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NCT Number: NCT01030510

Study of Rocuronium Onset Time According to Remifentanil Infusion

The investigators therefore hypothesized that remifentanil could prolong the onset time of rocuronium, and evaluated the effect of remifentanil on the hemodynamic profiles (arterial pressure and heart rate) during the anesthetic induction sequence.

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Key information

Conditions

Anesthesia

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

It has been reported that co-administration of ephedrine reduced the onset time of neuromuscular block of rocuronium (1-3). It also provided an improved condition for the rapid tracheal intubation (2,4). This beneficial effect was attributed to the increased cardiac output and tissue perfusion to muscle, and therefore, a more rapid delivery of rocuronium to the neuromuscular junction was achieved (4-5). If so, any drugs which decrease cardiac output consequently can prolong the onset time of rocuronium.

Remifentanil is the first ultra-short acting opioid with a rapid onset. During the total intravenous anesthesia (TIVA) with propofol and remifentanil, prior administration of remifentanil could reduce the propofol infusion pain without other significant complications (6). However, remifentanil can decrease the arterial pressure and heart rate (7-8), so that it is likely to decrease the onset time of rocuronium for the opposite principle that ephedrine increases it.

The investigators therefore hypothesized that remifentanil could prolong the onset time of rocuronium, and evaluated the effect of remifentanil on the hemodynamic profiles (arterial pressure and heart rate) during the anesthetic induction sequence.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologist physical status I or II
  • Aged 20-65 yr
  • Elective surgery under general anesthesia with total intravenous anesthesia
  • 8.5 kg/m2 < body mass index (BMI) < 25 kg/m2

Exclusion criteria

  • BMI > 25 kg/m2 or < 18.5 kg/m2
  • Any cardiovascular or neuromuscular disease
  • Intake of drugs known to interact with the neuromuscular junction
  • Patients wit risk of pulmonary aspiration
  • Anticipated difficult airway
  • history of known allergy to rocuronium

Treatment and study plan

the order of drug administration

Drug

In group R, remifentanil was infused first before administrating propofol and rocuronium and in group P, it was administered last after the rocuronium injection. In other words, the order of drug infusion in each group is remifentanil-propofol-rocuronium in group R and propofol-rocuronium-remifentanil in group P, respectively.

Other names: esmeron, ultiva, fresopol

Primary outcomes

  1. the onset time of rocuronium

    Time frame: 3 minutes [after injection of rocuronium when general anesthesia is induced.]

    Onset time of rocuronium was defined as the time from the end of its injection to the 95% depression of single twitch response, and it was measured by an anaesthesiologist, unaware of the group allocation.

Secondary outcomes

  1. mean arterial pressure (MAP)

    Time frame: 15 minutes [4 times; during the induction of general anesthesia as described below.]

    • before induction (baseline): When a patient enter the operating room,
    • at rocuronium administration: immediately before injecting rocuronium,
    • before tracheal intubation: immediately before intubation,
    • after tracheal intubation: immediately after intubation.

  2. heart rate (HR)

    Time frame: 15 minutes [4 times; during the induction of general anesthesia as described below.]

    • before induction (baseline): When a patient enter the operating room,
    • at rocuronium administration: immediately before injecting rocuronium,
    • before tracheal intubation: immediately before intubation,
    • after tracheal intubation: immediately after intubation.

  3. cardiac output

    Time frame: 15 minutes [4 times; during the induction of general anesthesia as described below.]

    • before induction (baseline): When a patient enter the operating room,
    • at rocuronium administration: immediately before injecting rocuronium,
    • before tracheal intubation: immediately before intubation,
    • after tracheal intubation: immediately after intubation.

  4. pain from the propofol infusion

    Time frame: 1 minute [at the time when propofol is administered.]

    When propofol is administered for the induction of anesthesia, we investigate the pain by propofol.

  5. cough or chest wall rigidity from the remifentanil infusion

    Time frame: 1 minute [at the time when remifentanil is infused.]

    when remifentanil is infused, the cough or chest wall rigidity is checked.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

The Effect of Remifentanil on the Onset Time of Rocuronium in Total Intravenous Anesthesia

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 11, 2009
Registry last updated
Dec 16, 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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