AnesthesiaPhase 4NCT02379715
Effect-site Concentration of Remifentanil for Smooth Induction With Desflurane
A Phase 4 study testing Remifentanil and Desflurane in people with Anesthesia, run by Ajou University School of Medicine.
Trial summary
Desflurane is a halogenated ether with low solubility, giving rapid induction and emergence from anesthesia This character is suitable for Volatile Induction and Maintenance Anesthesia (VIMA). Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Remifentanil and Desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to May 2015
- 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients for surgery requiring general anesthesia
- American Society of Anesthesiologists(ASA) classification I, II
Who cannot join
- history of gastroesophageal reflux, High grade obesity, Predicted difficult airway, Asthma, Chronic obstructive pulmonary disease(COPD), Upper respiratory infection (URI) within 3 weeks
About this study
Desflurane is a halogenated ether with low solubility, giving rapid induction and emergence from anesthesia This character is suitable for Volatile Induction and Maintenance Anesthesia (VIMA). But desflurane can cause airway irritation when it used as a sole induction agent to adult or children, so there were many studies about reducing the airway reflex combined with desflurane.
Remifentanil is a short acting opioid and is quickly hydrolyzed by nonspecific esterase in the plasma and multiorgan. Several studies suggest the optimal dose of remifentanil for reducing airway reflex or cardiovascular response for intubation combined with desflurane. But these studies were under 1 Minimal Alveolar Concentration (MAC) of desflurane and this point could be a limitation because desflurane concentration over 1 MAC increase airway irritation significantly. This study this study was designed to determine a median effective effect-site concentration (EC50) of remifentanil to prevent airway irritation during desflurane anesthesia over 1 MAC.
- Conditions
- Anesthesia
- Being tested
- Remifentanil, Desflurane
- Keywords
- Remifentanil, smooth induction, desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Ultiva
DesfluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Experimental | When the particapants arrived into the operating room, the investigators applied standard monitoring and after preoxygenation, 2 mg remifentanil was diluted into 50 ml of normal saline (40 μg/ml solution) and was infused by Target concentration infusion (TCI) via syringe pump (Pilot Anesthesia 2. Fresenius vial, France) using the pharmacokinetic model. Investigator started to infuse remifentanil at 4 ng/ml and after the Ce of remifentanil reached the target concentration level, opened the dial of desflurane vaporizer at 4 vol%. After 30 seconds, increase the concentration of desflurane 8% and 12% at last. If there is no spontaneous respiration or loss of consciousness, the muscle relaxant esmerone 0.6mg/kg is injected and after 90 seconds the tracheal intubation is performed. Receives: Drug: Remifentanil; Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fail or success for induction with desflurane
Failure for induction with desflurane is defined if there is a cough, laryngospasm, hypoxia or any refusal movement of patient.
Measured: After loss of consciousness, 5 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiyoung Yoo, Ajou University School of Medicine
- Investigators
- Yoonjeong Chae, MD, Study chair, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379715
- Sponsor's protocol ID
- AJIRB-MED-CT4-14-327
- Status last verified
- Aug 2020
- First submitted
- 27 Jan 2015
- Last updated
- 20 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect-site Concentration of Remifentanil for Smooth Induction With Desflurane
- ClinicalTrials.gov ID
- NCT02379715
- Acronym / sponsor ID
- AJIRB-MED-CT4-14-327
- Conditions
- Anesthesia
- Keywords
- Remifentanil, smooth induction, desflurane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 5 Mar 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.
Desflurane is a halogenated ether with low solubility, giving rapid induction and emergence from anesthesia This character is suitable for Volatile Induction and Maintenance Anesthesia (VIMA). But desflurane can cause airway irritation when it used as a sole induction agent to adult or children, so there were many studies about reducing the airway reflex combined with desflurane.
Remifentanil is a short acting opioid and is quickly hydrolyzed by nonspecific esterase in the plasma and multiorgan. Several studies suggest the optimal dose of remifentanil for reducing airway reflex or cardiovascular response for intubation combined with desflurane. But these studies were under 1 Minimal Alveolar Concentration (MAC) of desflurane and this point could be a limitation because desflurane concentration over 1 MAC increase airway irritation significantly. This study this study was designed to determine a median effective effect-site concentration (EC50) of remifentanil to prevent airway irritation during desflurane anesthesia over 1 MAC.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Experimental | Drug: Remifentanil, Drug: DesfluraneWhen the particapants arrived into the operating room, the investigators applied standard monitoring and after preoxygenation, 2 mg remifentanil was diluted into 50 ml of normal saline (40 μg/ml solution) and was infused by Target concentration infusion (TCI) via syringe pump (Pilot Anesthesia 2. Fresenius vial, France) using the pharmacokinetic model. Investigator started to infuse remifentanil at 4 ng/ml and after the Ce of remifentanil reached the target concentration level, opened the dial of desflurane vaporizer at 4 vol%. After 30 seconds, increase the concentration of desflurane 8% and 12% at last. If there is no spontaneous respiration or loss of consciousness, the muscle relaxant esmerone 0.6mg/kg is injected and after 90 seconds the tracheal intubation is performed. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients for surgery requiring general anesthesia
- American Society of Anesthesiologists(ASA) classification I, II
Key exclusion criteria (1 listed)
- history of gastroesophageal reflux, High grade obesity, Predicted difficult airway, Asthma, Chronic obstructive pulmonary disease(COPD), Upper respiratory infection (URI) within 3 weeks
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 |
|---|---|---|
| RemifentanilAlso: Ultiva | Drug | Remifentanil |
| Desflurane | Drug | Remifentanil |
Primary outcome
Fail or success for induction with desflurane
Time frame: After loss of consciousness, 5 seconds
Failure for induction with desflurane is defined if there is a cough, laryngospasm, hypoxia or any refusal movement of patient.
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 20 Aug 2020.
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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.
Yoonjeong Chae, MD study chair
Ajou University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil and Desflurane in people with Anesthesia, run by Ajou University School of Medicine.
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 2 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 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Fail or success for induction with desflurane (time frame: After loss of consciousness, 5 seconds). 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 20 Aug 2020.