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Completed

NCT Number: NCT05049577

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

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.

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Key information

Conditions

Pain, Acute Acute Pain Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nociceptive Pain Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

19 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

WonwangUH

Iksan, Jeollabuk-do, 570-711, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Analgesia/Nociception Index (ANI)

Device

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.

Other names: ANI MOC-9

Primary outcomes

  1. The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)

    Time frame: Immediately before administration of propofol (2mg/kg)

    The correlation of preanesthetic ANI scores and incidence of PIP.

Secondary outcomes

  1. Incidence and severity of PIP

    Time frame: 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

  2. The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)

    Time frame: Immediately before administration of propofol (2mg/kg)

    The correlation of preanesthetic ANI scores and severity of PIP.

Sponsors and collaborators

Lead sponsor

Wonkwang University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 20, 2021
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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