Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine
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|ClinicalTrials.gov Identifier: NCT00953550|
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : March 2, 2011
Rapid sequence intubation is used, when there is an elevated risk of aspiration to the lungs of stomach content. It is typically used in acute settings that require acute surgery or in prehospital settings, but also in specific risk patients requiring elective surgery. The reason for conducting rapid sequence intubation is to minimize the risk of pulmonary aspiration and at the same time achieve a fast induction of anaesthesia and intubation. Rapid sequence intubation is a procedure with a high risk of complications in itself. The time period from induction of anaesthesia to intubation is particularly risky, because the patient is apneic. This study addresses this problem by investigating, how quickly spontaneous respiration can be reestablished after a rapid sequence intubation when using Rocuronium-Sugammadex compared to Succinylcholine. This is a pilot protocol that is intended to establish a sample size for the full protocol.
Study hypothesis: The time from correct tube placement to spontaneous respiration is shorter when using Rocuronium/Sugammadex compared to Succinylcholine.
|Condition or disease||Intervention/treatment||Phase|
|Rapid Sequence Intubation||Drug: Rocuronium-Sugammadex Drug: Succinylcholine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||February 2011|
Rocuronium 1,0 mg/kg is administered iv initially. Upon intubation Sugammadex is administered 16 mg/kg iv.
|Active Comparator: Succinylcholine||
- Time from verified correct tube placement after intubation to spontaneous respiration, defined as respiration frequency of >8/minute, tidal volume >3ml/kg and a saturation of >90% for 30 seconds. [ Time Frame: 20 minutes ]
- Duration of action. Measured as the time from administration of the neuromuscular blocking agent to the T1-value in Train-of-Four (TOF) returns to >90% of T1-max. [ Time Frame: 20 minutes ]
- Intubation Difficulty Scale (IDS) [ Time Frame: 20 minutes ]
- Intubation conditions [ Time Frame: 20 minutes ]
- Side effect - Muscle ache. [ Time Frame: Postoperative (within 24 hours) ]
- Side effect - Tachycardia (>100 beats per minute). [ Time Frame: 20 minutes ]
- Side effect - Bradycardia (<50 beats per minute). [ Time Frame: 20 minutes ]
- Side effect - Awareness/recall. Evaluated by modified Brice Questionaire. [ Time Frame: Postoperative (within 24 hours) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953550
|Copenhagen, Denmark, 2100|
|Herlev, Denmark, 2730|
|Principal Investigator:||Martin K Sørensen, MD||Rigshospitalet, Denmark|