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ANI-guided Intraoperative Analgesia in Low-pressure Anesthesia

NCT04319913 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-03-15

No results posted yet for this study

Summary

During functional endoscopic sinus surgery(FESS), low-pressure anesthesia is often applied, aiming to decreased operative blood loss, and anesthetics, narcotics and antihypertensive agents are given to achieve desirable low blood pressure. However, the dose of these medications given is usually decided subjectively based on the clinical experience of the care provider, placing the patient in a risky situation of narcotics overdosing or underdosing. Therefore, here is the question: Whether intraoperative analgesia guided by an objective pain monitoring device, such as the Analgesia Nociception Index (ANI), could decrease the amount of narcotics, other anesthetic agents, and blood loss in patients undergoing low-pressure anesthesia.

Conditions

  • Analgesia
  • Functional Endoscopic Sinus Surgery
  • Heart Rate Variability
  • Opioid Consumption

Interventions

DEVICE

analgesia nociception index

Analgesia nociception index (ANI) could objectively monitor how pain the participant is. In the experimental group, the care provider would decrease the dose of narcotics (remifentanil) if the ANI value is above 70, and increase the dose if the ANI value is under 50.

Sponsors & Collaborators

  • Mackay Memorial Hospital

    lead OTHER

Principal Investigators

  • Chien-Chung Huang, MD · Mackay Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2023-12-30
Completion
2023-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04319913 on ClinicalTrials.gov