Muscle RelaxantPhase 1NCT02575716
Comparison of Intubating Condition of the Mcgrath Videolaryngoscope With and Without Muscle Relaxant
A Phase 1 study testing Videolaryngoscope in people with Muscle Relaxant, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
The objective of this study was to evaluate intubating condition using the McGrath® VL Series 5, with and without muscle relaxant Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Relaxant
- What is being tested?
- Videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2013to Mar 2014
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years old.
- ASA class I-II.
- Elective surgery required general anesthesia with oroendotracheal intubation
Who cannot join
- Suspected or known difficult airway.
- Patient with risk of aspiration with required of rapid sequence induction .
- Plan remained intubation.
- Allergic to drugs used in the study.
- Renal or hepatic disease.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of anesthesiology
Hat Yai, Changwat Songkhla, 90110
About this study
The objective of this study was to evaluate intubating condition using the McGrath® VL Series 5, with and without muscle relaxant
Read the detailed description
Thirty-four patients with ASA classification I-II, who required oroendotracheal tube intubation, were studied in this prospective, double-blinded, randomized, clinical trial. Anesthesia was induced using fentanyl 1.5 mcg/kg, xylocaine 1.5 mg/kg and propofol 3 mg/kg. Patients were randomly assigned to one of the two groups to receive either rocuronium 0.6 mg/kg or saline intravenously. The Mcgrath® VL intubation was initiated after 90s, when the patients were fully relaxed. The primary outcome was to compare tracheal intubating conditions between two groups. The secondary outcomes were the success rate in the first attempt intubation, time to intubation, the required propofol dose for intubation and anesthetic complications. Statistical analyses were performed using the R program version 2.14.2. The level of statistical significance was set at p < 0.05.
- Conditions
- Muscle Relaxant
- Being tested
- Videolaryngoscope
- Keywords
- McGrath®, Videolaryngoscope, intubating condition, muscle relaxant, intubation
- Medical subject headings
- Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideolaryngoscopeDevice
Intubation with McGrath video laryngoscope after muscle relaxant
| Study group | Role | What they receive |
|---|---|---|
| Muscle relaxant | Experimental | Intubation with McGrath video laryngoscope after fentanyl 1.5 mcg/kg, xylocaine 1.5 mg/kg and propofol 3 mg/kg muscle relaxant use rocuronium 0.6 mg/kg Receives: Device: Videolaryngoscope |
| Placebo | Placebo comparator | Intubation with McGrath video laryngoscope after fentanyl 1.5 mcg/kg, xylocaine 1.5 mg/kg and propofol 3 mg/kg placebo use NSS 0.6 mg/kg Receives: Device: Videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubating condition.
number of participants with 34 people
Measured: one year
Secondary outcomes (4)
Success rate in the first attempt intubation.
Measured: one year
Time to intubation
Measured: One year
The required propofol dose for intubation without muscle relaxant.
Measured: one year
Events during the intubation attempts occurred.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle RelaxantStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piyaporn Vasinanukorn, Prince of Songkla University
- Investigators
- Piyaporn Vasinanukorn, MD., Study chair, Prince of Songklanagarind University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575716
- Sponsor's protocol ID
- PSU-561330812
- Status last verified
- Oct 2015
- First submitted
- 7 Oct 2015
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intubating Condition of the Mcgrath Videolaryngoscope With and Without Muscle Relaxant
- ClinicalTrials.gov ID
- NCT02575716
- Acronym / sponsor ID
- PSU-561330812
- Conditions
- Muscle Relaxant
- Keywords
- McGrath®, Videolaryngoscope, intubating condition, muscle relaxant, intubation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 15 Oct 2015 (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 objective of this study was to evaluate intubating condition using the McGrath® VL Series 5, with and without muscle relaxant
Detailed description
Thirty-four patients with ASA classification I-II, who required oroendotracheal tube intubation, were studied in this prospective, double-blinded, randomized, clinical trial. Anesthesia was induced using fentanyl 1.5 mcg/kg, xylocaine 1.5 mg/kg and propofol 3 mg/kg. Patients were randomly assigned to one of the two groups to receive either rocuronium 0.6 mg/kg or saline intravenously. The Mcgrath® VL intubation was initiated after 90s, when the patients were fully relaxed. The primary outcome was to compare tracheal intubating conditions between two groups. The secondary outcomes were the success rate in the first attempt intubation, time to intubation, the required propofol dose for intubation and anesthetic complications. Statistical analyses were performed using the R program version 2.14.2. The level of statistical significance was set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle relaxant | Experimental | Device: VideolaryngoscopeIntubation with McGrath video laryngoscope after fentanyl 1.5 mcg/kg, xylocaine 1.5 mg/kg and propofol 3 mg/kg muscle relaxant use rocuronium 0.6 mg/kg |
| Placebo | Placebo comparator | Device: VideolaryngoscopeIntubation with McGrath video laryngoscope after fentanyl 1.5 mcg/kg, xylocaine 1.5 mg/kg and propofol 3 mg/kg placebo use NSS 0.6 mg/kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years old.
- ASA class I-II.
- Elective surgery required general anesthesia with oroendotracheal intubation
Key exclusion criteria (5 listed)
- Suspected or known difficult airway.
- Patient with risk of aspiration with required of rapid sequence induction .
- Plan remained intubation.
- Allergic to drugs used in the study.
- Renal or hepatic disease.
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 |
|---|---|---|
| VideolaryngoscopeIntubation with McGrath video laryngoscope after muscle relaxant | Device | Muscle relaxant, Placebo |
Primary outcome
Intubating condition.
Time frame: one year
number of participants with 34 people
4 secondary outcomes
Success rate in the first attempt intubation.
Time frame: one year
Time to intubation
Time frame: One year
The required propofol dose for intubation without muscle relaxant.
Time frame: one year
Events during the intubation attempts occurred.
Time frame: one year
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 15 Oct 2015.
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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.
Piyaporn Vasinanukorn, MD. study chair
Prince of Songklanagarind University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Videolaryngoscope in people with Muscle Relaxant, run by Prince of Songkla University at 1 site in Thailand.
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 5 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 15 Oct 2015. 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 Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intubating condition. (time frame: one year). 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 15 Oct 2015.