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

Not Applicable

Completed

• Conditions: Pain, Acute; Nociceptive Pain; Analgesia
• Interventions: Device: Analgesia/Nociception Index (ANI)

• Registration Number: NCT05049577
• Lead Sponsor: Wonkwang University Hospital

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.

Study Timeline

• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-20
• Study Start: 2023-04-01
• Primary Completion: 2023-04-10
• Study Completion: 2023-06-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Analgesia/Nociception Index (ANI)	To maintain blinding, in the control group, the remifentanil infusion was replaced with 50 ml of normal saline in 50 ml syringe. The remifentanil (or saline) infusion was run until the pump indicated the target Ce had been achieved. Pharmacokinetic model for remifentanil was the Minto model (Height, Weight, and Age) Anesthesia in all patients was induced using 2 mg/kg of 2% propofol. The attending anesthesiologist asked the patients how they felt pain to evaluate pain severity of PIP while half -dose of propofol was administered. After the rest of the propofol was administered, the attending anesthesiologists asked the same question.
Remifentanil group	Analgesia/Nociception Index (ANI)	Remifentanil 1 mg was diluted into 50 ml of normal saline. A commercial TCI pump (Orchestra Base Primea, Fresenius Vial, France) was used for the effect-site TCI of remifentanil. The study groups received remifentanil to a target Ce of 4 ng/ ml. Pharmacokinetic model for remifentanil was the Minto model (Height, Weight, and Age) Anesthesia induction and the evaluation of pain were same as control group

Primary Outcome Measures

Name	Time	Method
The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)	Immediately before administration of propofol (2mg/kg)	The correlation of preanesthetic ANI scores and incidence of PIP.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

WonwangUH; 🇰🇷 Iksan, Jeonbuk, Korea, Republic of