Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine
1 other identifier
interventional
61
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedMarch 2, 2011
December 1, 2010
1.3 years
August 5, 2009
March 1, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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.
20 minutes
Secondary Outcomes (7)
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.
20 minutes
Intubation Difficulty Scale (IDS)
20 minutes
Intubation conditions
20 minutes
Side effect - Muscle ache.
Postoperative (within 24 hours)
Side effect - Tachycardia (>100 beats per minute).
20 minutes
- +2 more secondary outcomes
Study Arms (2)
Rocuronium-Sugammadex
EXPERIMENTALSuccinylcholine
ACTIVE COMPARATORInterventions
Rocuronium 1,0 mg/kg is administered iv initially. Upon intubation Sugammadex is administered 16 mg/kg iv.
Eligibility Criteria
You may qualify if:
- Elective surgical patients with a planned rapid sequence induction of anaesthesia.
- Informed consent.
- Legally competent.
- Be able to understand Danish and be able to read the given information in Danish.
- Females can only participate if they have reached menopause, have had hysterectomy performed, use a coil as birthcontrol, or if they are sterilized.
You may not qualify if:
- Presence of kidney disease, defined as S-creatinine \>0,200 mmol/L.
- Known lung or heart disease, defined as NYHA-class \>2 or CCS-class \>2.
- Known allergic reactions to Rocuronium, Suxamethon, Propofol or Sugammadex.
- Contraindications to Suxamethon. Including raised P-potassium (\>5,0 mmol/L), untreated glaucoma, neuromuscular disorders or disposition to malignant hyperthermia.
- Body mass index of \>35 kg/m2.
- Pregnant.
- Breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- TrygFonden, Denmarkcollaborator
Study Sites (2)
Rigshospitalet
Copenhagen, 2100, Denmark
Herlev Hospital
Herlev, 2730, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin K Sørensen, MD
Rigshospitalet, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 5, 2009
First Posted
August 6, 2009
Study Start
September 1, 2009
Primary Completion
January 1, 2011
Study Completion
February 1, 2011
Last Updated
March 2, 2011
Record last verified: 2010-12