Intraoperative Fentanyl Consumption Guided by Analgesia Nociception Index

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Preanesthetic Analgesia/Nociception Index (ANI) and Propofol Injection Pain

NCT05049577

Pain, Acute Analgesia Nociceptive Pain

COMPLETED NA

Evaluation of Analgesia Nociception Index (ANI) During Propofol/Remifentanil and Sevoflurane/Remifentanil Anesthesia

NCT01522508

General Anaesthesia

UNKNOWN

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

NCT05063461

General Anesthesia

COMPLETED NA

Opioid-based Versus Opioid-free Endotracheal Intubation

NCT06464393

Anesthesia Anesthesia Intubation Opioid Use +2 more

COMPLETED NA

Automatic Remifentanil Administration Guided by ANI During Propofol Anesthesia

NCT03556696

Nociceptive Pain Surgical Procedure, Unspecified

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Objective: To evaluate the efficacy of ANI to guide the administration of intraoperative fentanyl.

Methods: Sixty female patients undergoing breast surgery with balanced anesthesia will be randomized into 2 groups. The first group will receive fentanyl according to standard practice of attending anesthesiologists. The second group will receive fentanyl according to ANI score protocol.

Primary outcome: Postoperative pain numeric rating scale (NRS) score during 60 minutes in postanesthetic care unit (PACU).

Secondary outcomes: Total intraoperative dose of fentanyl and postoperative nausea/vomiting and sedation score in PACU.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain Postoperative Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Intraoperative fentanyl administration will be guided by standard protocol

Group Type PLACEBO_COMPARATOR

Standard protocol

Intervention Type PROCEDURE

Give narcotic according to vital signs

ANI group

Intraoperative fentanyl administration will be guided by ANI protocol

Group Type EXPERIMENTAL

ANI protocol

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard protocol

Give narcotic according to vital signs

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults female undergoing elective breast surgery
* American Society of Anesthesiologists (ASA) classification I-III
* Body mass index (BMI) 18.5-35 kg/m2

Exclusion Criteria

* Implanted pacemaker
* Cardiac arrythmia
* Autonomic nervous system (ANS) disorder, e.g. epilepsy, stroke
* Chronic opioid use
* Chronic pain
* On beta-blocker, calcium channel blocker, or other drugs to control arrythmia
* Previous mastectomy
* Pregnancy
* On Nsaids

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No