Clinical trial NCT01030510: Study of Rocuronium Onset Time According to Remifentanil Infusion
Official title: The Effect of Remifentanil on the Onset Time of Rocuronium in Total Intravenous Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2009-12-11
Enrollment: 126
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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

Primary outcomes:
measure: the onset time of rocuronium
timeFrame: 3 minutes [after injection of rocuronium when general anesthesia is induced.]
Secondary outcomes:
measure: mean arterial pressure (MAP)
timeFrame: 15 minutes [4 times; during the induction of general anesthesia as described below.]
measure: heart rate (HR)
timeFrame: 15 minutes [4 times; during the induction of general anesthesia as described below.]
measure: cardiac output
timeFrame: 15 minutes [4 times; during the induction of general anesthesia as described below.]
measure: pain from the propofol infusion
timeFrame: 1 minute [at the time when propofol is administered.]
measure: cough or chest wall rigidity from the remifentanil infusion
timeFrame: 1 minute [at the time when remifentanil is infused.]
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References: