being 0.05mg/kg and 0.23mg/kg respectively. The study is to compare the effectiveness of Cis-atracurium and Atracurium at dose of 4ED95 and 2ED95 which is 0.2mg/kg and 0.5mg/kg respectively with regards to intubating conditions and hemodynamic stability.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 3.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
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
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: 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.
Secondary Outcomes
- To assess hemodynamic stability. Systolic Blood pressure, Diastolic blood pressure, Mean Arterial Pressure, Heart rate will be monitored at given time points.(1. baseline parameters before induction)
Investigators
Abhishek Hansdak
Rajendra Institute of Medical Sciences