Patients Who Needs Sedation After Head & Neck SurgeryNCT03559920
The Optimal Dose of Sevoflurane Via Anaconda® in Post-operative Patient Underwent Head & Neck Surgery
A study testing Sedate using sevoflurane via anesthetic conserving device(ACD, Anaconda®) after surgery and Sedate using propofol. in people with Patients Who Needs Sedation After Head & Neck Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
Sedation in the ICUs is very common. There is no ideal sedative yet, so research has been conducted to replace propofol and midazolam, which are the most commonly used sedatives in ICUs, by inhalation anesthetics. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patients Who Needs Sedation After Head & Neck Surgery
- What is being tested?
- Sedate using sevoflurane via anesthetic conserving device(ACD, Anaconda®) after surgery and Sedate using propofol.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Apr 2018to 31 Mar 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who needs sedation in the ICU for several days after head \& neck surgery
- ASA class I~III
- Adult patients over 20 years old
- Patients who can read and understand the informed consent
Who cannot join
- Patients who do not agree to participate in the study
- Past history or Family history of malignant hyperthermia
- End stage renal disease (eGFR<30 or dialysis)
- Moderate to severe liver disease (AST, ALT > 200IU/L)
- Pregnant women
- Patients who cannot read and understand the informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 03722
About this study
Sedation in the ICUs is very common. There is no ideal sedative yet, so research has been conducted to replace propofol and midazolam, which are the most commonly used sedatives in ICUs, by inhalation anesthetics. The investigators will sedate the patients who undergo head \& neck surgery with tracheostomy for several days using sevoflurane, a kind of inhalation agent, via anesthetic conserving device.
The objective of this study is to confirm the end-tidal sevoflurane concentration for inducing moderate sedation (RASS -2~-3). In addition, the investigators compare the volatile sedation with the IV(intravenous) sedation to see if the volatile sedation could reduce the amount of post-operative opioid consumption.
- RASS: Richmond Agitation-Sedation Scale
- RASS: Richmond Agitation-Sedation Scale
Read the detailed description
When patients, who need mechanical ventilation for several days after head \& neck surgery, enters the ICU, the investigators induce moderate sedation (RASS -2~-3). End-tidal sevoflurane (etSEVO) concentration is adjusted to 0.5Vol% within 30 minutes. Sedation level is evaluated every 5 minutes. After 30 minutes, the investigators check that the sedation goal is achieved.
Following the up \& down method, if the moderate sedation (RASS -2~-3) or the deep sedation (RASS -4~-5) is achieved at the etSEVO concentration of 0.5vol% after 30 minutes of sedation, the next patient's target etSEVO concentration is reduced to 0.4vol%. On the contrary to this, if only light sedation (RASS above -1) is achieved, the next patient's target etSEVO is increased to 0.6vol%. This process is repeated to find the appropriate etSEVO concentration at the beginning of sedation, which induces sedation of RASS -2~-3.
In retrospective analysis, the investigators compared the prospective study group with propofol intravenous sedation group.
- RASS: Richmond Agitation-Sedation Scale
- Being tested
- Sedate using sevoflurane via anesthetic conserving device(ACD, Anaconda®) after surgery, Sedate using propofol.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedate using sevoflurane via anesthetic conserving device(ACD, Anaconda®) after surgeryDrug
The investigators sedate the patients in the ICU for several days after head \& neck surgery using sevoflurane via anesthetic conserving device in sevoflurane group.
Sedate using propofol.Drug
Retrospectively, the investigators compare the sevoflurane group with intravenous sedation group using propofol.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane group | Experimental | Patients who are sedated using sevoflurane Receives: Drug: Sedate using sevoflurane via anesthetic conserving device(ACD, Anaconda®) after surgery |
| Intravenous sedation group | Active comparator | Patients who are sedated using propofol Receives: Drug: Sedate using propofol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal end-tidal sevoflurane concentration to induce moderate sedation of RASS -2~-3 in patients who undergo head & neck surgery with tracheostomy
Investigators will find the initial concentration of sevoflurane for proper sedation by the Dixon's up and down method.
Measured: After the first 30 minutes after sedation with sevoflurane via anesthetic conserving device
Secondary outcomes (4)
Compare the sevoflurane group and the intravenous sedation group: Compare the ICU stay
Measured: within the 3 days (plus of minus 3 days) after surgery
Compare the sevoflurane group and the intravenous sedation group: Compare the hospital day
Measured: within the 3 days (plus of minus 3 days) after surgery
Compare the sevoflurane group and the intravenous sedation group: Compare the incidence of delirium, hypotension
Measured: within the 3 days (plus of minus 3 days) after surgery
Compare the sevoflurane group and the intravenous sedation group: Compare the remifentanil infusion dose
Measured: within the 3 days (plus of minus 3 days) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start3 Apr 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Who Needs Sedation After Head & Neck SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559920
- Sponsor's protocol ID
- 4-2018-0065
- Status last verified
- Feb 2020
- First submitted
- 1 Jun 2018
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Dose of Sevoflurane Via Anaconda® in Post-operative Patient Underwent Head & Neck Surgery
- ClinicalTrials.gov ID
- NCT03559920
- Acronym / sponsor ID
- 4-2018-0065
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 18 Jun 2018 (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.
Sedation in the ICUs is very common. There is no ideal sedative yet, so research has been conducted to replace propofol and midazolam, which are the most commonly used sedatives in ICUs, by inhalation anesthetics. The investigators will sedate the patients who undergo head \& neck surgery with tracheostomy for several days using sevoflurane, a kind of inhalation agent, via anesthetic conserving device.
The objective of this study is to confirm the end-tidal sevoflurane concentration for inducing moderate sedation (RASS -2~-3). In addition, the investigators compare the volatile sedation with the IV(intravenous) sedation to see if the volatile sedation could reduce the amount of post-operative opioid consumption.
- RASS: Richmond Agitation-Sedation Scale
- RASS: Richmond Agitation-Sedation Scale
Detailed description
When patients, who need mechanical ventilation for several days after head \& neck surgery, enters the ICU, the investigators induce moderate sedation (RASS -2~-3). End-tidal sevoflurane (etSEVO) concentration is adjusted to 0.5Vol% within 30 minutes. Sedation level is evaluated every 5 minutes. After 30 minutes, the investigators check that the sedation goal is achieved.
Following the up \& down method, if the moderate sedation (RASS -2~-3) or the deep sedation (RASS -4~-5) is achieved at the etSEVO concentration of 0.5vol% after 30 minutes of sedation, the next patient's target etSEVO concentration is reduced to 0.4vol%. On the contrary to this, if only light sedation (RASS above -1) is achieved, the next patient's target etSEVO is increased to 0.6vol%. This process is repeated to find the appropriate etSEVO concentration at the beginning of sedation, which induces sedation of RASS -2~-3.
In retrospective analysis, the investigators compared the prospective study group with propofol intravenous sedation group.
- RASS: Richmond Agitation-Sedation Scale
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane group | Experimental | Drug: Sedate using sevoflurane via anesthetic conserving device(ACD, Anaconda®) after surgeryPatients who are sedated using sevoflurane |
| Intravenous sedation group | Active comparator | Drug: Sedate using propofol.Patients who are sedated using propofol |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who needs sedation in the ICU for several days after head \& neck surgery
- ASA class I~III
- Adult patients over 20 years old
- Patients who can read and understand the informed consent
Key exclusion criteria (6 listed)
- Patients who do not agree to participate in the study
- Past history or Family history of malignant hyperthermia
- End stage renal disease (eGFR<30 or dialysis)
- Moderate to severe liver disease (AST, ALT > 200IU/L)
- Pregnant women
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 |
|---|---|---|
| Sedate using sevoflurane via anesthetic conserving device(ACD, Anaconda®) after surgeryThe investigators sedate the patients in the ICU for several days after head \& neck surgery using sevoflurane via anesthetic conserving device in sevoflurane group. | Drug | Sevoflurane group |
| Sedate using propofol.Retrospectively, the investigators compare the sevoflurane group with intravenous sedation group using propofol. | Drug | Intravenous sedation group |
Primary outcome
Optimal end-tidal sevoflurane concentration to induce moderate sedation of RASS -2~-3 in patients who undergo head & neck surgery with tracheostomy
Time frame: After the first 30 minutes after sedation with sevoflurane via anesthetic conserving device
Investigators will find the initial concentration of sevoflurane for proper sedation by the Dixon's up and down method.
4 secondary outcomes
Compare the sevoflurane group and the intravenous sedation group: Compare the ICU stay
Time frame: within the 3 days (plus of minus 3 days) after surgery
Compare the sevoflurane group and the intravenous sedation group: Compare the hospital day
Time frame: within the 3 days (plus of minus 3 days) after surgery
Compare the sevoflurane group and the intravenous sedation group: Compare the incidence of delirium, hypotension
Time frame: within the 3 days (plus of minus 3 days) after surgery
Compare the sevoflurane group and the intravenous sedation group: Compare the remifentanil infusion dose
Time frame: within the 3 days (plus of minus 3 days) after surgery
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 6 Feb 2020.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedate using sevoflurane via anesthetic conserving device(ACD, Anaconda®) after surgery and Sedate using propofol. in people with Patients Who Needs Sedation After Head & Neck Surgery, run by Yonsei University 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 4 inclusion and 6 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 6 Feb 2020. 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. 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?
Optimal end-tidal sevoflurane concentration to induce moderate sedation of RASS -2~-3 in patients who undergo head & neck surgery with tracheostomy (time frame: After the first 30 minutes after sedation with sevoflurane via anesthetic conserving device). 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 6 Feb 2020.