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

Patients Who Needs Sedation After Head & Neck Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03559920
• Other study ID #: 4-2018-0065
• Status: Completed
• Phase: N/A
• Start date: April 3, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: February 2020
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patients Who Needs Sedation After Head & Neck Surgery

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare the sevoflurane group and the intravenous sedation group: Compare the ICU stay		within the 3 days (plus of minus 3 days) after surgery
Secondary	Compare the sevoflurane group and the intravenous sedation group: Compare the hospital day		within the 3 days (plus of minus 3 days) after surgery
Secondary	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
Secondary	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