ANI-guided Intraoperative Analgesia in Low-pressure Anesthesia
Primary Purpose
Analgesia, Functional Endoscopic Sinus Surgery, Heart Rate Variability
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
analgesia nociception index
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia focused on measuring analgesia nociception index, functional endoscopic sinus surgery, analgesia, opioid consumption, heart rate variability, low pressure anesthesia
Eligibility Criteria
Inclusion Criteria:
- ASA physical status class I or II
- age between 20-65
- body mass index less than 35
- scheduled for functional endoscopic sinus surgery
Exclusion Criteria:
- 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
Sites / Locations
- MacKay Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ANI-guided
Control
Arm Description
ANI-guided narcotics use to maintain ANI value between 50 to 70
narcotics use guided by clinical experience, ANI is still recorded but would be covered up intraoperatively
Outcomes
Primary Outcome Measures
Narcotics consumption
Remifentanil would be used as narcotics, the total amount used intraoperatively would be recorded
Secondary Outcome Measures
Anesthetics consumption
The amount of anesthetics (mainly propofol) used intraoperatively would be recorded
Full Information
NCT ID
NCT04319913
First Posted
March 20, 2020
Last Updated
March 13, 2023
Sponsor
Mackay Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04319913
Brief Title
ANI-guided Intraoperative Analgesia in Low-pressure Anesthesia
Official Title
Whether Intraoperative Analgesia Guided by the Analgesia Nociception Index (ANI) Can Decrease the Amount of Narcotics, Other Anesthetic Drugs, and Blood Loss in Patients Undergoing Low-pressure Anesthesia: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Analgesia nociception index (ANI) is an objective pain monitoring device, it could measure parasympathetic tone base on heart rate variability analysis, which is a way to measure the effect of respiratory sinus arrhythmia on heart rate. In the previous studies, ANI had been used to predict immediate postoperative pain, intraoperative analgesia in children, and intraoperative analgesia in bariatric surgery, which showed ANI can be used to detect surgical stimuli, reduce intraoperative consumption of narcotics, and assess immediate postoperative pain intensity. However, no publication has mentioned ANI been used in low-pressure anesthesia.
Participants with ASA physical status class I or II, age between 20-65, and body mass index less than 35 who would undergo FESS are enrolled and randomly allocated by using computer-generated random number table into two groups with equal probability: ANI-guided remifentanil titration or remifentanil titration by standard care. Total intravenous anesthesia with propofol TCI(target controlled infusion) and remifentanil TCI are used for anesthesia maintenance, targeting bispectral index between 40 and 60. The ANI value in experimental group would be maintained between 50 and 70. Intraoperative mean arterial pressure (MAP) would be targeted at 55-65 mmHg, and calcium channel blocker would be administered if MAP could not achieve target despite of propofol and remifentanil titration.
Participant's demographics, baseline information, type and duration of the operation, duration from end of the surgery till participant awaken, ANI value, vital signs, the amount of narcotics, anesthetics and antihypertensive medications used, intraoperative blood loss, surgeon's satisfaction to the operation field, participant first recorded pain score in postoperative recovery room using visual analogue scale, and opioid-associated side effects such as nausea, vomiting, pruritis, dizziness in postoperative recovery room, will be recorded and analyzed. The statisticians will apply Chi-square for categorical data, T-test for continuous data, and multiple regressions analysis. P value less than 0.05 was considered statistically significant. Using G-power software to estimate, predicted sample size is 120 presuming type I error 0.05, power 0.95, and medium effect size.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ANI-guided
Arm Type
Experimental
Arm Description
ANI-guided narcotics use to maintain ANI value between 50 to 70
Arm Title
Control
Arm Type
No Intervention
Arm Description
narcotics use guided by clinical experience, ANI is still recorded but would be covered up intraoperatively
Intervention Type
Device
Intervention Name(s)
analgesia nociception index
Intervention Description
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.
Primary Outcome Measure Information:
Title
Narcotics consumption
Description
Remifentanil would be used as narcotics, the total amount used intraoperatively would be recorded
Time Frame
From the first given dose of remifentanil until the last given given dose of remifentanil during anesthesia, assessed up to 8 hours.
Secondary Outcome Measure Information:
Title
Anesthetics consumption
Description
The amount of anesthetics (mainly propofol) used intraoperatively would be recorded
Time Frame
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 Pre-specified Outcome Measures:
Title
Blood loss
Description
Blood loss would be estimated by surgeon
Time Frame
the estimated blood loss would be recorded immediately after the operation
Title
Bleeding of the operation field
Description
Bleeding of the operation field would be surveyed to surgeons by a questionnaire.
The clarity of operation field:
Minimal bleeding: no need of suction.
Slightly bleeding: suction sometimes.
Moderate bleeding: Suction frequently
Severe bleeding: surgical field compromised even right after suction
Continuous bleeding.
Time Frame
The questionnaire would be provided to the surgeon immediately after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA physical status class I or II
age between 20-65
body mass index less than 35
scheduled for functional endoscopic sinus surgery
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-Chung Huang, MD
Phone
+886225433535
Ext
3009
Email
cchuang@dr.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Chung Huang, MD
Organizational Affiliation
Mackay Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
MacKay Memorial Hospital
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Chung Huang, MD
Phone
+886225433535
Ext
3009
Email
cchuang@dr.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24322571
Citation
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.
Results Reference
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PubMed Identifier
30032886
Citation
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.
Results Reference
background
PubMed Identifier
29033356
Citation
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.
Results Reference
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ANI-guided Intraoperative Analgesia in Low-pressure Anesthesia
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