Skip to content

Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane

Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05063461
Enrollment
32
Registered
2021-10-01
Start date
2021-09-25
Completion date
2023-03-01
Last updated
2023-03-22

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

Conditions

General Anesthesia

Brief summary

Analgesia Nociception Index(ANI)which is derived from heart rate variability can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. The aim of this study is to verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination during sevoflurane while changing remifentanil concentrations.

Detailed description

General anesthesia with sevoflurane and remifentanil is widely used in minor surgeries. Monitoring noxious stimulation during general anesthesia is still worth further studies and reaching clinical consensus. Analgesia Nociception Index can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. Previous studies suggest that an ANI≥50 can be useful in detecting sufficient analgesia for patients who cannot self-report pain. The aim of this study is to verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination during sevoflurane while changing remifentanil concentrations.

Interventions

For each participant, record the first concentration that ANI≥50 after the tetanic stimuli, as the sufficient concentration.

PROCEDURESkin incision

Infuse the sufficient concentration for at least 5min of the steady-state period, then surgical stimulus is applied. The surgical stimulus is defined as the first skin incision to establish pneumoperitoneum.

Sponsors

Beijing Chao Yang Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Age between 18- 65 years * ASA physical status I or II * Elective surgery in general anesthesia planned * Written informed consent

Exclusion criteria

* Use of CNS-active medication or abuse of alcohol * Presents of any neuromuscular or neurologic disease * History of cardiac arrhythmia * Pregnancy or using a pacemaker

Design outcomes

Primary

MeasureTime frameDescription
To verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination.Change from Baseline ANI that 2 minutes after applied tetanic stilumationTetanic stimulations are applied at different effect site concentrations of remifentanil under sevoflurane anesthesia. ANI is range from 0-100. Bigger number means better analgesic level. ANI≥50 is considered to be under adequate analgesia. Tetanic stimulation is a standard tester of nociceptive stimulus. The number of ANI will fall down if the patient is feeling pain.

Secondary

MeasureTime frameDescription
The ANI predictability for tetanic noxious stimuliChange from Baseline Systolic Blood Pressure that 2 minutes after applied tetanic stilumationANI is range from 0-100. Bigger number means better analgesic level. ANI≥50 is considered to be under adequate analgesia. The number of ANI will fall down if the patient is feeling pain.
The heart rate predictability for tetanic noxious stimuliChange from Baseline Heart Rate that 2 minutes after applied tetanic stilumationHeart Rate will go up if patient is feeling pain.
The Bispectral Index predictability for tetanic noxious stimuliChange from Baseline Bispectral Index that 2 minutes after applied tetanic stilumationBispectral Index will go up if patient is feeling pain.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026