Appropriate AffectNCT04664595
Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices
A study testing Propofol Fresenius in people with Appropriate Affect and Complication of Device Insertion, run by Prince of Songkla University at 2 sites in Thailand.
Trial summary
to evaluate and compare the effect-site concentration of propofol with the TCI system for second-generation SGA device insertion between the I-gel™, Supreme™, ProSeal™ and Laryngeal Tube Suction II™. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Appropriate Affect, Complication of Device Insertion
- What is being tested?
- Propofol Fresenius
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesThailand
- Study dates
- Jun 2012to Dec 2013
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-III patients.
- Patients 18-70 years old .
- Patients scheduled for general anesthesia for elective non-cardiac surgery with SGA devices.
Who cannot join
- Adults with a potentially difficult airway (cervical spine disease, Mallampati classification IV, or a mouth opening less than 2.5 cm.).
- Adults with reactive airway disease.
- Adults with signs of respiratory infection or a plan to remain intubated were excluded from the study.
- Excluded patients who had a risk of gastric aspiration or morbid obesity (body mass index > 35 kg/m2).
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Price of Songkla University
Hat Yai, Changwat Songkhla, 90110
Songklanagarind Hospital
Hat Yai, Changwat Songkhla, 90110
About this study
to evaluate and compare the effect-site concentration of propofol with the TCI system for second-generation SGA device insertion between the I-gel™, Supreme™, ProSeal™ and Laryngeal Tube Suction II™.
to determine the hemodynamic changes during insertion of supraglottic devices in patients undergoing elective surgery and any complications after device insertion.
Read the detailed description
The investigators enrolled ASA physical status I-III patients who were 18-70 years old and scheduled for general anesthesia for elective non-cardiac surgery with SGA devices.Adults with a potentially difficult airway (cervical spine disease, Mallampati classification IV, or a mouth opening less than 2.5 cm.), reactive airway disease, signs of respiratory infection or a plan to remain intubated were excluded from the study. The investigators also excluded patients who had a risk of gastric aspiration or morbid obesity (body mass index > 35 kg/m2).
Patients were randomized into 4 groups (I-gel™, Supreme™, ProSeal™ and Laryngeal Tube Suction II™ SGAs) according to a computer generated randomization list and patients were allocated consecutively. The sample size of each group required 10 patients.
All patients were pre-oxygenated with 100% oxygen. After the administration of 2 µg/ml intravenous fentanyl for 5 minutes, anesthesia was induced with the Schnider pharmacokinetic TCI system. After equilibration of the plasma-site and effect-site concentrations in propofol TCI, 1 of the 4 types of SGA was randomly inserted by two anesthesiologists (resident trainee and staff doctor) who were unaware of the actual plasma concentration of propofol without the use of a muscle relaxant.
The response of each patient determined the effect-site concentration of propofol of the next patient. "No Response" was defined as Laryngeal Mask Airway Insertion Score = 0 and "Response" was defined as Laryngeal Mask Airway Insertion Score ≥ 1. If the insertion of the supraglottic airway device was successful ("No Response"), then the target effect-site concentration was decreased by a step of 0.4 µg/ml. If the insertion failed ("Response"), the target effect-site concentration was increased by the same dose. The patients' responses to LMA insertion was classified by blinded investigators.
- Being tested
- Propofol Fresenius
- Keywords
- Target Controlled Infusion, Supraglottic airway device, Propofol, Supreme™, ProSeal™, I-gel™, Laryngeal Tube Suction II™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol FreseniusDrug
final dose of Propofol (mcg/kg) to reach the target effect-site concentration
| Study group | Role | What they receive |
|---|---|---|
| Group SP | Sham comparator | The Supreme™ group Receives: Drug: Propofol Fresenius |
| Group PS | Active comparator | The ProSeal™ group Receives: Drug: Propofol Fresenius |
| Group IG | Active comparator | The I-gel™ group Receives: Drug: Propofol Fresenius |
| Group LT | Active comparator | The Laryngeal Tube Suction IITM group Receives: Drug: Propofol Fresenius |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of propofol for supragloqtic airway devices insertion
The effect-site concentration of propofol required to insert supraglottic airway devices.
Measured: 2 years
Secondary outcomes (1)
Blood pressure changes from baseline after insertion of supraglottic devices
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study startJun 2012
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appropriate AffectStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4 second generation of supraglottic airway device
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nalinee Kovitwanawong, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664595
- Sponsor's protocol ID
- 55-213-08-1-2
- Status last verified
- Aug 2021
- First submitted
- 2 Sep 2014
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices
- ClinicalTrials.gov ID
- NCT04664595
- Acronym / sponsor ID
- 55-213-08-1-2
- Keywords
- Target Controlled Infusion, Supraglottic airway device, Propofol, Supreme™, ProSeal™, I-gel™, Laryngeal Tube Suction II™
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Dec 2020 (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.
to evaluate and compare the effect-site concentration of propofol with the TCI system for second-generation SGA device insertion between the I-gel™, Supreme™, ProSeal™ and Laryngeal Tube Suction II™.
to determine the hemodynamic changes during insertion of supraglottic devices in patients undergoing elective surgery and any complications after device insertion.
Detailed description
The investigators enrolled ASA physical status I-III patients who were 18-70 years old and scheduled for general anesthesia for elective non-cardiac surgery with SGA devices.Adults with a potentially difficult airway (cervical spine disease, Mallampati classification IV, or a mouth opening less than 2.5 cm.), reactive airway disease, signs of respiratory infection or a plan to remain intubated were excluded from the study. The investigators also excluded patients who had a risk of gastric aspiration or morbid obesity (body mass index > 35 kg/m2).
Patients were randomized into 4 groups (I-gel™, Supreme™, ProSeal™ and Laryngeal Tube Suction II™ SGAs) according to a computer generated randomization list and patients were allocated consecutively. The sample size of each group required 10 patients.
All patients were pre-oxygenated with 100% oxygen. After the administration of 2 µg/ml intravenous fentanyl for 5 minutes, anesthesia was induced with the Schnider pharmacokinetic TCI system. After equilibration of the plasma-site and effect-site concentrations in propofol TCI, 1 of the 4 types of SGA was randomly inserted by two anesthesiologists (resident trainee and staff doctor) who were unaware of the actual plasma concentration of propofol without the use of a muscle relaxant.
The response of each patient determined the effect-site concentration of propofol of the next patient. "No Response" was defined as Laryngeal Mask Airway Insertion Score = 0 and "Response" was defined as Laryngeal Mask Airway Insertion Score ≥ 1. If the insertion of the supraglottic airway device was successful ("No Response"), then the target effect-site concentration was decreased by a step of 0.4 µg/ml. If the insertion failed ("Response"), the target effect-site concentration was increased by the same dose. The patients' responses to LMA insertion was classified by blinded investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 4 second generation of supraglottic airway device
| Arm | Type | Receives |
|---|---|---|
| Group SP | Sham comparator | Drug: Propofol FreseniusThe Supreme™ group |
| Group PS | Active comparator | Drug: Propofol FreseniusThe ProSeal™ group |
| Group IG | Active comparator | Drug: Propofol FreseniusThe I-gel™ group |
| Group LT | Active comparator | Drug: Propofol FreseniusThe Laryngeal Tube Suction IITM group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status I-III patients.
- Patients 18-70 years old .
- Patients scheduled for general anesthesia for elective non-cardiac surgery with SGA devices.
Key exclusion criteria (4 listed)
- Adults with a potentially difficult airway (cervical spine disease, Mallampati classification IV, or a mouth opening less than 2.5 cm.).
- Adults with reactive airway disease.
- Adults with signs of respiratory infection or a plan to remain intubated were excluded from the study.
- Excluded patients who had a risk of gastric aspiration or morbid obesity (body mass index > 35 kg/m2).
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 Freseniusfinal dose of Propofol (mcg/kg) to reach the target effect-site concentration | Drug | Group IG, Group LT, Group PS, Group SP |
Primary outcome
Tolerability of propofol for supragloqtic airway devices insertion
Time frame: 2 years
The effect-site concentration of propofol required to insert supraglottic airway devices.
1 secondary outcome
Blood pressure changes from baseline after insertion of supraglottic devices
Time frame: 2 years
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 23 Aug 2021.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol Fresenius in people with Appropriate Affect and Complication of Device Insertion, run by Prince of Songkla University at 2 sites 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 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 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Tolerability of propofol for supragloqtic airway devices insertion (time frame: 2 years). 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 23 Aug 2021.