Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine

NCT ID: NCT00953550

Last Updated: 2011-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-02-28

Brief 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.

Conditions

Rapid Sequence Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Rocuronium-Sugammadex

Group Type: EXPERIMENTAL

Rocuronium-Sugammadex

Intervention Type: DRUG

Rocuronium 1,0 mg/kg is administered iv initially. Upon intubation Sugammadex is administered 16 mg/kg iv.

Succinylcholine

Group Type: ACTIVE_COMPARATOR

Succinylcholine

Intervention Type: DRUG

1 mg/kg

Interventions

Rocuronium-Sugammadex

Rocuronium 1,0 mg/kg is administered iv initially. Upon intubation Sugammadex is administered 16 mg/kg iv.

Intervention Type: DRUG

Succinylcholine

1 mg/kg

Intervention Type: DRUG

Other Intervention Names

Esmeron; Bridion; Suxameton; Suxamethon

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TrygFonden, Denmark

INDUSTRY

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet

Principal Investigators

Martin K Sørensen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, , Denmark

Herlev Hospital

Herlev, , Denmark

Countries

Denmark

Other Identifiers

1B-RSI-SU

Identifier Type: -

Identifier Source: org_study_id