General AnesthesiaNCT07511634
Comparison of Sevoflurane and Desflurane on ANI in Patients Undergoing General Anesthesia: a Prospective Randomized Controlled Study
A study testing Desflurane and Sevoflurane in people with General Anesthesia, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
This prospective randomized controlled study will compare the effects of sevoflurane and desflurane on the Analgesia Nociception Index (ANI) in adult patients undergoing general anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Desflurane and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 to 79 years
- Patients undergoing general anesthesia
- American Society of Anesthesiologists (ASA) physical status I or II
Who cannot join
- History of taking medications that may affect the central nervous system or autonomic nervous system (e.g., anticholinergics, beta-blockers, antidepressants, anxiolytics, hypnotics, or analgesics)
- Known hypersensitivity to sevoflurane, desflurane, or other halogenated anesthetics, or a personal or family history of malignant hyperthermia
- Neurologic or psychiatric disorders (e.g., depression, dementia, or cerebral infarction)
- Arrhythmia
- Diabetes mellitus
- Drug abuse or alcohol abuse
Show all 9Show fewer
- Vulnerable subjects
- Patients aged 80 years or older
- Patients with impaired consciousness or those judged to lack the capacity to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
About this study
This prospective randomized controlled study will compare the effects of sevoflurane and desflurane on the Analgesia Nociception Index (ANI) in adult patients undergoing general anesthesia. Participants will be randomized to maintenance anesthesia with either sevoflurane or desflurane, and ANI responses to a standardized nociceptive stimulus will be measured under equi-minimum alveolar concentration (age-adjusted 1.0 MAC) conditions. The primary objective is to compare the change in ANI before and after tetanic stimulation between the two anesthetic groups. Secondary measurements will include bispectral index, blood pressure, heart rate, and end-tidal anesthetic concentration around the time of stimulation.
Read the detailed description
This prospective randomized controlled study will compare the effects of sevoflurane and desflurane on the Analgesia Nociception Index (ANI) in adult patients undergoing general anesthesia. Conventional indicators of intraoperative nociception, such as changes in blood pressure, heart rate, and patient movement, can be influenced by anesthetic depth, vasoactive agents, and intravascular volume status. ANI is a heart rate variability-based monitoring index developed to provide a more objective assessment of nociception during general anesthesia. Previous studies have suggested that sevoflurane and desflurane may produce different nociceptive responses at equi-minimum alveolar concentration (MAC), but comparative data using ANI are lacking. In this study, eligible patients will be randomized to maintenance anesthesia with either sevoflurane or desflurane. After standardized induction and stabilization at age-adjusted 1.0 MAC, a standardized tetanic stimulation will be applied, and ANI will be recorded 1 minute before and 1 minute after stimulation. The primary objective is to compare the between-group difference in ANI change in response to the same nociceptive stimulus under equi-MAC conditions. Secondary assessments will include bispectral index, blood pressure, and heart rate measured around the time of stimulation.
- Conditions
- General Anesthesia
- Being tested
- Desflurane, Sevoflurane
- Keywords
- Analgesia Nociception Index, ANI, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Desflurane will be administered for maintenance of general anesthesia after loss of consciousness following propofol induction. End-tidal desflurane concentration will be titrated to age-adjusted 1.0 MAC (±0.1 MAC) at the time of ANI assessment.
SevofluraneDrug
Sevoflurane will be administered for maintenance of general anesthesia after loss of consciousness following propofol induction. End-tidal sevoflurane concentration will be titrated to age-adjusted 1.0 MAC (±0.1 MAC) at the time of ANI assessment.
| Study group | Role | What they receive |
|---|---|---|
| Desflurane | Experimental | Participants randomized to this arm will receive desflurane for maintenance of general anesthesia after standardized induction with lidocaine, propofol target-controlled infusion, and rocuronium. End-tidal desflurane concentration will be adjusted to maintain age-adjusted 1.0 minimum alveolar concentration (MAC) before standardized tetanic stimulation. ANI, BIS, blood pressure, and heart rate will be recorded before and after stimulation. Receives: Drug: Desflurane |
| Sevoflurane | Active comparator | Participants randomized to this arm will receive sevoflurane for maintenance of general anesthesia after standardized induction with lidocaine, propofol target-controlled infusion, and rocuronium. End-tidal sevoflurane concentration will be adjusted to maintain age-adjusted 1.0 minimum alveolar concentration (MAC) before standardized tetanic stimulation. ANI, BIS, blood pressure, and heart rate will be recorded before and after stimulation. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Analgesia Nociception Index (ANI) From 1 Minute Before to 1 Minute After Tetanic Stimulation
ANI will be measured 1 minute before and 1 minute after standardized tetanic stimulation. The primary analysis will compare the between-group difference in ANI change from before to after stimulation.
Measured: From 1 minute before tetanic stimulation to 1 minute after tetanic stimulation
Secondary outcomes (3)
Bispectral Index (BIS)
Measured: Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation
Blood Pressure
Measured: Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation
Heart Rate
Measured: Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, parallel-group study in which participants are assigned in a 1:1 ratio to desflurane or sevoflurane maintenance anesthesia. Under age-adjusted 1.0 MAC conditions, ANI responses to standardized tetanic stimulation will be compared between groups.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511634
- Sponsor's protocol ID
- SevDesANI
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 Apr 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sevoflurane and Desflurane on ANI in Patients Undergoing General Anesthesia: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07511634
- Acronym / sponsor ID
- SevDesANI
- Conditions
- General Anesthesia
- Keywords
- Analgesia Nociception Index, ANI, Sevoflurane
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Apr 2026 (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 prospective randomized controlled study will compare the effects of sevoflurane and desflurane on the Analgesia Nociception Index (ANI) in adult patients undergoing general anesthesia. Participants will be randomized to maintenance anesthesia with either sevoflurane or desflurane, and ANI responses to a standardized nociceptive stimulus will be measured under equi-minimum alveolar concentration (age-adjusted 1.0 MAC) conditions. The primary objective is to compare the change in ANI before and after tetanic stimulation between the two anesthetic groups. Secondary measurements will include bispectral index, blood pressure, heart rate, and end-tidal anesthetic concentration around the time of stimulation.
Detailed description
This prospective randomized controlled study will compare the effects of sevoflurane and desflurane on the Analgesia Nociception Index (ANI) in adult patients undergoing general anesthesia. Conventional indicators of intraoperative nociception, such as changes in blood pressure, heart rate, and patient movement, can be influenced by anesthetic depth, vasoactive agents, and intravascular volume status. ANI is a heart rate variability-based monitoring index developed to provide a more objective assessment of nociception during general anesthesia. Previous studies have suggested that sevoflurane and desflurane may produce different nociceptive responses at equi-minimum alveolar concentration (MAC), but comparative data using ANI are lacking. In this study, eligible patients will be randomized to maintenance anesthesia with either sevoflurane or desflurane. After standardized induction and stabilization at age-adjusted 1.0 MAC, a standardized tetanic stimulation will be applied, and ANI will be recorded 1 minute before and 1 minute after stimulation. The primary objective is to compare the between-group difference in ANI change in response to the same nociceptive stimulus under equi-MAC conditions. Secondary assessments will include bispectral index, blood pressure, and heart rate measured around the time of stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, parallel-group study in which participants are assigned in a 1:1 ratio to desflurane or sevoflurane maintenance anesthesia. Under age-adjusted 1.0 MAC conditions, ANI responses to standardized tetanic stimulation will be compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Desflurane | Experimental | Drug: DesfluraneParticipants randomized to this arm will receive desflurane for maintenance of general anesthesia after standardized induction with lidocaine, propofol target-controlled infusion, and rocuronium. End-tidal desflurane concentration will be adjusted to maintain age-adjusted 1.0 minimum alveolar concentration (MAC) before standardized tetanic stimulation. ANI, BIS, blood pressure, and heart rate will be recorded before and after stimulation. |
| Sevoflurane | Active comparator | Drug: SevofluraneParticipants randomized to this arm will receive sevoflurane for maintenance of general anesthesia after standardized induction with lidocaine, propofol target-controlled infusion, and rocuronium. End-tidal sevoflurane concentration will be adjusted to maintain age-adjusted 1.0 minimum alveolar concentration (MAC) before standardized tetanic stimulation. ANI, BIS, blood pressure, and heart rate will be recorded before and after stimulation. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 19 to 79 years
- Patients undergoing general anesthesia
- American Society of Anesthesiologists (ASA) physical status I or II
Key exclusion criteria (9 listed)
- History of taking medications that may affect the central nervous system or autonomic nervous system (e.g., anticholinergics, beta-blockers, antidepressants, anxiolytics, hypnotics, or analgesics)
- Known hypersensitivity to sevoflurane, desflurane, or other halogenated anesthetics, or a personal or family history of malignant hyperthermia
- Neurologic or psychiatric disorders (e.g., depression, dementia, or cerebral infarction)
- Arrhythmia
- Diabetes mellitus
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 |
|---|---|---|
| DesfluraneDesflurane will be administered for maintenance of general anesthesia after loss of consciousness following propofol induction. End-tidal desflurane concentration will be titrated to age-adjusted 1.0 MAC (±0.1 MAC) at the time of ANI assessment. | Drug | Desflurane |
| SevofluraneSevoflurane will be administered for maintenance of general anesthesia after loss of consciousness following propofol induction. End-tidal sevoflurane concentration will be titrated to age-adjusted 1.0 MAC (±0.1 MAC) at the time of ANI assessment. | Drug | Sevoflurane |
Primary outcome
Change in Analgesia Nociception Index (ANI) From 1 Minute Before to 1 Minute After Tetanic Stimulation
Time frame: From 1 minute before tetanic stimulation to 1 minute after tetanic stimulation
ANI will be measured 1 minute before and 1 minute after standardized tetanic stimulation. The primary analysis will compare the between-group difference in ANI change from before to after stimulation.
3 secondary outcomes
Bispectral Index (BIS)
Time frame: Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation
Blood Pressure
Time frame: Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation
Heart Rate
Time frame: Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 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.
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 Desflurane and Sevoflurane in people with General Anesthesia, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 6 Apr 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
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 Analgesia Nociception Index (ANI) From 1 Minute Before to 1 Minute After Tetanic Stimulation (time frame: From 1 minute before tetanic stimulation to 1 minute after tetanic stimulation). 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 Apr 2026.