Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05063461
Other study ID # 00375930
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04577430 - Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period N/A
Completed NCT03708692 - Menstrual Cycle Phases on Recovery and Cognitive Function
Recruiting NCT03422315 - Population Pharmacokinetics and Clinical Individual Dosage Regimen of Propofoll Injection N/A
Completed NCT02771067 - The Utility of Pulse Pressure Variation to Predict the Fluid Responsiveness During Pneumoperitoneum and Reverse-Trendelenburg Position N/A
Completed NCT03294226 - Comparison of AuraGain With I-gel for Pediatric Patients N/A
Not yet recruiting NCT03643029 - The Accuracy of the Performance and Placement Test for Predicting Supraglottic Airway Device (SAD) Position in the Hypopharynx as Confirmed With Video Laryngoscopy N/A
Completed NCT01945411 - Assessment of Facial Measurements, the Length of Mouth Corner-mandible Angle and Incisors-mandible Angle, for Determining the Proper Sizes of Oropharyngeal Airway N/A
Not yet recruiting NCT01678066 - A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor N/A
Completed NCT01705743 - Minimum Alveolar Concentration of Sevoflurane With Nitrous Oxide Inducing Isoelectric EEG Phase 4
Completed NCT00972491 - The Optimal Time to Put Laryngeal Mask Airway in the Mouth Under General Anesthesia N/A
Completed NCT00741507 - Unhealthy Alcohol Drinking and Anesthetic Requirement in Women N/A
Completed NCT01096212 - Efficacy and Safety of Sevofran in Patients Scheduled for Elective Surgery Under General Anesthesia Phase 4
Completed NCT00532402 - Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas N/A
Completed NCT00599066 - Intraoperative M-Entropy Measurements N/A
Completed NCT00468494 - Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia? N/A
Recruiting NCT00492453 - Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy N/A
Recruiting NCT03745079 - Correlation Between Core Temperature and Skin Temperature Measured by 3M SpotOn
Completed NCT04094376 - Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia N/A
Enrolling by invitation NCT03672734 - Volume and pH of Gastric Contents in Patients Undergoing Gynecologic Laparoscopic Surgery During Emergence From General Anesthesia
Recruiting NCT04926220 - Dynamic Estimation of Cardiac Output in the Operating Room