Preanesthetic Analgesia/Nociception Index (ANI) and Propofol Injection Pain

Analgesia Clinical Trial

Official title:

Can Preanesthetic Analgesia/Nociception Index (ANI) Predict Propofol Injection Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05049577
• Other study ID #: WonkwangUH8
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: Wonkwang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 30, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Nociceptive Pain
• Pain, Acute

Intervention

Device:
• Analgesia/Nociception Index (ANI)
V1 and V5 electrocardiographic positions as per the manufacturer's recommendations. The ANI was continuously recorded and displayed with a frequency of 1 Hz. ANI scores measured immediately before propofol administration, half-dose administration (1mg/kg), and full-dose administration (2mg/kg)of propofol.

Locations

Country	Name	City	State
Korea, Republic of	WonwangUH	Iksan	Jeonbuk

Sponsors (1)

Lead Sponsor	Collaborator
Wonkwang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)	The correlation of preanesthetic ANI scores and incidence of PIP.	Immediately before administration of propofol (2mg/kg)
Secondary	Incidence and severity of PIP	Incidence and severity with numeric rating scales( 0= no pain, 100=worst pain) of propofol injection pain	during anesthesia induction ( half-dose (1mg/kg) and full-dose of (2mg/kg) propofol administration)
Secondary	The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)	The correlation of preanesthetic ANI scores and severity of PIP.	Immediately before administration of propofol (2mg/kg)