Patients Requiring Ambulatory Surgery Under General AnesthesiaPhase 4SC50NCT01974648
Propofol for Supreme LMA Insertion With and Without Remifentanil
A Phase 4 study testing propofol and propofol and remifentanil in people with Patients Requiring Ambulatory Surgery Under General Anesthesia, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
The aims of this study were to determine the clinically required concentration of propofol for LMA Supreme insertion, and to examine to what extent remifentanil reduces the dose of propofol and improves conditions for it's insertion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients Requiring Ambulatory Surgery Under General Anesthesia
- What is being tested?
- propofol and propofol and remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSpain
- Study dates
- May 2012to Jun 2013
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ASA II-II patients Scheduled to ambulatory surgery Need of general anaesthesia General anaesthesia usually performed with laryngeal mask Negative pregnancy test in women. Signed informed consent.
Who cannot join
- Patients with a potentially difficult airway o (Mallampati III or IV, a limited mouth opening and/or cervical spine disease) Patients with reactive airway disease Signs of upper respiratory infection, Patients who had a risk of gastric aspiration
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital General Universitario Gregorio Marañon Servicio de Anestesiologia y Reanimación
Madrid, Madrid, 28007
About this study
Official title: ED 50 of Propofol for Supreme LMA Insertion With and Without Remifentanil. A Randomized Trial
The aims of this study were to determine the clinically required concentration of propofol for LMA Supreme insertion, and to examine to what extent remifentanil reduces the dose of propofol and improves conditions for it's insertion.
Read the detailed description
The single-use Laryngeal Mask Airway SupremeTM (SLMA, Laryngeal Mask Company Limited, Singapore) is a new single use supraglottic airway device introduced recently that present combined features of the LMA ProSealTM (PLMA, Laryngeal Mask Company Limited) and the LMA FastrachTM (FLMA, Laryngeal Mask Company Limited). The mask has an anatomically shaped airway tube, elliptical in cross-section that facilitates easy insertion and minimizes accidental rotation. The cuff bowl is designed to prevent airway kinking and offer higher airway seal pressures around the laryngeal opening than the LMA ClassicTM (CLMA, Laryngeal Mask Company Limited) It has a drain tube that provides functional separation of the respiratory and digestive tracts to prevent gastric aspiration. Even though insertion of the SLMA is associated with a higher initial success rate, fewer airway manipulations and a safe and effective airway during anaesthesia, the anaesthetic techniques for its insertion were not standardised. Most available data on the requirements of anaesthetic drugs and co-induction agents used for insertion of SLMA originate from research involving other assessments of the SLMA such as the seal with respiratory and gastrointestinal tract.We tested for differences in the predicted concentration of propofol with and without remifentanil for insertion of the SLMA.
Methods: 50 patients ASA class I or II aged 18-75 years undergoing ambulatory elective surgery will be randomized to one of two groups: those who receive propofol + saline (control group: n = 25) or propofol + remifentanil (propofol-remifentanil group: n=25). We will use target-controled infusions (Alaris®PK) for both drugs: propofol (Marsh et al.´s pharmacokinetic model) and remifentanil (Minto et al.´s pharmacokinetic model). The patients wil be premedicated with midazolam 1 mg iv before surgery. The target concentration for each patient was determined using the Dixon´s up-and-down method. Predetermined propofol and remifentanil blood and effect site concentrations were held constant for at least 10 min. After equilibration of plasma and effect site propofol concentrations, the SLMA will be inserted, and secured according to the manufacture´s recommendations, without the use of muscle relaxants. In control group, propofol concentrations will start at 4 μg ml-1, with 0,5 μg ml-1 as the step size, with the coadministration of saline. In propofol-remifentanil group, propofol + remifentanil at a target-controlled infusion 5 ng/mL will be coadministered. A single measurement will be obtained from each patient. If the patient reacted with movement, the propofol concentration for the next patient was increased by 0.5 μg ml-1 ±1 ; if there was no movement, it was decreased by 0.5 μg ml-1 ±1 . Movement was defined as bucking or gross purposeful muscular movement within 1 min of LMA insertion. Values of Cp 50 wil be determined by calculating the midpoint concentration after at least seven crossover points (movement/non movement) will be obtained in each group.
- Being tested
- propofol, propofol and remifentanil
- Keywords
- Laryngeal Mask Airway Supreme, propofol, remifentanil, effective dose of intravenous propofol, ED50
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
propofol and remifentanilDrug
| Study group | Role | What they receive |
|---|---|---|
| propofol | Active comparator | In control group, propofol concentrations will start at 4 μg ml-1, with 0,5 μg ml-1 as the step size, with the coadministration of saline. Receives: Drug: propofol |
| propofol and remifentanil | Experimental | In propofol-remifentanil group, propofol + remifentanil at a target-controlled infusion 5 ng/mL will be coadministered. Receives: Drug: propofol and remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentration of propofol with and without remifentanil for insertion of the SLMA
Comparison of he concentration of propofol with and without remifentanil for insertion of the SLMA
Measured: at insertion of SLMA
Secondary outcomes (5)
changes in Systolic Blood Pressure, Diastolic Blood Pressure and Heart Rate
Measured: basal and every 3 minutes until 6 minutes after insertion of the SLMA
BIS
BIS data after SLMA insertion with both anaesthetic techniques
Measured: before and after SLMA insertion(every min until min 6)
Fibrescope evaluation
Fibrescope evaluation of the SLMA Of the view of the glottis
Measured: after SLMA insertion
blood pressure(Hypertension or hypotension)
Measured: before and after SLMA insertion(every min until min 6)
heart rate (tachycardia or bradycardia)
tachycardia or bradycardia requiring treatment
Measured: before and after SLMA insertion(every min until min 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startMay 2012
- Primary completionJun 2013
- Study completionJun 2013
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 Patients Requiring Ambulatory Surgery Under General AnesthesiaStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Spain
- Responsible party
- Sponsor
- Investigators
- Matilde Zaballos, PhD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974648
- Sponsor's protocol ID
- FIBHGMECNC002-2011
- Acronym
- SC50
- Status last verified
- Oct 2013
- First submitted
- 21 Oct 2013
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Zaballos M, Bastida E, Agusti S, Portas M, Jimenez C, Lopez-Gil M. Effect-site concentration of propofol required for LMA-Supreme insertion with and without remifentanil: a randomized controlled trial. BMC Anesthesiol. 2015 Oct 6;15:131. doi: 10.1186/s12871-015-0115-8.
PubMed 26438179
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED 50 of Propofol for Supreme LMA Insertion With and Without Remifentanil. A Randomized Trial
- ClinicalTrials.gov ID
- NCT01974648
- Acronym / sponsor ID
- SC50 / FIBHGMECNC002-2011
- Keywords
- Laryngeal Mask Airway Supreme, propofol, remifentanil, effective dose of intravenous propofol, ED50
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Collaborators
- Ministry of Health, Spain
- Study start
- May 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Nov 2013 (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 aims of this study were to determine the clinically required concentration of propofol for LMA Supreme insertion, and to examine to what extent remifentanil reduces the dose of propofol and improves conditions for it's insertion.
Detailed description
The single-use Laryngeal Mask Airway SupremeTM (SLMA, Laryngeal Mask Company Limited, Singapore) is a new single use supraglottic airway device introduced recently that present combined features of the LMA ProSealTM (PLMA, Laryngeal Mask Company Limited) and the LMA FastrachTM (FLMA, Laryngeal Mask Company Limited). The mask has an anatomically shaped airway tube, elliptical in cross-section that facilitates easy insertion and minimizes accidental rotation. The cuff bowl is designed to prevent airway kinking and offer higher airway seal pressures around the laryngeal opening than the LMA ClassicTM (CLMA, Laryngeal Mask Company Limited) It has a drain tube that provides functional separation of the respiratory and digestive tracts to prevent gastric aspiration. Even though insertion of the SLMA is associated with a higher initial success rate, fewer airway manipulations and a safe and effective airway during anaesthesia, the anaesthetic techniques for its insertion were not standardised. Most available data on the requirements of anaesthetic drugs and co-induction agents used for insertion of SLMA originate from research involving other assessments of the SLMA such as the seal with respiratory and gastrointestinal tract.We tested for differences in the predicted concentration of propofol with and without remifentanil for insertion of the SLMA.
Methods: 50 patients ASA class I or II aged 18-75 years undergoing ambulatory elective surgery will be randomized to one of two groups: those who receive propofol + saline (control group: n = 25) or propofol + remifentanil (propofol-remifentanil group: n=25). We will use target-controled infusions (Alaris®PK) for both drugs: propofol (Marsh et al.´s pharmacokinetic model) and remifentanil (Minto et al.´s pharmacokinetic model). The patients wil be premedicated with midazolam 1 mg iv before surgery. The target concentration for each patient was determined using the Dixon´s up-and-down method. Predetermined propofol and remifentanil blood and effect site concentrations were held constant for at least 10 min. After equilibration of plasma and effect site propofol concentrations, the SLMA will be inserted, and secured according to the manufacture´s recommendations, without the use of muscle relaxants. In control group, propofol concentrations will start at 4 μg ml-1, with 0,5 μg ml-1 as the step size, with the coadministration of saline. In propofol-remifentanil group, propofol + remifentanil at a target-controlled infusion 5 ng/mL will be coadministered. A single measurement will be obtained from each patient. If the patient reacted with movement, the propofol concentration for the next patient was increased by 0.5 μg ml-1 ±1 ; if there was no movement, it was decreased by 0.5 μg ml-1 ±1 . Movement was defined as bucking or gross purposeful muscular movement within 1 min of LMA insertion. Values of Cp 50 wil be determined by calculating the midpoint concentration after at least seven crossover points (movement/non movement) will be obtained in each group.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Active comparator | Drug: propofolIn control group, propofol concentrations will start at 4 μg ml-1, with 0,5 μg ml-1 as the step size, with the coadministration of saline. |
| propofol and remifentanil | Experimental | Drug: propofol and remifentanilIn propofol-remifentanil group, propofol + remifentanil at a target-controlled infusion 5 ng/mL will be coadministered. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ASA II-II patients Scheduled to ambulatory surgery Need of general anaesthesia General anaesthesia usually performed with laryngeal mask Negative pregnancy test in women. Signed informed consent.
Key exclusion criteria (1 listed)
- Patients with a potentially difficult airway o (Mallampati III or IV, a limited mouth opening and/or cervical spine disease) Patients with reactive airway disease Signs of upper respiratory infection, Patients who had a risk of gastric aspiration
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 |
|---|---|---|
| propofol | Drug | propofol |
| propofol and remifentanil | Drug | propofol and remifentanil |
Primary outcome
The concentration of propofol with and without remifentanil for insertion of the SLMA
Time frame: at insertion of SLMA
Comparison of he concentration of propofol with and without remifentanil for insertion of the SLMA
5 secondary outcomes
changes in Systolic Blood Pressure, Diastolic Blood Pressure and Heart Rate
Time frame: basal and every 3 minutes until 6 minutes after insertion of the SLMA
BIS
Time frame: before and after SLMA insertion(every min until min 6)
Fibrescope evaluation
Time frame: after SLMA insertion
blood pressure(Hypertension or hypotension)
Time frame: before and after SLMA insertion(every min until min 6)
heart rate (tachycardia or bradycardia)
Time frame: before and after SLMA insertion(every min until min 6)
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 1 Nov 2013.
- Derived from this study: PubMed 26438179Zaballos M, Bastida E, Agusti S, Portas M, Jimenez C, Lopez-Gil M. Effect-site concentration of propofol required for LMA-Supreme insertion with and without remifentanil: a randomized controlled trial. BMC Anesthesiol. 2015 Oct 6;15:131. doi: 10.1186/s12871-015-0115-8.
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.
Matilde Zaballos, PhD principal investigator
Hospital General Universitario Gregorio Marañon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol and propofol and remifentanil in people with Patients Requiring Ambulatory Surgery Under General Anesthesia, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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 1 Nov 2013. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The concentration of propofol with and without remifentanil for insertion of the SLMA (time frame: at insertion of SLMA). 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 NCT01974648, 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 1 Nov 2013.