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

Sponsor
Wonkwang University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05049577
Collaborator
(none)
124
Enrollment
1
Location
2
Arms
5
Actual Duration (Months)
25
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Analgesia/Nociception Index (ANI)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective randomized and controlled studyProspective randomized and controlled study
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
All study drugs were administered using a Minto pharmacokinetic model in a TCI device (Orchestra, Fresenius-Vial, France). The infusion pump was covered to blind the patients, investigator, and outcomes assessor
Primary Purpose:
Screening
Official Title:
Can Preanesthetic Analgesia/Nociception Index (ANI) Predict Propofol Injection Pain
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
Apr 30, 2021
Actual Study Completion Date :
Jul 30, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 60 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 WonwangUH Iksan Jeonbuk Korea, Republic of 570-711

    Sponsors and Collaborators

    • Wonkwang University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Cheol Lee,MD,PhD,, Professor, Wonkwang University Hospital
    ClinicalTrials.gov Identifier:
    NCT05049577
    Other Study ID Numbers:
    • WonkwangUH8
    First Posted:
    Sep 20, 2021
    Last Update Posted:
    Sep 20, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Acute Pain
    Nociceptive Pain

    Study Results

    No Results Posted as of Sep 20, 2021