LaryngismusNCT01456299
Laryngeal Mask Airway (LMA) Insertion With Sevoflurane and Remifentanil
A study testing Remifentanil 1 and Remifentanil 2 in people with Laryngismus, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study was to determine the most suitable effect-site concentration of remifentanil for the LMA insertion during inhaled induction with 8% sevoflurane in adults. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Laryngismus
- What is being tested?
- Remifentanil 1 and Remifentanil 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients, aged 18-60 with ASA physical status I or II, who were scheduled to minor elective surgery (< 1 h) were considered for the study
Who cannot join
- Exclusion criteria were allergies to the study drugs, a history of gastric reflux, a history of drug abuse, obesity (body mass index > 30 kg/m2) and suspected difficult airway
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Target-controlled Infusion of Remifentanil for Laryngeal Mask Airway Insertion During Sevoflurane Induction in Adults
The purpose of this study was to determine the most suitable effect-site concentration of remifentanil for the LMA insertion during inhaled induction with 8% sevoflurane in adults.
Read the detailed description
For practical purposes, opioids with the ability to suppress upper airway reflexes have been used to facilitate insertion of the LMA during anaesthesia induction. To date, however, there have been no published reports addressing the use of remifentanil to facilitate LMA insertion during sevoflurane inhalation induction in adults. Therefore, the purpose of this study was to determine the most suitable effect-site concentration of remifentanil target-controlled infusion (TCI) for the LMA insertion during inhaled induction with 8% sevoflurane in adults.
- Conditions
- Laryngismus
- Being tested
- Remifentanil 1, Control, Remifentanil 2
- Keywords
- laryngeal mask airway, insertion, sevoflurane, remifentanil
- Medical subject headings
- Laryngismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil 1Drug
Also called R1
"Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml.
ControlDrug
Also called Placebo
The control group, which received an infusion of normal saline
Remifentanil 2Drug
Also called R2
"Remifentanil 2": "The R2group, which received a target effect-site remifentanil concentration of 2 ng/ml.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | The control group, which received an infusion of normal saline. Receives: Drug: Control |
| Remifentanil 1 | Active comparator | "Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml. Receives: Drug: Remifentanil 1 |
| Remifentanil 2 | Active comparator | "Remifentanil 2": "The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml. Receives: Drug: Remifentanil 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
LMA Insertion Condition
The pre-determined effect-site concentration of remifentanil or normal saline was administered according to the patient's group.LMAs were size #3 for women and #4 for men.The conditions of the LMA insertion were graded on a three point scale using six variables (mouth opening, ease of LMA insertion, swallowing, coughing and gagging, head and body movements, laryngospasm). Each of these variables was rated as excellent, intermediate or poor.
Measured: at that time on LMA insertion only
Secondary outcomes (1)
Frequency of Apnea
If prolonged apnoea (> 30 s) developed, manual ventilation was assisted. And record the frequency of apnea on each group
Measured: baseline, 30sec after drug injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LaryngismusStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Jeong Kwak, Gachon University Gil Medical Center
- Investigators
- Jong Yeop Kim, MD,PhD, Study director, Ajou University School of MedicineJong Yeop Kim, MD, PhD, Study director, Ajou Universiy School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456299
- Sponsor's protocol ID
- AJIRB-MED-CT4-11-045
- Other IDs
- AJIRB-MED-CT4-11-045
- Status last verified
- Feb 2019
- First submitted
- 19 Oct 2011
- Last updated
- 15 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sivalingam P, Kandasamy R, Madhavan G, Dhakshinamoorthi P. Conditions for laryngeal mask insertion. A comparison of propofol versus sevoflurane with or without alfentanil. Anaesthesia. 1999 Mar;54(3):271-6. doi: 10.1046/j.1365-2044.1999.00663.x.
PubMed 10364865
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target-controlled Infusion of Remifentanil for Laryngeal Mask Airway Insertion During Sevoflurane Induction in Adults
- ClinicalTrials.gov ID
- NCT01456299
- Acronym / sponsor ID
- AJIRB-MED-CT4-11-045
- Conditions
- Laryngismus
- Keywords
- laryngeal mask airway, insertion, sevoflurane, remifentanil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Posted 4 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine the most suitable effect-site concentration of remifentanil for the LMA insertion during inhaled induction with 8% sevoflurane in adults.
Detailed description
For practical purposes, opioids with the ability to suppress upper airway reflexes have been used to facilitate insertion of the LMA during anaesthesia induction. To date, however, there have been no published reports addressing the use of remifentanil to facilitate LMA insertion during sevoflurane inhalation induction in adults. Therefore, the purpose of this study was to determine the most suitable effect-site concentration of remifentanil target-controlled infusion (TCI) for the LMA insertion during inhaled induction with 8% sevoflurane in adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: ControlThe control group, which received an infusion of normal saline. |
| Remifentanil 1 | Active comparator | Drug: Remifentanil 1"Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml. |
| Remifentanil 2 | Active comparator | Drug: Remifentanil 2"Remifentanil 2": "The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients, aged 18-60 with ASA physical status I or II, who were scheduled to minor elective surgery (< 1 h) were considered for the study
Key exclusion criteria (1 listed)
- Exclusion criteria were allergies to the study drugs, a history of gastric reflux, a history of drug abuse, obesity (body mass index > 30 kg/m2) and suspected 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 |
|---|---|---|
| Remifentanil 1Also: R1"Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml. | Drug | Remifentanil 1 |
| ControlAlso: PlaceboThe control group, which received an infusion of normal saline | Drug | Control |
| Remifentanil 2Also: R2"Remifentanil 2": "The R2group, which received a target effect-site remifentanil concentration of 2 ng/ml. | Drug | Remifentanil 2 |
Primary outcome
LMA Insertion Condition
Time frame: at that time on LMA insertion only
The pre-determined effect-site concentration of remifentanil or normal saline was administered according to the patient's group.LMAs were size #3 for women and #4 for men.The conditions of the LMA insertion were graded on a three point scale using six variables (mouth opening, ease of LMA insertion, swallowing, coughing and gagging, head and body movements, laryngospasm). Each of these variables was rated as excellent, intermediate or poor.
1 secondary outcome
Frequency of Apnea
Time frame: baseline, 30sec after drug injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10364865Sivalingam P, Kandasamy R, Madhavan G, Dhakshinamoorthi P. Conditions for laryngeal mask insertion. A comparison of propofol versus sevoflurane with or without alfentanil. Anaesthesia. 1999 Mar;54(3):271-6. doi: 10.1046/j.1365-2044.1999.00663.x.
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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.
Jong Yeop Kim, MD,PhD study director
Ajou University School of Medicine
Jong Yeop Kim, MD, PhD study director
Ajou Universiy School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil 1 and Remifentanil 2 in people with Laryngismus, run by Gachon University Gil Medical Center 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 1 inclusion and 1 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 Mar 2019. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
LMA Insertion Condition (time frame: at that time on LMA insertion only). 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 NCT01456299, 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 15 Mar 2019.