Delayed Emergence From AnesthesiaPhase 4NCT02631525
Recovery Profile Comparison Between Remifentanil-propofol or Desflurane Anesthesia Monitored With Bispectral Index.
A Phase 4 study testing Desflurane and Propofol in people with Delayed Emergence From Anesthesia, run by Federal University of Minas Gerais.
Trial summary
Bispectral monitoring anesthesia with remifentanil-desflurane has a better post-operative recovery than remifentanil-propofol. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Delayed Emergence From Anesthesia
- What is being tested?
- Desflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of: illegal drug and alcohol abuse
- Pregnancy on course or suspicion of
- Neuromuscular disorders
- Cerebral vascular disease
- Dysphagia
- Dysphonia
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- 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.
About this study
Official title: A Comparison of Post-operative Recovery Between Remifentanil-propofol and Remifentanil-desflurane Anesthesia Guided by Bispectral Index Monitoring
Bispectral monitoring anesthesia with remifentanil-desflurane has a better post-operative recovery than remifentanil-propofol.
Read the 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.
- Conditions
- Delayed Emergence From Anesthesia
- Being tested
- Desflurane, Propofol
- Keywords
- Airway extubation, Anesthesia Recovery Period, Desflurane, Propofol, Intravenous anesthesia, Balanced Anesthesia
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring
PropofolDrug
Also called Diprivan
Total intravenous anesthesia based on propofol
| Study group | Role | What they receive |
|---|---|---|
| REM-PRO | Active comparator | Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models. Receives: Drug: Propofol |
| REM-DES | Active comparator | Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation Time
Time from anesthetic discontinuation to endotracheal tube cuff deflation
Measured: Time from anesthetic discontinuation to endotracheal tube cuff deflation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startAug 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Delayed Emergence From AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Medtronic - MITG
- Responsible party
- Principal investigator, Renato Santiago Gomez, Federal University of Minas Gerais
- Investigators
- Renato S Gomez, PhD, Principal investigator, Professor of the Medicine School of the Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631525
- Sponsor's protocol ID
- CAAE - 31820014.8.0000.5149
- Status last verified
- Aug 2020
- First submitted
- 4 Dec 2015
- Last updated
- 25 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25211391Mckay 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.
PubMed 15728054Wachtel 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.
PubMed 21630118Punjasawadwong 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.
PubMed 24937564
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Post-operative Recovery Between Remifentanil-propofol and Remifentanil-desflurane Anesthesia Guided by Bispectral Index Monitoring
- ClinicalTrials.gov ID
- NCT02631525
- Acronym / sponsor ID
- CAAE - 31820014.8.0000.5149
- Conditions
- Delayed Emergence From Anesthesia
- Keywords
- Airway extubation, Anesthesia Recovery Period, Desflurane, Propofol, Intravenous anesthesia, Balanced Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Medtronic - MITG
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Posted 25 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REM-PRO | Active comparator | Drug: PropofolTotal intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models. |
| REM-DES | Active comparator | Drug: DesfluraneBalanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- History of: illegal drug and alcohol abuse
- Pregnancy on course or suspicion of
- Neuromuscular disorders
- Cerebral vascular disease
- Dysphagia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesfluraneBalanced anesthesia with remifentanil and desflurane guided by bispectral monitoring | Drug | REM-DES |
| PropofolAlso: DiprivanTotal intravenous anesthesia based on propofol | Drug | REM-PRO |
Primary outcome
Extubation Time
Time frame: Time from anesthetic discontinuation to endotracheal tube cuff deflation
Time from anesthetic discontinuation to endotracheal tube cuff deflation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25211391Wu 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.
- Background: PubMed 15728054Mckay 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.
- Background: PubMed 21630118Wachtel 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.
- Background: PubMed 24937564Punjasawadwong 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renato S Gomez, PhD principal investigator
Professor of the Medicine School of the Federal University of Minas Gerais
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desflurane and Propofol in people with Delayed Emergence From Anesthesia, run by Federal University of Minas Gerais.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation Time (time frame: Time from anesthetic discontinuation to endotracheal tube cuff deflation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02631525, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.