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

Study Overview

• Status: Completed
• Conditions: Patients Who Needs Sedation After Head & Neck Surgery
• Intervention / Treatment: Drug: Sedate using sevoflurane via anesthetic conserving device(ACD, Anaconda®) after surgery; Drug: Sedate using propofol.

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sevoflurane group; Patients who are sedated using sevoflurane	Drug: Sedate 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.
Active Comparator: Intravenous sedation group; Patients who are sedated using propofol	Drug: Sedate using propofol.; Retrospectively, the investigators compare the sevoflurane group with intravenous sedation group using propofol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After the first 30 minutes after sedation with sevoflurane via anesthetic conserving device

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare the sevoflurane group and the intravenous sedation group: Compare the ICU stay	within the 3 days (plus of minus 3 days) after surgery
Compare the sevoflurane group and the intravenous sedation group: Compare the hospital day	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	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	within the 3 days (plus of minus 3 days) after surgery

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2018
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Anesthetics; Propofol; Sevoflurane
• Other Study ID Numbers: 4-2018-0065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No