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Intraoperative Fentanyl Consumption Guided by Analgesia Nociception Index

NCT03716453 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-11-27

No results posted yet for this study

Summary

Balanced anesthesia needs optimization of hypnotic, relaxant, and narcotic. Administration of hypnotic drugs can be monitored by bispectral index score (BIS), while the dosage of muscle relaxants can be guided by train-of four (TOF). However, administration of narcotics lacks objective monitor. Overdosage of narcotic may lead to delayed awakening, while underdosage may lead to high degree of postoperative pain. Recently, there is a monitor, Analgesic Nociceptive Index (ANI) monitor, designed to guide the administration of narcotics. There are many descriptive studies supporting the correlation of ANI score and pain score but there are still very few randomized control studies which report the efficacy of ANI in clinical practice.

Conditions

  • Postoperative Pain
  • Postoperative Complications

Interventions

PROCEDURE

Standard protocol

Give narcotic according to vital signs

PROCEDURE

ANI protocol

ANI score 50-70 indicates optimal narcotic effect. ANI score \> 70 indicated overdosage of narcotic and narcotic should be withheld. ANI score \< 50 indicates inadequate narcotic and narcotic should be given.

Sponsors & Collaborators

  • Khon Kaen University

    lead OTHER

Principal Investigators

  • Sirirat Tribuddharat, MD, PhD · Faculty of Medicine, Khon Kaen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-05-31
Completion
2019-08-30

Countries

  • Thailand

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 NCT03716453 on ClinicalTrials.gov