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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:
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ISRCTN |
Last refreshed on:
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17 October 2016 |
Main ID: |
ISRCTN11777647 |
Date of registration:
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04/12/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Muscle relaxants for rapid sequence intubation
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Scientific title:
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Rocuronium versus succinylcholine for rapid sequence intubation in patients with bowel obstruction |
Date of first enrolment:
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01/12/2013 |
Target sample size:
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60 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN11777647 |
Study type:
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Interventional |
Study design:
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Single-centre randomised parallel trial interventional study (Not Specified)
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Phase:
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Lidija
Perša |
Address:
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Ljubljanska ulica 5
2000
Maribor
Slovenia |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Bowel obstruction Digestive System Bowel obstruction
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Intervention(s)
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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).
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Primary Outcome(s)
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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).
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Secondary Outcome(s)
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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
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Secondary ID(s)
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104/10/13
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Source(s) of Monetary Support
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University Medical Centre Maribor
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Results
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Results available:
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Date Completed:
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