AnesthesiaNCT01030510
Study of Rocuronium Onset Time According to Remifentanil Infusion
A study testing the order of drug administration in people with Anesthesia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- the order of drug administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: The Effect of Remifentanil on the Onset Time of Rocuronium in Total Intravenous Anesthesia
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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- the order of drug administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the order of drug administrationDrug
Also called esmeron, ultiva, fresopol
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.
| Study group | Role | What they receive |
|---|---|---|
| group R | Active comparator | In group R, remifentanil was infused first before administrating propofol and rocuronium Receives: Drug: the order of drug administration |
| group P | Active comparator | in group P, remifentanil was administered last after the propofol and rocuronium injection Receives: Drug: the order of drug administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
the onset time of rocuronium
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.
Measured: 3 minutes [after injection of rocuronium when general anesthesia is induced.]
Secondary outcomes (5)
mean arterial pressure (MAP)
- 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.
Measured: 15 minutes [4 times; during the induction of general anesthesia as described below.]
heart rate (HR)
- 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.
Measured: 15 minutes [4 times; during the induction of general anesthesia as described below.]
cardiac output
- 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.
Measured: 15 minutes [4 times; during the induction of general anesthesia as described below.]
pain from the propofol infusion
When propofol is administered for the induction of anesthesia, we investigate the pain by propofol.
Measured: 1 minute [at the time when propofol is administered.]
cough or chest wall rigidity from the remifentanil infusion
when remifentanil is infused, the cough or chest wall rigidity is checked.
Measured: 1 minute [at the time when remifentanil is infused.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030510
- Sponsor's protocol ID
- TIVA_rocu
- Status last verified
- Dec 2011
- First submitted
- 10 Dec 2009
- Last updated
- 16 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remifentanil on the Onset Time of Rocuronium in Total Intravenous Anesthesia
- ClinicalTrials.gov ID
- NCT01030510
- Acronym / sponsor ID
- TIVA_rocu
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 11 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group R | Active comparator | Drug: the order of drug administrationIn group R, remifentanil was infused first before administrating propofol and rocuronium |
| group P | Active comparator | Drug: the order of drug administrationin group P, remifentanil was administered last after the propofol and rocuronium injection |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the order of drug administrationAlso: esmeron, ultiva, fresopolIn 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. | Drug | group P, group R |
Primary outcome
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.
5 secondary outcomes
mean arterial pressure (MAP)
Time frame: 15 minutes [4 times; during the induction of general anesthesia as described below.]
heart rate (HR)
Time frame: 15 minutes [4 times; during the induction of general anesthesia as described below.]
cardiac output
Time frame: 15 minutes [4 times; during the induction of general anesthesia as described below.]
pain from the propofol infusion
Time frame: 1 minute [at the time when propofol is administered.]
cough or chest wall rigidity from the remifentanil infusion
Time frame: 1 minute [at the time when remifentanil is infused.]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the order of drug administration in people with Anesthesia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the onset time of rocuronium (time frame: 3 minutes [after injection of rocuronium when general anesthesia is induced.]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2011.