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
  Purpose

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 Intervention Phase
Rapid Sequence Intubation
Drug: Rocuronium-Sugammadex
Drug: Succinylcholine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 61
Study Start Date: September 2009
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953550

Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Rigshospitalet, Denmark
TrygFonden, Denmark
Investigators
Principal Investigator: Martin K Sørensen, MD Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Lars Rasmussen, Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet
ClinicalTrials.gov Identifier: NCT00953550     History of Changes
Other Study ID Numbers: 1B-RSI-SU
Study First Received: August 5, 2009
Last Updated: March 1, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Succinylcholine
Rocuronium
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Nondepolarizing Agents

ClinicalTrials.gov processed this record on July 20, 2014