Adverse Effect of Other General AnestheticsNCT02157428
Effect of Flumazenil on Recovery From General Anesthesia With Isoflurane
A study testing Flumazenil and saline in people with Adverse Effect of Other General Anesthetics, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Background and objectives: The inhalational anesthetic isoflurane is widely used in general anesthetics. Its mechanism of action involves interaction with the receptor of gamma-amino butyric acid (GABA), which is also the binding site for benzodiazepines. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Effect of Other General Anesthetics
- What is being tested?
- Flumazenil and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients scheduled to surgeries with general anesthesia,
- healthy or with minor diseases completely controlled by regular use of medications (ASA I or II according to the classification of physical state by the American Society of Anesthesiologists).
Who cannot join
- patients with past of chronic use of benzodiazepines and/or illicit drugs,
- seizures or panic disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Flumazenil on Recovery From General Anesthesia With Isoflurane: a Randomized Controlled Trial
Background and objectives: The inhalational anesthetic isoflurane is widely used in general anesthetics. Its mechanism of action involves interaction with the receptor of gamma-amino butyric acid (GABA), which is also the binding site for benzodiazepines. Flumazenil, benzodiazepine antagonist, reverses the effects of these drugs in GABA receptors and could therefore also reverse the effect of isoflurane. In anesthesia practice, extubation and early anesthetic recovery reduce morbidity and incidence of complications. The objective of this trial is to determine whether the use of flumazenil may contribute to faster recovery from anesthesia. Methods: 40 patients scheduled to undergo general anesthesia with isoflurane were enrolled in this prospective, double-blind, randomized trial. Patients were randomized to receive, at the end of anesthesia, flumazenil or placebo as allocated into two groups. The anesthetic technique was standardized. The groups were compared concerning values of Cerebral State Index (CSI), heart rate, blood pressure and oxygen saturation from the application of flumazenil or placebo until 30 minutes after injection. Data regarding time to extubation, time to reach ten points in the Aldrete-Kroulic score (AK = 10) and Vigilance score (VS = 10) was also collected. ANOVA test was applied to analyze the results, considering p <0.05.
- Being tested
- Flumazenil, saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlumazenilDrug
salineDrug
| Study group | Role | What they receive |
|---|---|---|
| saline | Placebo comparator | patients received 20 ml of saline during 1 minute, after end of surgery. Receives: Drug: saline |
| flumazenil | Active comparator | patients received 1 mg of flumazenil, after end of surgery Receives: Drug: Flumazenil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of recovery from a general anesthesia isoflurane based
Measured: up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJan 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Effect of Other General AnestheticsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Domingos Dias Cicarelli, MD, PhD, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157428
- Sponsor's protocol ID
- 984/10
- Status last verified
- Jun 2014
- First submitted
- 1 Jun 2014
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Flumazenil on Recovery From General Anesthesia With Isoflurane: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02157428
- Acronym / sponsor ID
- 984/10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and objectives: The inhalational anesthetic isoflurane is widely used in general anesthetics. Its mechanism of action involves interaction with the receptor of gamma-amino butyric acid (GABA), which is also the binding site for benzodiazepines. Flumazenil, benzodiazepine antagonist, reverses the effects of these drugs in GABA receptors and could therefore also reverse the effect of isoflurane. In anesthesia practice, extubation and early anesthetic recovery reduce morbidity and incidence of complications. The objective of this trial is to determine whether the use of flumazenil may contribute to faster recovery from anesthesia. Methods: 40 patients scheduled to undergo general anesthesia with isoflurane were enrolled in this prospective, double-blind, randomized trial. Patients were randomized to receive, at the end of anesthesia, flumazenil or placebo as allocated into two groups. The anesthetic technique was standardized. The groups were compared concerning values of Cerebral State Index (CSI), heart rate, blood pressure and oxygen saturation from the application of flumazenil or placebo until 30 minutes after injection. Data regarding time to extubation, time to reach ten points in the Aldrete-Kroulic score (AK = 10) and Vigilance score (VS = 10) was also collected. ANOVA test was applied to analyze the results, considering p <0.05.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saline | Placebo comparator | Drug: salinepatients received 20 ml of saline during 1 minute, after end of surgery. |
| flumazenil | Active comparator | Drug: Flumazenilpatients received 1 mg of flumazenil, after end of surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients scheduled to surgeries with general anesthesia,
- healthy or with minor diseases completely controlled by regular use of medications (ASA I or II according to the classification of physical state by the American Society of Anesthesiologists).
Key exclusion criteria (2 listed)
- patients with past of chronic use of benzodiazepines and/or illicit drugs,
- seizures or panic disorder.
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 |
|---|---|---|
| Flumazenil | Drug | flumazenil |
| saline | Drug | saline |
Primary outcome
Time of recovery from a general anesthesia isoflurane based
Time frame: up to 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flumazenil and saline in people with Adverse Effect of Other General Anesthetics, run by University of Sao Paulo at 1 site in Brazil.
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 2 inclusion and 2 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 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time of recovery from a general anesthesia isoflurane based (time frame: up to 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2014.