Comparison of Sevoflurane and Propofol on ANI

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sevoflurane; Propofol; Analgesia Nociception Index
• Intervention / Treatment: Drug: Sevoflurane; Drug: propofol

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sevoflurane	Drug: Sevoflurane; sevoflurane anesthesia
Other: Propofol	Drug: propofol; propofol anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesia nociception index change	analgesia nociception index value 1-minute before tetanic stimulation and 1-minute after tetanic stimulation	During anesthesia period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic change	Blood pressure change 1 minute before tetanic stimuation and 1 minute after tetanic stimulation	During anesthesia period
Hemodynamic change	Heart rate change before 1-minute before nociceptive stimuli and 1-minute after nociceptive stimuli	During anesthesia period

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 8, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Anesthetics, Inhalation; Sevoflurane; Propofol
• Other Study ID Numbers: 11-2025-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No