ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Rocuronium Onset Time According to Remifentanil Infusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01030510
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : December 16, 2011
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Anesthesia Drug: the order of drug administration Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: The Effect of Remifentanil on the Onset Time of Rocuronium in Total Intravenous Anesthesia
Study Start Date : December 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  1. mean arterial pressure (MAP) [ Time Frame: 15 minutes [4 times; during the induction of general anesthesia as described below.] ]
    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.

  2. heart rate (HR) [ Time Frame: 15 minutes [4 times; during the induction of general anesthesia as described below.] ]
    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.

  3. cardiac output [ Time Frame: 15 minutes [4 times; during the induction of general anesthesia as described below.] ]
    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.

  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: December 16, 2011
Last Verified: December 2011

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