Comparison of Sevoflurane and Propofol on ANI

Not Applicable

Not yet recruiting

• Conditions: Propofol; Sevoflurane; Analgesia Nociception Index
• Interventions: Drug: Sevoflurane; Drug: propofol

• Registration Number: NCT06907823
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-28
• Study Start: 2025-03-31
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane	Sevoflurane	-
Propofol	propofol	-

Primary Outcome Measures

Name	Time	Method
analgesia nociception index change	During anesthesia period	analgesia nociception index value 1-minute before tetanic stimulation and 1-minute after tetanic stimulation

Secondary Outcome Measures

Name	Time	Method
Hemodynamic change	During anesthesia period	Heart rate change before 1-minute before nociceptive stimuli and 1-minute after nociceptive stimuli