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The Optimal Dose of Sevoflurane Via Anaconda® in Post-operative Patient Underwent Head & Neck Surgery

The Optimal Dose of Sevoflurane Via Anaconda® in Post-operative Patient Underwent Head & Neck Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03559920
Enrollment
49
Registered
2018-06-18
Start date
2018-04-03
Completion date
2019-03-31
Last updated
2020-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Who Needs Sedation After Head & Neck Surgery

Brief 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. 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

Interventions

DRUGSedate using sevoflurane via anesthetic conserving device(ACD, Anaconda®) after surgery

The investigators sedate the patients in the ICU for several days after head & neck surgery using sevoflurane via anesthetic conserving device in sevoflurane group.

DRUGSedate using propofol.

Retrospectively, the investigators compare the sevoflurane group with intravenous sedation group using propofol.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Optimal end-tidal sevoflurane concentration to induce moderate sedation of RASS -2~-3 in patients who undergo head & neck surgery with tracheostomyAfter the first 30 minutes after sedation with sevoflurane via anesthetic conserving deviceInvestigators will find the initial concentration of sevoflurane for proper sedation by the Dixon's up and down method.

Secondary

MeasureTime frame
Compare the sevoflurane group and the intravenous sedation group: Compare the ICU staywithin the 3 days (plus of minus 3 days) after surgery
Compare the sevoflurane group and the intravenous sedation group: Compare the hospital daywithin the 3 days (plus of minus 3 days) after surgery
Compare the sevoflurane group and the intravenous sedation group: Compare the incidence of delirium, hypotensionwithin the 3 days (plus of minus 3 days) after surgery
Compare the sevoflurane group and the intravenous sedation group: Compare the remifentanil infusion dosewithin the 3 days (plus of minus 3 days) after surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026