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Recovery Profile Comparison Between Remifentanil-propofol or Desflurane Anesthesia Monitored With Bispectral Index.

Primary Purpose

Delayed Emergence From Anesthesia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Desflurane
Propofol
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delayed Emergence From Anesthesia focused on measuring Airway extubation, Anesthesia Recovery Period, Desflurane, Propofol, Intravenous anesthesia, Balanced Anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female patients over 18 years old classified by the American Society of Anesthesiologists as physical status I or II, undergoing elective breast surgery with general anesthesia.

Exclusion Criteria:

  • History of: illegal drug and alcohol abuse
  • Pregnancy on course or suspicion of
  • Neuromuscular disorders
  • Cerebral vascular disease
  • Dysphagia
  • Dysphonia
  • Gastroesophageal reflux disease
  • Previous larynx and/or upper gastrointestinal tract surgery
  • Allergy to any drug to be used and malignant hyperthermia.
  • Patients who develop hemodynamic instability in the surgery and need blood transfusion were excluded from the study.
  • Patients unable to swallow 20 ml of water in an upright position were also excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    REM-PRO

    REM-DES

    Arm Description

    Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models.

    Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.

    Outcomes

    Primary Outcome Measures

    Extubation Time
    Time from anesthetic discontinuation to endotracheal tube cuff deflation

    Secondary Outcome Measures

    Full Information

    First Posted
    December 4, 2015
    Last Updated
    August 11, 2020
    Sponsor
    Federal University of Minas Gerais
    Collaborators
    Baxter Healthcare Corporation, Medtronic - MITG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02631525
    Brief Title
    Recovery Profile Comparison Between Remifentanil-propofol or Desflurane Anesthesia Monitored With Bispectral Index.
    Official Title
    A Comparison of Post-operative Recovery Between Remifentanil-propofol and Remifentanil-desflurane Anesthesia Guided by Bispectral Index Monitoring
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2014 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Minas Gerais
    Collaborators
    Baxter Healthcare Corporation, Medtronic - MITG

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Bispectral monitoring anesthesia with remifentanil-desflurane has a better post-operative recovery than remifentanil-propofol.
    Detailed Description
    It is a randomized, double blind study, involving 40 adult female patients submitted to general anesthesia. The patients were distributed into 2 groups: remifentanil-propofol-based anesthesia and remifentanil-desflurane-based anesthesia groups. Bispectral index (BIS) monitoring guided the anesthesia by setting target BIS range value between 40 and 60. Anesthetics were adjusted to reached that. Primary outcome was: extubation time (time from anesthetic discontinuation to endotracheal tube cuff). Secondary measured outcomes: intra-operative cardiovascular drug use; time to follow command before extubation; protective airway reflex recovery time after extubation. Protective airway reflex test recovery was performed at predetermined time intervals (2, 6, 14, 22 and 30 minutes) from the time to follow a standard command until the first demonstrated ability to swallow 20 ml of water in an upright position.Post-anesthesia care unit recovery data were also recorded: Ramsay sedation scale; vital signs, post-operative pain; morphine consumption.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delayed Emergence From Anesthesia
    Keywords
    Airway extubation, Anesthesia Recovery Period, Desflurane, Propofol, Intravenous anesthesia, Balanced Anesthesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    REM-PRO
    Arm Type
    Active Comparator
    Arm Description
    Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models.
    Arm Title
    REM-DES
    Arm Type
    Active Comparator
    Arm Description
    Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.
    Intervention Type
    Drug
    Intervention Name(s)
    Desflurane
    Intervention Description
    Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring
    Intervention Type
    Drug
    Intervention Name(s)
    Propofol
    Other Intervention Name(s)
    Diprivan
    Intervention Description
    Total intravenous anesthesia based on propofol
    Primary Outcome Measure Information:
    Title
    Extubation Time
    Description
    Time from anesthetic discontinuation to endotracheal tube cuff deflation
    Time Frame
    Time from anesthetic discontinuation to endotracheal tube cuff deflation

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female patients over 18 years old classified by the American Society of Anesthesiologists as physical status I or II, undergoing elective breast surgery with general anesthesia. Exclusion Criteria: History of: illegal drug and alcohol abuse Pregnancy on course or suspicion of Neuromuscular disorders Cerebral vascular disease Dysphagia Dysphonia Gastroesophageal reflux disease Previous larynx and/or upper gastrointestinal tract surgery Allergy to any drug to be used and malignant hyperthermia. Patients who develop hemodynamic instability in the surgery and need blood transfusion were excluded from the study. Patients unable to swallow 20 ml of water in an upright position were also excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Renato S Gomez, PhD
    Organizational Affiliation
    Professor of the Medicine School of the Federal University of Minas Gerais
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    25211391
    Citation
    Wu ZF, Jian GS, Lee MS, Lin C, Chen YF, Chen YW, Huang YS, Cherng CH, Lu CH. An analysis of anesthesia-controlled operating room time after propofol-based total intravenous anesthesia compared with desflurane anesthesia in ophthalmic surgery: a retrospective study. Anesth Analg. 2014 Dec;119(6):1393-406. doi: 10.1213/ANE.0000000000000435.
    Results Reference
    background
    PubMed Identifier
    15728054
    Citation
    Mckay RE, Large MJC, Balea MC, Mckay WR. Airway reflexes return more rapidly after desflurane anesthesia than after sevoflurane anesthesia. Anesth Analg. 2005 Mar;100(3):697-700. doi: 10.1213/01.ANE.0000146514.65070.AE.
    Results Reference
    background
    PubMed Identifier
    21630118
    Citation
    Wachtel RE, Dexter F, Epstein RH, Ledolter J. Meta-analysis of desflurane and propofol average times and variability in times to extubation and following commands. Can J Anaesth. 2011 Aug;58(8):714-24. doi: 10.1007/s12630-011-9519-1. Epub 2011 Jun 1.
    Results Reference
    background
    PubMed Identifier
    24937564
    Citation
    Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3.
    Results Reference
    background

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    Recovery Profile Comparison Between Remifentanil-propofol or Desflurane Anesthesia Monitored With Bispectral Index.

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