Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine - Full Text View

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:

Drug Information available for: Succinylcholine chloride Rocuronium bromide Rocuronium

U.S. FDA Resources

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

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 May 16, 2013