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Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine

NCT00953550 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2011-03-02

No results posted yet for this study

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

Interventions

DRUG

Rocuronium-Sugammadex

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

DRUG

Succinylcholine

1 mg/kg

Sponsors & Collaborators

  • TrygFonden, Denmark

    collaborator INDUSTRY

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Martin K Sørensen, MD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-01-31
Completion
2011-02-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00953550 on ClinicalTrials.gov