Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine

This study has been completed.
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00953550
First received: August 5, 2009
Last updated: March 1, 2011
Last verified: December 2010

August 5, 2009
March 1, 2011
September 2009
January 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Time from verified correct tube placement after intubation to spontaneous respiration, defined as respiration frequency of >8/minute, tidalvolume >3ml/kg and a saturation of >90% for 30 seconds. [ Time Frame: During induction of anaesthesia ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00953550 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Intubation Difficulty Scale (IDS) [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]
  • Intubation conditions [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]
  • Side effect - Muscle ache. [ Time Frame: Postoperative (within 24 hours) ] [ Designated as safety issue: Yes ]
  • Side effect - Tachycardia (>100 beats per minute). [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]
  • Side effect - Bradycardia (<50 beats per minute). [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]
  • Side effect - Awareness/recall. Evaluated by modified Brice Questionaire. [ Time Frame: Postoperative (within 24 hours) ] [ Designated as safety issue: Yes ]
  • Duration of action. Measured as the time from administration of the neuromuscular blocking agent to a Train of Four value (TOF) returns to >90%. [ Time Frame: During induction of anaesthesia ] [ Designated as safety issue: No ]
  • Intubation Difficulty Scale (IDS) [ Time Frame: During induction of anaesthesia ] [ Designated as safety issue: Yes ]
  • Intubation conditions [ Time Frame: During induction of anaesthesia ] [ Designated as safety issue: Yes ]
  • Side effect - Muscle ache. [ Time Frame: During induction of anaesthesia ] [ Designated as safety issue: Yes ]
  • Side effect - Tachycardia (>100 beats per minute). [ Time Frame: During induction of anaesthesia ] [ Designated as safety issue: Yes ]
  • Side effect - Bradycardia (<50 beats per minute). [ Time Frame: During induction of anaesthesia ] [ Designated as safety issue: Yes ]
  • Side effect - Awareness/recall. Evaluated by modified Brice Questionaire. [ Time Frame: Postoperative ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine
Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rapid Sequence Intubation
  • 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
  • Drug: Succinylcholine
    1 mg/kg
    Other Names:
    • Suxameton
    • Suxamethon
  • Experimental: Rocuronium-Sugammadex
    Intervention: Drug: Rocuronium-Sugammadex
  • Active Comparator: Succinylcholine
    Intervention: Drug: Succinylcholine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
February 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00953550
1B-RSI-SU
Yes
Lars Rasmussen, Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet
Rigshospitalet, Denmark
TrygFonden, Denmark
Principal Investigator: Martin K Sørensen, MD Rigshospitalet, Denmark
Rigshospitalet, Denmark
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP