Intraoperative Fentanyl Consumption Guided by Analgesia Nociception Index

Khon Kaen University

Status: Completed

Conditions: Postoperative Complications; Postoperative Pain

Treatments: Procedure: ANI protocol; Procedure: Standard protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT03716453

HE611339

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Intraoperative fentanyl administration will be guided by standard protocol

Treatment:

Procedure: Standard protocol

ANI group

Experimental group

Description:

Intraoperative fentanyl administration will be guided by ANI protocol

Treatment:

Procedure: ANI protocol