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Clinical Trials/NCT05049577
NCT05049577
Completed
Not Applicable

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

Wonkwang University Hospital1 site in 1 country124 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Acute
Sponsor
Wonkwang University Hospital
Enrollment
124
Locations
1
Primary Endpoint
The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cheol Lee,MD,PhD,

Professor

Wonkwang University Hospital

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.

Outcomes

Primary Outcomes

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

  • Incidence and severity of PIP(during anesthesia induction ( half-dose (1mg/kg) and full-dose of (2mg/kg) propofol administration))
  • The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)(Immediately before administration of propofol (2mg/kg))

Study Sites (1)

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