ANI-guided Intraoperative Analgesia in Low-pressure Anesthesia

NCT04319913 | Unknown

• 1 other identifier: 20MMHIS069e
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

analgesia nociception index; functional endoscopic sinus surgery; analgesia; opioid consumption; heart rate variability; low pressure anesthesia

Outcome Measures

Primary Outcomes (1)

• Narcotics consumption

  Remifentanil would be used as narcotics, the total amount used intraoperatively would be recorded

  From the first given dose of remifentanil until the last given given dose of remifentanil during anesthesia, assessed up to 8 hours.

Secondary Outcomes (1)

• Anesthetics consumption

  From the first given dose of anesthetics (propofol or midazolam, whichever comes first) until the last given given dose of anesthetics (propofol or midazolam, whichever comes last), assessed up to 8 hours.

Other Outcomes (2)

• Blood loss

  the estimated blood loss would be recorded immediately after the operation

• Bleeding of the operation field

  The questionnaire would be provided to the surgeon immediately after the operation

Study Arms (2)

ANI-guided

EXPERIMENTAL

ANI-guided narcotics use to maintain ANI value between 50 to 70

Device: analgesia nociception index

Control

NO INTERVENTION

narcotics use guided by clinical experience, ANI is still recorded but would be covered up intraoperatively

Interventions

analgesia nociception index DEVICE

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.

ANI-guided

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status class I or II
• age between 20-65
• body mass index less than 35
• scheduled for functional endoscopic sinus surgery

You may not qualify if:

• major cardiovascular disease, arrhythmia, respiratory disease, cerebral vascular disease, or ASA physical status classification III or greater
• documented or self-reported history of chronic pain
• acute or chronic opioid analgesic use
• dysautonomia
• diabetes mellitus with evidence of neuropathy
• emergency cases
• allergy to medications in the study

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

MacKay Memorial Hospital

Taipei, 104, Taiwan

RECRUITING

Related Publications (3)

• Boselli E, Bouvet L, Begou G, Dabouz R, Davidson J, Deloste JY, Rahali N, Zadam A, Allaouchiche B. Prediction of immediate postoperative pain using the analgesia/nociception index: a prospective observational study. Br J Anaesth. 2014 Apr;112(4):715-21. doi: 10.1093/bja/aet407. Epub 2013 Dec 8.

  PMID: 24322571 BACKGROUND

• Julien-Marsollier F, Rachdi K, Caballero MJ, Ayanmanesh F, Vacher T, Horlin AL, Skhiri A, Brasher C, Michelet D, Dahmani S. Evaluation of the analgesia nociception index for monitoring intraoperative analgesia in children. Br J Anaesth. 2018 Aug;121(2):462-468. doi: 10.1016/j.bja.2018.03.034. Epub 2018 Jun 5.

  PMID: 30032886 BACKGROUND

• Le Gall L, David A, Carles P, Leuillet S, Chastel B, Fleureau C, Dewitte A, Ouattara A. Benefits of intraoperative analgesia guided by the Analgesia Nociception Index (ANI) in bariatric surgery: An unmatched case-control study. Anaesth Crit Care Pain Med. 2019 Feb;38(1):35-39. doi: 10.1016/j.accpm.2017.09.004. Epub 2017 Oct 12.

  PMID: 29033356 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chien-Chung Huang, MD

  Mackay Memorial Hospital

  STUDY DIRECTOR

Central Study Contacts

Chien-Chung Huang, MD

CONTACT

+886225433535; cchuang@dr.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The analgesia nociception index sensors are a pair of patches. They would be placed on the participant's right shoulder and the left side of the chest before the induction of general anesthesia, recording the ANI value throughout the operation. In the control group, the ANI monitor would be covered up, so that the care provider could only titrate remifentanil based on clinical experience. The participants would be masked from which group they were allocated into. The surgeon would be masked from the participant's allocation, and surgeon's satisfaction to the operation field would be surveyed by a questionnaire right after the operation, also the estimated blood loss amount would be recorded by the same surgeon.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician of anesthesiology , Principal Investigator

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: July 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)