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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 17 October 2016
Main ID:  ISRCTN11777647
Date of registration: 04/12/2015
Prospective Registration: No
Primary sponsor: University Medical Centre Maribor
Public title: Muscle relaxants for rapid sequence intubation
Scientific title: Rocuronium versus succinylcholine for rapid sequence intubation in patients with bowel obstruction
Date of first enrolment: 01/12/2013
Target sample size: 60
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN11777647
Study type:  Interventional
Study design:  Single-centre randomised parallel trial interventional study (Not Specified)  
Phase: 
Countries of recruitment
Slovenia
Contacts
Name: Lidija    PerÅ¡a
Address:  Ljubljanska ulica 5 2000 Maribor Slovenia
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
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Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Patient with bowel obstruction
2. Aged 18 years or over
3. Graded 2 and 3 on ASA Physical Status Classification System

Exclusion criteria: 1. Patients with known allergy for rocuronium or succinylcholine
2. Patients with increased potassium level
3. Patients with cronic or acute renal failure
4. Patients with whom difficulties with vocal cords visualisation and tracheal intubation are expected


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Bowel obstruction
Digestive System
Bowel obstruction
Intervention(s)
We are going to include patients with bowel obstruction who need an urgent operation. They are going to be divided in two groups using a random number generator. The patients are going to be prepared and intubated using rapid sequence intubation protocol. The first group is going to receive succinylcholine (1,5 mg/kg) and the second rocuronium (1,2 mg/kg). All drugs are going to be applied by the peripheral vein. The intubation is going to be performed 60 seconds after the application of muscular relaxant; muscular relaxation is going to be measured at the same time. We are going to evaluate the intubation conditions using grading system (the position and movement of the vocal cords, jaw relaxation and laryngoscopy resistance, coughing and movement).
Primary Outcome(s)
Quality of vocal cords visualisation is determined during the laryngoscopy 60 seconds after the muscular relaxant application using the visual scale (evaluating the position of vocal cords - whether are they adduced, in the midlle position or abduced at the time of laryngoscopy).
Secondary Outcome(s)
1. Potassium and mioglobin serum level measured five minutes before and after the RSI
2. Heart rate measured one minute before and after the RSI
3. Blood pressure measured one minute before and after the RSI
Secondary ID(s)
104/10/13
Source(s) of Monetary Support
University Medical Centre Maribor
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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