Oxygen SaturationPhase 4NCT02834845
Comparison of Volatile Anesthetics on Cerebral Oxygenation During Controlled Hypotension
A Phase 4 study testing Sevoflurane and Desflurane in people with Oxygen Saturation, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
Controlled hypotension is a preferred method for reducing surgical bleeding during septoplasty operations however, the level of hypotension and bradycardia should not disrupt cerebral oxygenation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Oxygen Saturation
- What is being tested?
- Sevoflurane and Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2016to Aug 2016
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in American Society of Anesthesiology (ASA) classification I and II
- Patients undergoing elective septoplasty operation
Who cannot join
- Patients in ASA classification III and higher
- Emergency surgery
- Patients in New York Heart Association classification III-IV
- Patients with known allergy to drugs used in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effects of Sevoflurane and Desflurane on Cerebral Oxygenation During Controlled Hypotension
Controlled hypotension is a preferred method for reducing surgical bleeding during septoplasty operations however, the level of hypotension and bradycardia should not disrupt cerebral oxygenation. On this account, the investigators aim to investigate the effects of different volatile anesthetics combined with a short-acting opioid on cerebral oxygenation during controlled hypotension using near infrared spectroscopy.
- Conditions
- Oxygen Saturation
- Being tested
- Sevoflurane, Desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Sevoflurane %2-3 for general anesthesia maintenance
DesfluraneDrug
Desflurane %6-8 for general anesthesia maintenance
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | Not described Receives: Drug: Sevoflurane |
| Desflurane | Experimental | Not described Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral oxygen saturation as measured by Near Infrared Spectroscopy
The effect of sevoflurane and desflurane on NIRS values
Measured: Duration of surgery
Secondary outcomes (4)
Total remifentanil consumption as measured in micrograms
Measured: Duration of surgery
The effect of anesthetics on hemodynamic variables
The effects of sevoflurane and desflurane on mean arterial pressure
Measured: Duration of surgery
The effect of anesthetics on hemodynamic variables
The effects of sevoflurane and desflurane on heart rate
Measured: Duration of surgery
The effect of anesthetics on hemodynamic variables
The effects of sevoflurane and desflurane on bispectral index
Measured: Duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen SaturationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Perihan Ekmekçi, Ufuk University
- Investigators
- Ülkü C Köksoy, MD, Principal investigator, Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834845
- Sponsor's protocol ID
- 2016Sept
- Status last verified
- Aug 2020
- First submitted
- 24 Jun 2016
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Sevoflurane and Desflurane on Cerebral Oxygenation During Controlled Hypotension
- ClinicalTrials.gov ID
- NCT02834845
- Acronym / sponsor ID
- 2016Sept
- Conditions
- Oxygen Saturation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Jul 2016 (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.
Controlled hypotension is a preferred method for reducing surgical bleeding during septoplasty operations however, the level of hypotension and bradycardia should not disrupt cerebral oxygenation. On this account, the investigators aim to investigate the effects of different volatile anesthetics combined with a short-acting opioid on cerebral oxygenation during controlled hypotension using near infrared spectroscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: Sevoflurane |
| Desflurane | Experimental | Drug: Desflurane |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients in American Society of Anesthesiology (ASA) classification I and II
- Patients undergoing elective septoplasty operation
Key exclusion criteria (4 listed)
- Patients in ASA classification III and higher
- Emergency surgery
- Patients in New York Heart Association classification III-IV
- Patients with known allergy to drugs used in the study
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 |
|---|---|---|
| SevofluraneSevoflurane %2-3 for general anesthesia maintenance | Drug | Sevoflurane |
| DesfluraneDesflurane %6-8 for general anesthesia maintenance | Drug | Desflurane |
Primary outcome
Cerebral oxygen saturation as measured by Near Infrared Spectroscopy
Time frame: Duration of surgery
The effect of sevoflurane and desflurane on NIRS values
4 secondary outcomes
Total remifentanil consumption as measured in micrograms
Time frame: Duration of surgery
The effect of anesthetics on hemodynamic variables
Time frame: Duration of surgery
The effect of anesthetics on hemodynamic variables
Time frame: Duration of surgery
The effect of anesthetics on hemodynamic variables
Time frame: Duration of surgery
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 19 Aug 2020.
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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.
Ülkü C Köksoy, MD principal investigator
Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane and Desflurane in people with Oxygen Saturation, run by Ufuk University at 1 site in Turkey (Türkiye).
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 4 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 19 Aug 2020. 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 Turkey (Türkiye). 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.
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?
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?
Cerebral oxygen saturation as measured by Near Infrared Spectroscopy (time frame: Duration of surgery). 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 19 Aug 2020.