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

October 6, 2023 updated by: Cheol Lee,MD,PhD,, Wonkwang University Hospital

Can Preanesthetic Analgesia/Nociception Index (ANI) Predict 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
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.
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.
Other Names:
  • ANI MOC-9
Experimental: Remifentanil group
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
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.
Other Names:
  • ANI MOC-9

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately before administration of propofol (2mg/kg)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: Immediately before administration of propofol (2mg/kg)
The correlation of preanesthetic ANI scores and severity of PIP.
Immediately before administration of propofol (2mg/kg)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wonkwang University Hospital

Investigators

  • Principal Investigator: Cheol Lee, M.D,Ph.D, Department of anesthesiology and pain medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

April 10, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

September 17, 2021

First Posted (Actual)

September 20, 2021

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WonkwangUH8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

if other researchers ask, a decision will be made after discussion with the co-authors

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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