Clinical trial NCT05049577: Preanesthetic Analgesia/Nociception Index (ANI) and Propofol Injection Pain
Official title: Can Preanesthetic Analgesia/Nociception Index (ANI) Predict Propofol Injection Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Analgesia
Nociceptive Pain
Lead sponsor: Wonkwang University Hospital
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 124
Sex: MALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized and controlled study
Primary purpose: SCREENING

Brief summary: Recently, Analgesia Nociception Index (ANI) has been evaluated for objectively measuring peri-operative pain and to guide intra-operative opioid administration during various surgeries.

Propofol injection pain (PIP) is a common problem and can be very distressing to the patient.

Detailed description: This study aimed to the association of preanesthetic ANI scores and PIP in patients who scheduled for general anesthesia.

Before propofol administration in remifentanil group, preanesthetic ANI values (instant and mean) were checked after remifentanil to a target Ce of 4 ng/ml.

Control group received the same volume of saline as remifentanil group. Heart rate and bispectral index were checked as ANI. Point biserial correlation and ROC curve were analyzed.

Eligibility criteria: Inclusion Criteria:

* Male patients who scheduled for general anesthesia
* Cognitive patients who could understand this study

Exclusion Criteria:

* Patients receiving β-receptor blockers, ketamine, clonidine, or any vasoactive substance (i.e. metaraminol, ephedrine) and patients receiving neostigmine, atropine or glycopyrrolate.

Primary outcomes:
measure: The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)
timeFrame: Immediately before administration of propofol (2mg/kg)
Secondary outcomes:
measure: Incidence and severity of PIP
timeFrame: during anesthesia induction ( half-dose (1mg/kg) and full-dose of (2mg/kg) propofol administration)
measure: The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)
timeFrame: Immediately before administration of propofol (2mg/kg)
Other outcomes:
Locations:
city: Iksan
country: Korea, Republic of
facility: WonwangUH
state: Jeonbuk
Study officials:
affiliation: Department of anesthesiology and pain medicine
name: Cheol Lee, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chanques G, Tarri T, Ride A, Prades A, De Jong A, Carr J, Molinari N, Jaber S. Analgesia nociception index for the assessment of pain in critically ill patients: a diagnostic accuracy study. Br J Anaesth. 2017 Oct 1;119(4):812-820. doi: 10.1093/bja/aex210.
citation: Ledowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30.
citation: Abdullayev R, Yildirim E, Celik B, Topcu Sarica L. Analgesia Nociception Index: Heart Rate Variability Analysis of Emotional Status. Cureus. 2019 Apr 2;11(4):e4365. doi: 10.7759/cureus.4365.