Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine
Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rapid Sequence Intubation
Intervention: Rocuronium-Sugammadex (Drug); Succinylcholine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Rigshospitalet, Denmark Official(s) and/or principal investigator(s):
Martin K Sørensen, MD, Principal Investigator, Affiliation: Rigshospitalet, Denmark
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.
Clinical Details
Official title: Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: 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.Intubation Difficulty Scale (IDS) Intubation conditions Side effect - Muscle ache. Side effect - Tachycardia (>100 beats per minute). Side effect - Bradycardia (<50 beats per minute). Side effect - Awareness/recall. Evaluated by modified Brice Questionaire.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Rigshospitalet, Copenhagen 2100, Denmark
Herlev Hospital, Herlev 2730, Denmark
Additional Information
Starting date: September 2009
Last updated: March 1, 2011
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