Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07511634

Comparison of Sevoflurane and Desflurane on ANI in Patients Undergoing General Anesthesia: a Prospective Randomized Controlled Study

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
Pusan National University Yangsan Hospital · Academic / Other
Sex
All
Age
19 Years – 79 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDesfluraneDesflurane 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.
DRUGSevofluraneSevoflurane 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.

Timeline

Start date
2026-04-01
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2026-04-06
Last updated
2026-04-06

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT07511634. Inclusion in this directory is not an endorsement.