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

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ClinicalTrials.gov Identifier: NCT03559920
Recruitment Status : Completed
First Posted : June 18, 2018
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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

Condition or disease Intervention/treatment Phase
Patients Who Needs Sedation After Head & Neck Surgery Drug: Sedate using sevoflurane via anesthetic conserving device(ACD, Anaconda®) after surgery Drug: Sedate using propofol. Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Optimal Dose of Sevoflurane Via Anaconda® in Post-operative Patient Underwent Head & Neck Surgery
Actual Study Start Date : April 3, 2018
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559920


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03559920    
Other Study ID Numbers: 4-2018-0065
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Propofol
Sevoflurane
Anesthetics
Hypnotics and Sedatives
Central Nervous System Depressants
 Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation