ANI-guided Intraoperative Analgesia in Low-pressure Anesthesia

Analgesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04319913
• Other study ID #: 20MMHIS069e
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Mackay Memorial Hospital
• Contact: Chien-Chung Huang, MD
• Phone: +886225433535
• Email: cchuang[@]dr.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Functional Endoscopic Sinus Surgery
• Heart Rate Variability
• Opioid Consumption

Intervention

Device:
• analgesia nociception index
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.

Locations

Country	Name	City	State
Taiwan	MacKay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood loss	Blood loss would be estimated by surgeon	the estimated blood loss would be recorded immediately after the operation
Other	Bleeding of the operation field	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.	The questionnaire would be provided to the surgeon immediately after the operation
Primary	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	Anesthetics consumption	The amount of anesthetics (mainly propofol) used intraoperatively would be recorded	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.