Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine

Rapid Sequence Intubation Clinical Trial

Official title:

Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00953550
• Other study ID #: 1B-RSI-SU
• Status: Completed
• Phase: Phase 4
• First received: August 5, 2009
• Last updated: March 1, 2011
• Start date: September 2009
• Est. completion date: February 2011

Study information

• Verified date: December 2010
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rapid Sequence Intubation

Intervention

Drug:
• Rocuronium-Sugammadex
Rocuronium 1,0 mg/kg is administered iv initially. Upon intubation Sugammadex is administered 16 mg/kg iv.
• Succinylcholine
1 mg/kg

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev Hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		20 minutes	Yes
Secondary	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.		20 minutes	No
Secondary	Intubation Difficulty Scale (IDS)		20 minutes	Yes
Secondary	Intubation conditions		20 minutes	Yes
Secondary	Side effect - Muscle ache.		Postoperative (within 24 hours)	Yes
Secondary	Side effect - Tachycardia (>100 beats per minute).		20 minutes	Yes
Secondary	Side effect - Bradycardia (<50 beats per minute).		20 minutes	Yes
Secondary	Side effect - Awareness/recall. Evaluated by modified Brice Questionaire.		Postoperative (within 24 hours)	Yes