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

March 30, 2026 updated by: Pusan National University Yangsan Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, South Korea, 50612
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Desflurane
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.
Drug: Desflurane
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.
Active Comparator: Sevoflurane
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.
Drug: Sevoflurane
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From 1 minute before tetanic stimulation to 1 minute after tetanic stimulation

Secondary Outcome Measures

Outcome Measure
Time Frame
Bispectral Index (BIS)
Time Frame: Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation
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
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
Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Yangsan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SevDesANI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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