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NCT Number: NCT00953550

Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine

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.

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Key information

Conditions

Rapid Sequence Intubation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rigshospitalet, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rocuronium-Sugammadex

Drug

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

Other names: Esmeron, Bridion

Succinylcholine

Drug

1 mg/kg

Other names: Suxameton, Suxamethon

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Intubation Difficulty Scale (IDS)

    Time frame: 20 minutes

  3. Intubation conditions

    Time frame: 20 minutes

  4. Side effect - Muscle ache.

    Time frame: Postoperative (within 24 hours)

  5. Side effect - Tachycardia (>100 beats per minute).

    Time frame: 20 minutes

  6. Side effect - Bradycardia (<50 beats per minute).

    Time frame: 20 minutes

  7. Side effect - Awareness/recall. Evaluated by modified Brice Questionaire.

    Time frame: Postoperative (within 24 hours)

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • TrygFonden, Denmark

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 6, 2009
Registry last updated
Mar 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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