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
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
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
NCT ID
NCT02631525
First Posted
December 4, 2015
Last Updated
August 11, 2020
Sponsor
Federal University of Minas Gerais
Collaborators
Baxter Healthcare Corporation, Medtronic - MITG
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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