Comparison of Sevoflurane and Propofol on ANI

NCT ID: NCT06907823

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Propofol Sevoflurane Analgesia Nociception Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Sevoflurane

Group Type OTHER

Sevoflurane

Intervention Type DRUG

sevoflurane anesthesia

Propofol

Group Type OTHER

propofol

Intervention Type DRUG

propofol anesthesia

Interventions

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propofol

propofol anesthesia

Intervention Type DRUG

Sevoflurane

sevoflurane anesthesia

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pusan National University Yangsan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jimin Lee

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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11-2025-003

Identifier Type: -

Identifier Source: org_study_id

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