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Completed

NCT Number: NCT05725031

Intubation Conditions After RSI Using Rocuronium with Ephedrine Pretreatment

This trial will study if ephedrine pretreatment before low doses of rocuronium (0.6 or 0.8 mg/kg) would provide similar intubating conditions as with the high dose of 1.2 mg/kg in patients undergoing RSII.

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Key information

Conditions

Rapid Sequence Induction and Intubation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ain Shams University Hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA physical status I or II

Exclusion criteria

  • Neuromuscular disease: myopathies
  • On drugs that interact with the neuromuscular junction or ephedrine
  • Cardiovascular disease: hypertension or ischemic heart disease
  • Increased risk of pulmonary aspiration:
  • GERD
  • Pregnancy
  • Anticipated airway difficulties:
  • Mallampati grade III or IV
  • Obesity (BMI ≥30 kg/m2),
  • Hypersensitivity to any of the study drugs

Treatment and study plan

Ephedrine

Drug

70 μg/kg as pretreatment

Rocuronium 0.6

Drug

0.6 mg/kg

Rocuronium 0.8

Drug

0.8 mg/kg

Rocuronium 1.2

Drug

1.2 mg/kg

Primary outcomes

  1. Intubation conditions

    Time frame: after 60 seconds of rocuronium administration

    Evaluation of intubation conditions after rapid sequence induction using rocuronium 0.6 or 0.8 mg/kg with ephedrine pretreatment, compared with 1.2 mg/kg, according to the criteria of the Good Clinical Research Practice (GCRP) in pharmacodynamic studies of NMBAs (Fuchs-Buder et al., 2007), which assess each of the following variables for their qualities described as: (excellent, good, poor)

    • ease of laryngoscopy (easy, fair, difficult)
    • vocal cords position (abducted, intermediate, closed)
    • reaction to tracheal tube insertion and cuff inflation (coughing: none, slight, vigorous)

    The 3 variables will be combined to describe intubation conditions as:

    • Excellent: if all qualities are excellent
    • Good: if all qualities are either excellent or good
    • Poor: if there is a single poor quality

Secondary outcomes

  1. Heart rate

    Time frame: every minute of the first 5 minutes of intubation

    Following up the heart rate on the monitor

  2. Mean arterial pressure

    Time frame: every minute of the first 5 minutes of intubation

    Following up the mean arterial pressure by noninvasive blood pressure monitoring

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Intubation Conditions After Rapid Sequence Induction Using Different Doses of Rocuronium with Ephedrine Pretreatment: a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2023
Registry last updated
Oct 15, 2024

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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