Anesthesia; FunctionalNCT03270696
Simultaneous Injection of Propofol and Rocuronium in Inducing General Anesthesia
A study testing administration of propofol and rocuronium in people with Anesthesia; Functional, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is conducted to evaluate the efficacy of simultaneous injection of propofol and rocuronium in inducing general anesthesia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anesthesia; Functional
- What is being tested?
- administration of propofol and rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Aug 2017to 30 Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective surgery requiring endotracheal intubation
- ASA I, II, and III
- above 20 years
Who cannot join
- refuse to enroll
- patients with risk of aspirating gastric contents
- patients in whom NMBs are contraindicated
- patients with predictors of difficult mask ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Neuromuscular Blockade Before Facemask Ventilation in Inducing General Anesthesia
This study is conducted to evaluate the efficacy of simultaneous injection of propofol and rocuronium in inducing general anesthesia.
- Conditions
- Anesthesia; Functional
- Being tested
- administration of propofol and rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of propofol and rocuroniumDrug
compare the tidal volume applied from starting facemask ventilation under 15cmH2O of PCV for 1 minute according to administrating propofol and rocuronium simultaneously, or ordinally
| Study group | Role | What they receive |
|---|---|---|
| simultaneous administration of propofol and rocuronium | Experimental | In this group, the investigator will administrate propofol (2ml/kg) and rocuronium (0.6mg/kg) simultaneously, and start facemask ventilation after patient loss consciousness to induce general anesthesia.
The investigator will measure the mean tidal volume (TV) applied during facemask ventilation for 1 minute. Receives: Drug: administration of propofol and rocuronium |
| ordinal administration of propofol and rocuronium | Experimental | In this group, the investigator will administrate propofol (2ml/kg) first, and follow injection of rocuronium (0.6mg/kg) after patient loss consciousness and confirming facemask ventilation.
The investigator will measure the mean tidal volume (TV) applied during facemask ventilation for 1 minute. Receives: Drug: administration of propofol and rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean tidal volume
mean tidal volume of facemask ventilation in 1 minute
Measured: from starting facemask ventilation for 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start23 Aug 2017
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; FunctionalStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Hwa Seo, Seoul National University Hospital
- Investigators
- JH Seo, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270696
- Sponsor's protocol ID
- JHSeo_MV
- Status last verified
- Sep 2017
- First submitted
- 23 Aug 2017
- Last updated
- 12 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Min SH, Im H, Kim BR, Yoon S, Bahk JH, Seo JH. Randomized Trial Comparing Early and Late Administration of Rocuronium Before and After Checking Mask Ventilation in Patients With Normal Airways. Anesth Analg. 2019 Aug;129(2):380-386. doi: 10.1213/ANE.0000000000004060.
PubMed 30768462
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Neuromuscular Blockade Before Facemask Ventilation in Inducing General Anesthesia
- ClinicalTrials.gov ID
- NCT03270696
- Acronym / sponsor ID
- JHSeo_MV
- Conditions
- Anesthesia; Functional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 1 Sep 2017 (actual)
- 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.
This study is conducted to evaluate the efficacy of simultaneous injection of propofol and rocuronium in inducing general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simultaneous administration of propofol and rocuronium | Experimental | Drug: administration of propofol and rocuroniumIn this group, the investigator will administrate propofol (2ml/kg) and rocuronium (0.6mg/kg) simultaneously, and start facemask ventilation after patient loss consciousness to induce general anesthesia. The investigator will measure the mean tidal volume (TV) applied during facemask ventilation for 1 minute. |
| ordinal administration of propofol and rocuronium | Experimental | Drug: administration of propofol and rocuroniumIn this group, the investigator will administrate propofol (2ml/kg) first, and follow injection of rocuronium (0.6mg/kg) after patient loss consciousness and confirming facemask ventilation. The investigator will measure the mean tidal volume (TV) applied during facemask ventilation for 1 minute. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing elective surgery requiring endotracheal intubation
- ASA I, II, and III
- above 20 years
Key exclusion criteria (4 listed)
- refuse to enroll
- patients with risk of aspirating gastric contents
- patients in whom NMBs are contraindicated
- patients with predictors of difficult mask ventilation
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 |
|---|---|---|
| administration of propofol and rocuroniumcompare the tidal volume applied from starting facemask ventilation under 15cmH2O of PCV for 1 minute according to administrating propofol and rocuronium simultaneously, or ordinally | Drug | ordinal administration of propofol and rocuronium, simultaneous administration of propofol and rocuronium |
Primary outcome
mean tidal volume
Time frame: from starting facemask ventilation for 1 minute
mean tidal volume of facemask ventilation in 1 minute
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 12 Apr 2018.
- Derived from this study: PubMed 30768462Min SH, Im H, Kim BR, Yoon S, Bahk JH, Seo JH. Randomized Trial Comparing Early and Late Administration of Rocuronium Before and After Checking Mask Ventilation in Patients With Normal Airways. Anesth Analg. 2019 Aug;129(2):380-386. doi: 10.1213/ANE.0000000000004060.
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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.
JH Seo principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing administration of propofol and rocuronium in people with Anesthesia; Functional, run by Seoul National University 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 3 inclusion and 4 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 12 Apr 2018. 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?
mean tidal volume (time frame: from starting facemask ventilation for 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03270696, which also lists 1 linked publication.
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 12 Apr 2018.