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

ConditionGeneral Anesthesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-79
SponsorPusan National University Yangsan Hospital

About this trial

This prospective randomized controlled study will compare the effects of sevoflurane and desflurane on the Analgesia Nociception Index (ANI) in adult patients undergoing general anesthesia. Participants will be randomized to maintenance anesthesia with either sevoflurane or desflurane, and ANI responses to a standardized nociceptive stimulus will be measured under equi-minimum alveolar concentration (age-adjusted 1.0 MAC) conditions. The primary objective is to compare the change in ANI before and after tetanic stimulation between the two anesthetic groups. Secondary measurements will include bispectral index, blood pressure, heart rate, and end-tidal anesthetic concentration around the time of stimulation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 19 to 79 years

Patients undergoing general anesthesia

American Society of Anesthesiologists (ASA) physical status I or II

Disqualifiers

History of taking medications that may affect the central nervous system or autonomic nervous system (e.g., anticholinergics, beta-blockers, antidepressants, anxiolytics, hypnotics, or analgesics)

Known hypersensitivity to sevoflurane, desflurane, or other halogenated anesthetics, or a personal or family history of malignant hyperthermia

Neurologic or psychiatric disorders (e.g., depression, dementia, or cerebral infarction)

Arrhythmia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Desflurane

    Drug

    Desflurane will be administered for maintenance of general anesthesia after loss of consciousness following propofol induction. End-tidal desflurane concentration will be titrated to age-adjusted 1.0 MAC (±0.1 MAC) at the time of ANI assessment.

  • Sevoflurane

    Drug

    Sevoflurane will be administered for maintenance of general anesthesia after loss of consciousness following propofol induction. End-tidal sevoflurane concentration will be titrated to age-adjusted 1.0 MAC (±0.1 MAC) at the time of ANI assessment.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: DesfluraneExperimental treatment 1 intervention
Group B: SevofluraneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Analgesia Nociception Index (ANI) From 1 Minute Before to 1 Minute After Tetanic Stimulation

ANI will be measured 1 minute before and 1 minute after standardized tetanic stimulation. The primary analysis will compare the between-group difference in ANI change from before to after stimulation.

Time frame
From 1 minute before tetanic stimulation to 1 minute after tetanic stimulation

Secondary outcomes

1

Bispectral Index (BIS)

Time frame
Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation
2

Blood Pressure

Time frame
Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation
3

Heart Rate

Time frame
Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pusan National University Yangsan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: