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Completed

NCT Number: NCT03559920

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

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 18, 2018
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.