Study of Rocuronium Onset Time According to Remifentanil Infusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01030510
First received: December 10, 2009
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Anesthesia
Drug: the order of drug administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: The Effect of Remifentanil on the Onset Time of Rocuronium in Total Intravenous Anesthesia

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • the onset time of rocuronium [ Time Frame: 3 minutes [after injection of rocuronium when general anesthesia is induced.] ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • mean arterial pressure (MAP) [ Time Frame: 15 minutes [4 times; during the induction of general anesthesia as described below.] ] [ Designated as safety issue: No ]
    1. before induction (baseline): When a patient enter the operating room,
    2. at rocuronium administration: immediately before injecting rocuronium,
    3. before tracheal intubation: immediately before intubation,
    4. after tracheal intubation: immediately after intubation.

  • heart rate (HR) [ Time Frame: 15 minutes [4 times; during the induction of general anesthesia as described below.] ] [ Designated as safety issue: No ]
    1. before induction (baseline): When a patient enter the operating room,
    2. at rocuronium administration: immediately before injecting rocuronium,
    3. before tracheal intubation: immediately before intubation,
    4. after tracheal intubation: immediately after intubation.

  • cardiac output [ Time Frame: 15 minutes [4 times; during the induction of general anesthesia as described below.] ] [ Designated as safety issue: No ]
    1. before induction (baseline): When a patient enter the operating room,
    2. at rocuronium administration: immediately before injecting rocuronium,
    3. before tracheal intubation: immediately before intubation,
    4. after tracheal intubation: immediately after intubation.

  • pain from the propofol infusion [ Time Frame: 1 minute [at the time when propofol is administered.] ] [ Designated as safety issue: No ]
    When propofol is administered for the induction of anesthesia, we investigate the pain by propofol.

  • cough or chest wall rigidity from the remifentanil infusion [ Time Frame: 1 minute [at the time when remifentanil is infused.] ] [ Designated as safety issue: Yes ]
    when remifentanil is infused, the cough or chest wall rigidity is checked.


Enrollment: 126
Study Start Date: December 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: group R
In group R, remifentanil was infused first before administrating propofol and rocuronium
Drug: the order of drug administration
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
Active Comparator: group P
in group P, remifentanil was administered last after the propofol and rocuronium injection
Drug: the order of drug administration
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01030510

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Hyo-Seok Na, assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01030510     History of Changes
Other Study ID Numbers: TIVA_rocu
Study First Received: December 10, 2009
Last Updated: December 14, 2011
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Rocuronium
Remifentanil
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Opioid
Analgesics
Sensory System Agents
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on July 24, 2014