NCT05063461

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

September 25, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

1.4 years

First QC Date

September 15, 2021

Last Update Submit

March 19, 2023

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • The ANI predictability for tetanic noxious stimuli

    Change from Baseline Systolic Blood Pressure that 2 minutes after applied tetanic stilumation

  • The heart rate predictability for tetanic noxious stimuli

    Change from Baseline Heart Rate that 2 minutes after applied tetanic stilumation

  • The Bispectral Index predictability for tetanic noxious stimuli

    Change from Baseline Bispectral Index that 2 minutes after applied tetanic stilumation

Study Arms (1)

Sevoflurane with different site effect concentrations of remifentanil

EXPERIMENTAL

The tetanic stimulus is conducted between laryngeal mask intubation and surgical stimulation, while no other noxious stimuli are presented. The effect site concentration of remifentanil is increased step-by-step via a Target Controlled infusion device to a concentration of 2, 4, 6 ng/ml. At least 5min of the steady-state period is maintained before tetanic stimulus.

Device: Tetanic stimulationProcedure: Skin incision

Interventions

Tetanic stimulationDEVICE

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

Sevoflurane with different site effect concentrations of remifentanil
Skin incisionPROCEDURE

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.

Sevoflurane with different site effect concentrations of remifentanil

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, 100020, China

Location

Related Publications (1)

  • Yang L, Wang X, Wen H. Evaluation of the effectiveness of analgesia nociception index (ANI) predictability for surgical stimuli under personal analgesic sufficiency status (PASS) measured by pre-tetanus-induced ANI: a pilot study. J Clin Monit Comput. 2023 Dec;37(6):1585-1591. doi: 10.1007/s10877-023-01044-y. Epub 2023 Jul 7.

    PMID: 37418059DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy chief physician

Study Record Dates

First Submitted

September 15, 2021

First Posted

October 1, 2021

Study Start

September 25, 2021

Primary Completion

February 28, 2023

Study Completion

March 1, 2023

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations

CN(1)