Study of Rocuronium Onset Time According to Remifentanil Infusion
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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 |
- 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.
- mean arterial pressure (MAP) [ Time Frame: 15 minutes [4 times; during the induction of general anesthesia as described below.] ] [ Designated as safety issue: No ]
- 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.
- heart rate (HR) [ Time Frame: 15 minutes [4 times; during the induction of general anesthesia as described below.] ] [ Designated as safety issue: No ]
- 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.
- cardiac output [ Time Frame: 15 minutes [4 times; during the induction of general anesthesia as described below.] ] [ Designated as safety issue: No ]
- 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.
- 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:
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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:
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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 |
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
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:
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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 May 23, 2013