General Anesthesia
Conditions
Keywords
Analgesia Nociception Index, ANI, Sevoflurane
Brief 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. 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.
Interventions
DRUGDesflurane
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.
DRUGSevoflurane
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.
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 19 to 79 years * Patients undergoing general anesthesia * American Society of Anesthesiologists (ASA) physical status I or II
Exclusion criteria
* 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 * Vulnerable subjects * Patients aged 80 years or older * Patients with impaired consciousness or those judged to lack the capacity to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Analgesia Nociception Index (ANI) From 1 Minute Before to 1 Minute After Tetanic Stimulation | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Bispectral Index (BIS) | Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation |
| Blood Pressure | Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation |
| Heart Rate | Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation |
Countries
South Korea
Outcome results
None listed