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NCT Number: NCT06907823

Comparison of Sevoflurane and Propofol on ANI

The goal of this clinical trial is to compare the effect of sevoflurane and propofol on analgesia nociception index(ANI) in patients undergoing general anesthesia. The main question it aims to answer is whether propofol anesthesia results in lesser ANI change to a nociceptive stimulation compared to sevoflurane.

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Key information

Conditions

Propofol Analgesia Nociception Index Sevoflurane

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Patients will be allocated to either propofol or sevoflurane group. Nociceptive event will be defined as long-lasting tetanic stimulation, square-wave, duration of 30 seconds , amplitude of 50mA, frequency of 50 Hz. analgesia nociception index value and hemodynamic parameters will be recorded 1-minute before and after nociceptive event.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American society of anesthesiologists physical status class I or II

Exclusion criteria

  • history of drugs that can affect the central nervous system and autonomic nervous system, such as anticholinergics, betablockers, antidepressants..etc.
  • history of allergic reaction to sevoflurane and/or propofol
  • history of and/or family history of malignant hyperthermia
  • neurodegenerative disorder
  • psychiatric disorder
  • arrhythmia
  • diabetes mellitus
  • drug abuse history

Treatment and study plan

Propofol

Drug

propofol anesthesia

Sevoflurane

Drug

sevoflurane anesthesia

Primary outcomes

  1. analgesia nociception index change

    Time frame: During anesthesia period

    analgesia nociception index value 1-minute before tetanic stimulation and 1-minute after tetanic stimulation

Secondary outcomes

  1. Hemodynamic change

    Time frame: During anesthesia period

    Blood pressure change 1 minute before tetanic stimuation and 1 minute after tetanic stimulation

  2. Hemodynamic change

    Time frame: During anesthesia period

    Heart rate change before 1-minute before nociceptive stimuli and 1-minute after nociceptive stimuli

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 2, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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