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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
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by:
Rigshospitalet, Denmark

Study Description
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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.


Condition or disease Intervention/treatment Phase
Rapid Sequence Intubation Drug: Rocuronium-Sugammadex Drug: Succinylcholine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Rocuronium-Sugammadex Drug: Rocuronium-Sugammadex
Rocuronium 1,0 mg/kg is administered iv initially. Upon intubation Sugammadex is administered 16 mg/kg iv.
Other Names:
  • Esmeron
  • Bridion
Active Comparator: Succinylcholine Drug: Succinylcholine
1 mg/kg
Other Names:
  • Suxameton
  • Suxamethon


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 20 minutes ]

Secondary Outcome Measures :
  1. 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 ]
  2. Intubation Difficulty Scale (IDS) [ Time Frame: 20 minutes ]
  3. Intubation conditions [ Time Frame: 20 minutes ]
  4. Side effect - Muscle ache. [ Time Frame: Postoperative (within 24 hours) ]
  5. Side effect - Tachycardia (>100 beats per minute). [ Time Frame: 20 minutes ]
  6. Side effect - Bradycardia (<50 beats per minute). [ Time Frame: 20 minutes ]
  7. Side effect - Awareness/recall. Evaluated by modified Brice Questionaire. [ Time Frame: Postoperative (within 24 hours) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Rigshospitalet, Denmark
TrygFonden, Denmark
Investigators
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Principal Investigator: Martin K Sørensen, MD Rigshospitalet, Denmark
More Information
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Responsible Party: Lars Rasmussen, Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet
ClinicalTrials.gov Identifier: NCT00953550    
Other Study ID Numbers: 1B-RSI-SU
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: March 2, 2011
Last Verified: December 2010
Additional relevant MeSH terms:
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Rocuronium
Succinylcholine
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neuromuscular Depolarizing Agents