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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05063461
• Other study ID #: 00375930
• Status: Completed
• Phase: N/A
• Start date: September 25, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 1, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Device:
• Tetanic stimulation
For each participant, record the first concentration that ANI=50 after the tetanic stimuli, as the sufficient concentration.

Procedure:
• Skin 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.

Locations

Country	Name	City	State
China	Beijing Chao Yang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination.	Tetanic 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.	Change from Baseline ANI that 2 minutes after applied tetanic stilumation
Secondary	The ANI predictability for tetanic noxious stimuli	ANI 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.	Change from Baseline Systolic Blood Pressure that 2 minutes after applied tetanic stilumation
Secondary	The heart rate predictability for tetanic noxious stimuli	Heart Rate will go up if patient is feeling pain.	Change from Baseline Heart Rate that 2 minutes after applied tetanic stilumation
Secondary	The Bispectral Index predictability for tetanic noxious stimuli	Bispectral Index will go up if patient is feeling pain.	Change from Baseline Bispectral Index that 2 minutes after applied tetanic stilumation