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Comparison of Sevoflurane and Propofol on ANI

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06907823
Enrollment
30
Registered
2025-04-02
Start date
2025-06-30
Completion date
2025-12-31
Last updated
2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia Nociception Index, Propofol, Sevoflurane

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.

Interventions

DRUGpropofol

propofol anesthesia

DRUGSevoflurane

sevoflurane anesthesia

Sponsors

Pusan National University Yangsan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
analgesia nociception index changeDuring anesthesia periodanalgesia nociception index value 1-minute before tetanic stimulation and 1-minute after tetanic stimulation

Secondary

MeasureTime frameDescription
Hemodynamic changeDuring anesthesia periodBlood pressure change 1 minute before tetanic stimuation and 1 minute after tetanic stimulation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026