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

NCT ID: NCT03559920

Last Updated: 2020-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-03
• Study Completion Date: 2019-03-31

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

Conditions

Patients Who Needs Sedation After Head & Neck Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sevoflurane group

Patients who are sedated using sevoflurane

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Intravenous sedation group

Patients who are sedated using propofol

Group Type: ACTIVE_COMPARATOR

Sedate using propofol.

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Sedate using propofol.

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2018-0065

Identifier Type: -

Identifier Source: org_study_id