Anesthesia, GeneralLoFADSNCT07016308
Low-Flow Desflurane vs Sevoflurane: Impact on Physiology and Recoveryand Recovery Profiles in Adult ENT Surgery
A study testing Sevoflurane and Desflurane in people with Anesthesia, General, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
This randomized, double-blind, controlled clinical trial aims to compare the effects of low-flow sevoflurane and desflurane anesthesia on physiological parameters and recovery profiles in adult patients undergoing ENT surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Sevoflurane and Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2025to 15 Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged between 18 and 65 years
- Classified as ASA physical status I or II
- Scheduled to undergo elective ENT surgery (rhinoplasty, mastoidectomy, or tympanoplasty)
- Requiring general anesthesia with endotracheal intubation
- Providing written informed consent
Who cannot join
- ASA physical status III or higher
- History of malignant hyperthermia or delayed emergence from anesthesia
- Morbid obesity (BMI ≥ 35)
- Coronary artery disease, congestive heart failure, COPD, liver or kidney disease
- Pregnancy or breastfeeding
- Allergy to halogenated anesthetics
- Respiratory pathology
- Substance or alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Low-Flow Desflurane and Sevoflurane Anesthesia on Physiological Parameters and Recovery Process
This randomized, double-blind, controlled clinical trial aims to compare the effects of low-flow sevoflurane and desflurane anesthesia on physiological parameters and recovery profiles in adult patients undergoing ENT surgeries. The primary outcomes include heart rate, mean arterial pressure, peripheral oxygen saturation, end-tidal CO₂, and arterial blood gas values. Secondary outcomes involve time to spontaneous respiration, extubation, and response to verbal commands.
Read the detailed description
This prospective study investigates the clinical effects of low-flow anesthesia using two commonly utilized volatile agents, sevoflurane and desflurane, in adult patients undergoing elective ENT surgeries, specifically rhinoplasty, mastoidectomy, and tympanoplasty. A total of 40 ASA I-II patients, aged 18-65, will be randomly assigned into two groups: Group S (sevoflurane) and Group D (desflurane).
All participants will undergo general anesthesia with endotracheal intubation. After 2 minutes of preoxygenation with 100% oxygen at 10 L/min, anesthesia will be induced and maintained with the assigned volatile agent under low-flow settings (1 L/min, 50% O₂-50% air). Hemodynamic and respiratory parameters (HR, MAP, SpO₂, EtCO₂) will be recorded at predefined time points, along with arterial blood gas analysis (pH, pCO₂, pO₂, COHb).
Recovery times including return of spontaneous respiration, extubation, and verbal response will be documented. This study aims to provide clinical evidence on the optimal anesthetic choice under low-flow conditions, supporting safer, more efficient, and environmentally conscious anesthesia practices.
- Conditions
- Anesthesia, General
- Being tested
- Sevoflurane, Desflurane
- Keywords
- Sevoflurane, Desflurane, Low-flow anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Sevoflurane will be administered via inhalation under low-flow anesthesia conditions. The concentration will be maintained at 2-3% (0.8-1 MAC) with a fresh gas flow of 1 L/min (50% oxygen and 50% air) after induction. Used in Group S (Sevoflurane Low-Flow Anesthesia Arm).
DesfluraneDrug
Also called Suprane
Desflurane will be administered via inhalation under low-flow anesthesia conditions. The concentration will be maintained at 4-6% (0.8-1 MAC) with a fresh gas flow of 1 L/min (50% oxygen and 50% air) after induction. Used in Group D (Desflurane Low-Flow Anesthesia Arm).
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane Low-Flow Anesthesia | Experimental | Participants in this group will receive general anesthesia using sevoflurane administered under low-flow conditions. After standard induction and intubation, sevoflurane will be maintained at 2-3% (0.8-1 MAC) with a fresh gas flow of 1 L/min (50% oxygen / 50% air). Vital signs and arterial blood gases will be monitored, and recovery parameters such as time to spontaneous breathing, extubation, and verbal response will be recorded. Receives: Drug: Sevoflurane; Drug: Desflurane |
| Desflurane Low-Flow Anesthesia | Active comparator | Participants in this group will receive general anesthesia using desflurane administered under low-flow conditions. After standard induction and intubation, desflurane will be maintained at 4-6% (0.8-1 MAC) with a fresh gas flow of 1 L/min (50% oxygen / 50% air). Hemodynamic and respiratory parameters as well as arterial blood gases and recovery times will be evaluated and compared to the sevoflurane group. Receives: Drug: Sevoflurane; Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate During Surgery
Heart rate (HR) will be measured at baseline, post-intubation, and at 15, 30, 45, 60, and 120 minutes after anesthesia induction.
Measured: From preoperative baseline to 120 minutes after anesthesia induction
Change in Mean Arterial Pressure During Surgery
Mean arterial pressure (MAP) will be recorded at the same predefined time intervals during surgery.
Measured: From preoperative baseline to 120 minutes after induction
Change in End-Tidal CO₂
End-tidal carbon dioxide (EtCO₂) levels will be monitored during surgery at specified intervals.
Measured: From preoperative baseline to 120 minutes after induction
Change in Peripheral Oxygen Saturation
Peripheral oxygen saturation (SpO₂) will be measured at baseline, post-intubation, and intraoperative time points.
Measured: From preoperative baseline to 120 minutes after induction
Secondary outcomes (2)
Change in Arterial pH
Arterial blood gas samples will be analyzed for pH at baseline, 60 and 120 minutes, and at end of surgery.
Measured: Preoperative, intraoperative (60 and 120 min), end of surgery
Post-Anesthesia Recovery Times
Time to return of spontaneous respiration, time to extubation, and time to follow verbal commands will be recorded.
Measured: From end of surgery until recovery (within approx. 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start10 Jun 2025
- Primary completion19 Nov 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies 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
- Model description
- Participants will be randomly assigned to receive either low-flow sevoflurane or low-flow desflurane anesthesia.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veli Fahri Pehlivan, Harran University
- Investigators
- Basak Pehlivan, Asoc Prof. Dr, Principal investigator, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016308
- Sponsor's protocol ID
- Ceren
- Acronym
- LoFADS
- Status last verified
- Feb 2026
- First submitted
- 30 May 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low-Flow Desflurane and Sevoflurane Anesthesia on Physiological Parameters and Recovery Process
- ClinicalTrials.gov ID
- NCT07016308
- Acronym / sponsor ID
- LoFADS / Ceren
- Conditions
- Anesthesia, General
- Keywords
- Sevoflurane, Desflurane, Low-flow anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 11 Jun 2025 (actual)
- 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.
This randomized, double-blind, controlled clinical trial aims to compare the effects of low-flow sevoflurane and desflurane anesthesia on physiological parameters and recovery profiles in adult patients undergoing ENT surgeries. The primary outcomes include heart rate, mean arterial pressure, peripheral oxygen saturation, end-tidal CO₂, and arterial blood gas values. Secondary outcomes involve time to spontaneous respiration, extubation, and response to verbal commands.
Detailed description
This prospective study investigates the clinical effects of low-flow anesthesia using two commonly utilized volatile agents, sevoflurane and desflurane, in adult patients undergoing elective ENT surgeries, specifically rhinoplasty, mastoidectomy, and tympanoplasty. A total of 40 ASA I-II patients, aged 18-65, will be randomly assigned into two groups: Group S (sevoflurane) and Group D (desflurane).
All participants will undergo general anesthesia with endotracheal intubation. After 2 minutes of preoxygenation with 100% oxygen at 10 L/min, anesthesia will be induced and maintained with the assigned volatile agent under low-flow settings (1 L/min, 50% O₂-50% air). Hemodynamic and respiratory parameters (HR, MAP, SpO₂, EtCO₂) will be recorded at predefined time points, along with arterial blood gas analysis (pH, pCO₂, pO₂, COHb).
Recovery times including return of spontaneous respiration, extubation, and verbal response will be documented. This study aims to provide clinical evidence on the optimal anesthetic choice under low-flow conditions, supporting safer, more efficient, and environmentally conscious anesthesia practices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to receive either low-flow sevoflurane or low-flow desflurane anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane Low-Flow Anesthesia | Experimental | Drug: Sevoflurane, Drug: DesfluraneParticipants in this group will receive general anesthesia using sevoflurane administered under low-flow conditions. After standard induction and intubation, sevoflurane will be maintained at 2-3% (0.8-1 MAC) with a fresh gas flow of 1 L/min (50% oxygen / 50% air). Vital signs and arterial blood gases will be monitored, and recovery parameters such as time to spontaneous breathing, extubation, and verbal response will be recorded. |
| Desflurane Low-Flow Anesthesia | Active comparator | Drug: Sevoflurane, Drug: DesfluraneParticipants in this group will receive general anesthesia using desflurane administered under low-flow conditions. After standard induction and intubation, desflurane will be maintained at 4-6% (0.8-1 MAC) with a fresh gas flow of 1 L/min (50% oxygen / 50% air). Hemodynamic and respiratory parameters as well as arterial blood gases and recovery times will be evaluated and compared to the sevoflurane group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged between 18 and 65 years
- Classified as ASA physical status I or II
- Scheduled to undergo elective ENT surgery (rhinoplasty, mastoidectomy, or tympanoplasty)
- Requiring general anesthesia with endotracheal intubation
- Providing written informed consent
Key exclusion criteria (8 listed)
- ASA physical status III or higher
- History of malignant hyperthermia or delayed emergence from anesthesia
- Morbid obesity (BMI ≥ 35)
- Coronary artery disease, congestive heart failure, COPD, liver or kidney disease
- Pregnancy or breastfeeding
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 will be administered via inhalation under low-flow anesthesia conditions. The concentration will be maintained at 2-3% (0.8-1 MAC) with a fresh gas flow of 1 L/min (50% oxygen and 50% air) after induction. Used in Group S (Sevoflurane Low-Flow Anesthesia Arm). | Drug | Desflurane Low-Flow Anesthesia, Sevoflurane Low-Flow Anesthesia |
| DesfluraneAlso: SupraneDesflurane will be administered via inhalation under low-flow anesthesia conditions. The concentration will be maintained at 4-6% (0.8-1 MAC) with a fresh gas flow of 1 L/min (50% oxygen and 50% air) after induction. Used in Group D (Desflurane Low-Flow Anesthesia Arm). | Drug | Desflurane Low-Flow Anesthesia, Sevoflurane Low-Flow Anesthesia |
Primary outcome
Change in Heart Rate During Surgery
Time frame: From preoperative baseline to 120 minutes after anesthesia induction
Heart rate (HR) will be measured at baseline, post-intubation, and at 15, 30, 45, 60, and 120 minutes after anesthesia induction.
Change in Mean Arterial Pressure During Surgery
Time frame: From preoperative baseline to 120 minutes after induction
Mean arterial pressure (MAP) will be recorded at the same predefined time intervals during surgery.
Change in End-Tidal CO₂
Time frame: From preoperative baseline to 120 minutes after induction
End-tidal carbon dioxide (EtCO₂) levels will be monitored during surgery at specified intervals.
Change in Peripheral Oxygen Saturation
Time frame: From preoperative baseline to 120 minutes after induction
Peripheral oxygen saturation (SpO₂) will be measured at baseline, post-intubation, and intraoperative time points.
2 secondary outcomes
Change in Arterial pH
Time frame: Preoperative, intraoperative (60 and 120 min), end of surgery
Post-Anesthesia Recovery Times
Time frame: From end of surgery until recovery (within approx. 30 minutes)
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 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Basak Pehlivan, Asoc Prof. Dr principal investigator
Harran University
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 and Desflurane in people with Anesthesia, General, run by Harran 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 5 inclusion and 8 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 27 Feb 2026. 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.
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?
Change in Heart Rate During Surgery (time frame: From preoperative baseline to 120 minutes after anesthesia induction). The study lists 4 primary outcomes in all. 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 27 Feb 2026.