AnaesthesiaSACRPNCT02920749
Study of Anaesthesia Costs and Recovery Profiles
A study testing Sevoflurane group A, Sevoflurane group B and Propofol group C in people with Anaesthesia, run by University of Pecs at 1 site in Hungary.
Trial summary
The purpose of this study is to compare the perioperative hemodynamic parameters, recovery profiles and cost containment of sevoflurane and propofol based general anesthesia for otorhinolaryngeal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anaesthesia
- What is being tested?
- Sevoflurane group A, Sevoflurane group B and Propofol group C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHungary
- Study dates
- Sep 2014to Oct 2016
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA physical status grade I or II who were scheduled for elective otorhinolaryngological surgery.
Who cannot join
- Individuals with a history of bronchial asthma, chronic obstructive pulmonary disease, epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recovery Profiles and Costs in Sevoflurane and Propofol Based Anaesthesia
The purpose of this study is to compare the perioperative hemodynamic parameters, recovery profiles and cost containment of sevoflurane and propofol based general anesthesia for otorhinolaryngeal surgery.
Read the detailed description
Sevoflurane and propofol are two basic drugs in the maintenance of anaesthesia. In this study we compared the perioperative hemodynamic parameters, recovery profiles and cost containment of sevoflurane and propofol based general anaesthesia for otorhinolaryngeal surgery. Patients were equally divided into four anaesthetic subgroups. In groups A and C anaesthesia was based on sevoflurane or propofol, respectively, without bispectral index (BIS) and train-of-for monitor (TOF) monitoring. In groups B and D anaesthesia was based on sevoflurane or propofol, respectively, with BIS and TOF monitoring. Drug consumption, recovery profiles and anaesthesia costs were analysed.
ECG, main arterial pressure (MAP), heart rate, oxygen saturation of peripheral haemoglobin (SpO2), pressure of end-tidal carbon dioxide was monitored continuously and registered at 5 min intervals during anaesthesia. Each group received propofol for anaesthesia induction. In group A and B anaesthesia was maintained with sevoflurane, in groups C and D with propofol. In groups B and D the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) were monitored too. BIS and TOF values were recorded at 5 min intervals.
- Conditions
- Anaesthesia
- Being tested
- Sevoflurane group A, Sevoflurane group B, Propofol group C, Propofol group D
- Keywords
- anaesthesia, costs, recovery profiles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane group ADrug
Also called Sevorane anaesthesia
In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane dosing was adjusted for the same MAP range.
Sevoflurane group BDrug
Also called Sevorane anaesthesia with BIS and TOF monitoring
In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg.
Propofol group CDrug
Also called Propofol anaesthesia
In this group anaesthesia was maintained with propofol. Propofol was administered according to protocol. Propofol dosing was adjusted for the same MAP range.
Propofol group DDrug
Also called Propofol anaesthesia with BIS and TOF monitoring
In this group anaesthesia was maintained with propofol. Propofol dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane group A | Other | Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture. Receives: Drug: Sevoflurane group A |
| Sevoflurane group B | Other | Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture. Sevoflurane dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Receives: Drug: Sevoflurane group B |
| Propofol group C | Other | During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Receives: Drug: Propofol group C |
| Propofol group D | Other | Propofol dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Receives: Drug: Propofol group D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Consumption
drugs of sevoflurane or total intravenous anaesthesia without or with BIS and TOF monitoring : fentanyl, sevoflurane, propofol 1%, atracurium in milligrams
Measured: at induction one dose and during anaesthesia mg/1 hour
Secondary outcomes (1)
Costs of Anaesthesia
total cost of drugs (midazolam, propofol 1%, sevoflurane, atracurium, diclofenac, nalbuphin and antidotes) and disposable cost in euros
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startSep 2014
- Primary completionOct 2016
- Study completionOct 2016
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 (1)Papers the sponsor has linked to this study.
- Other trials for AnaesthesiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timea Bocskai, University of Pecs
- Investigators
- Csaba Loibl, MD, Study chair, Department of Anesthesiology and Intensive Therapy, University of Pecs, HungaryZoltan Vamos, MD, PhD, Study chair, Department of Anesthesiology and Intensive Therapy, University of Pecs, HungaryGabor Woth, MD, PhD, Study chair, Department of Anesthesiology and Intensive Therapy, University of Pecs, HungaryLajos Bogar, MD, PhD, DSc, Study director, Department of Anesthesiology and Intensive Therapy, University of Pecs, HungaryLaszlo Lujber, MD, PhD, Study director, Department of Otorhinolaryngology, University of Pecs, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920749
- Sponsor's protocol ID
- 316-2336/KK15
- Acronym
- SACRP
- Status last verified
- Feb 2018
- First submitted
- 25 Sep 2016
- Last updated
- 6 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data of primary outcome measures will be made available within one month of study completion
Publications
Bocskai T, Loibl C, Vamos Z, Woth G, Molnar T, Bogar L, Lujber L. Cost-effectiveness of anesthesia maintained with sevoflurane or propofol with and without additional monitoring: a prospective, randomized controlled trial. BMC Anesthesiol. 2018 Jul 28;18(1):100. doi: 10.1186/s12871-018-0563-z.
PubMed 30055562
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Profiles and Costs in Sevoflurane and Propofol Based Anaesthesia
- ClinicalTrials.gov ID
- NCT02920749
- Acronym / sponsor ID
- SACRP / 316-2336/KK15
- Conditions
- Anaesthesia
- Keywords
- anaesthesia, costs, recovery profiles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Posted 6 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the perioperative hemodynamic parameters, recovery profiles and cost containment of sevoflurane and propofol based general anesthesia for otorhinolaryngeal surgery.
Detailed description
Sevoflurane and propofol are two basic drugs in the maintenance of anaesthesia. In this study we compared the perioperative hemodynamic parameters, recovery profiles and cost containment of sevoflurane and propofol based general anaesthesia for otorhinolaryngeal surgery. Patients were equally divided into four anaesthetic subgroups. In groups A and C anaesthesia was based on sevoflurane or propofol, respectively, without bispectral index (BIS) and train-of-for monitor (TOF) monitoring. In groups B and D anaesthesia was based on sevoflurane or propofol, respectively, with BIS and TOF monitoring. Drug consumption, recovery profiles and anaesthesia costs were analysed.
ECG, main arterial pressure (MAP), heart rate, oxygen saturation of peripheral haemoglobin (SpO2), pressure of end-tidal carbon dioxide was monitored continuously and registered at 5 min intervals during anaesthesia. Each group received propofol for anaesthesia induction. In group A and B anaesthesia was maintained with sevoflurane, in groups C and D with propofol. In groups B and D the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) were monitored too. BIS and TOF values were recorded at 5 min intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane group A | Other | Drug: Sevoflurane group AAnaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture. |
| Sevoflurane group B | Other | Drug: Sevoflurane group BAnaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture. Sevoflurane dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. |
| Propofol group C | Other | Drug: Propofol group CDuring anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). |
| Propofol group D | Other | Drug: Propofol group DPropofol dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status grade I or II who were scheduled for elective otorhinolaryngological surgery.
Key exclusion criteria (1 listed)
- Individuals with a history of bronchial asthma, chronic obstructive pulmonary disease, epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease.
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 |
|---|---|---|
| Sevoflurane group AAlso: Sevorane anaesthesiaIn this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane dosing was adjusted for the same MAP range. | Drug | Sevoflurane group A |
| Sevoflurane group BAlso: Sevorane anaesthesia with BIS and TOF monitoringIn this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. | Drug | Sevoflurane group B |
| Propofol group CAlso: Propofol anaesthesiaIn this group anaesthesia was maintained with propofol. Propofol was administered according to protocol. Propofol dosing was adjusted for the same MAP range. | Drug | Propofol group C |
| Propofol group DAlso: Propofol anaesthesia with BIS and TOF monitoringIn this group anaesthesia was maintained with propofol. Propofol dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. | Drug | Propofol group D |
Primary outcome
Drug Consumption
Time frame: at induction one dose and during anaesthesia mg/1 hour
drugs of sevoflurane or total intravenous anaesthesia without or with BIS and TOF monitoring : fentanyl, sevoflurane, propofol 1%, atracurium in milligrams
1 secondary outcome
Costs of Anaesthesia
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30055562Bocskai T, Loibl C, Vamos Z, Woth G, Molnar T, Bogar L, Lujber L. Cost-effectiveness of anesthesia maintained with sevoflurane or propofol with and without additional monitoring: a prospective, randomized controlled trial. BMC Anesthesiol. 2018 Jul 28;18(1):100. doi: 10.1186/s12871-018-0563-z.
- Individual participant dataSharing planned: Yes. Data of primary outcome measures will be made available within one month of study completion
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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.
Csaba Loibl, MD study chair
Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary
Zoltan Vamos, MD, PhD study chair
Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary
Gabor Woth, MD, PhD study chair
Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane group A, Sevoflurane group B and Propofol group C in people with Anaesthesia, run by University of Pecs at 1 site in Hungary.
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 1 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 Feb 2018. 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 Hungary. 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. 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?
Yes. Results are posted in the registry (first posted 6 Dec 2016). 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?
Drug Consumption (time frame: at induction one dose and during anaesthesia mg/1 hour). 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 NCT02920749, which also lists 1 linked publication.
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 Feb 2018.