NCT07511634|Not Yet Recruiting
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Sponsor study identifier
interventional
80
1 country
1
Study Start
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 30, 2026
Actual (reported)April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 6, 2026
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
From 1 minute before tetanic stimulation to 1 minute after tetanic stimulation
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
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.
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.
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.
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.
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612, South Korea
First Submitted
March 30, 2026
First Posted
April 6, 2026
Study Start
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Vasodilation Effect of Inhalational Anesthetics
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Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 6, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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