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

Primary Purpose

Pain, Acute, Analgesia, Nociceptive Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Analgesia/Nociception Index (ANI)
Sponsored by
Wonkwang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Pain, Acute

Eligibility Criteria

19 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • WonwangUH

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Remifentanil group

Arm Description

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 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence and severity of PIP
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)
The correlation of preanesthetic ANI scores and severity of PIP.

Full Information

First Posted
August 24, 2021
Last Updated
October 6, 2023
Sponsor
Wonkwang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05049577
Brief Title
Preanesthetic Analgesia/Nociception Index (ANI) and Propofol Injection Pain
Official Title
Can Preanesthetic Analgesia/Nociception Index (ANI) Predict Propofol Injection Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
April 10, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wonkwang University Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Analgesia, Nociceptive Pain

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized and controlled study
Masking
ParticipantInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Remifentanil group
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Analgesia/Nociception Index (ANI)
Other Intervention Name(s)
ANI MOC-9
Intervention Description
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.
Primary Outcome Measure Information:
Title
The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)
Description
The correlation of preanesthetic ANI scores and incidence of PIP.
Time Frame
Immediately before administration of propofol (2mg/kg)
Secondary Outcome Measure Information:
Title
Incidence and severity of PIP
Description
Incidence and severity with numeric rating scales( 0= no pain, 100=worst pain) of propofol injection pain
Time Frame
during anesthesia induction ( half-dose (1mg/kg) and full-dose of (2mg/kg) propofol administration)
Title
The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)
Description
The correlation of preanesthetic ANI scores and severity of PIP.
Time Frame
Immediately before administration of propofol (2mg/kg)

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male patients aged 19-60 years and the american society of anesthesiologists(ASA) class I or II who were scheduled for general anesthesia
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheol Lee, M.D,Ph.D
Organizational Affiliation
Department of anesthesiology and pain medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
WonwangUH
City
Iksan
State/Province
Jeonbuk
ZIP/Postal Code
570-711
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
if other researchers ask, a decision will be made after discussion with the co-authors
Citations:
PubMed Identifier
29121287
Citation
Chanques G, Tarri T, Ride A, Prades A, De Jong A, Carr J, Molinari N, Jaber S. Analgesia nociception index for the assessment of pain in critically ill patients: a diagnostic accuracy study. Br J Anaesth. 2017 Oct 1;119(4):812-820. doi: 10.1093/bja/aex210.
Results Reference
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PubMed Identifier
31047645
Citation
Ledowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30.
Results Reference
background
PubMed Identifier
31192070
Citation
Abdullayev R, Yildirim E, Celik B, Topcu Sarica L. Analgesia Nociception Index: Heart Rate Variability Analysis of Emotional Status. Cureus. 2019 Apr 2;11(4):e4365. doi: 10.7759/cureus.4365.
Results Reference
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Preanesthetic Analgesia/Nociception Index (ANI) and Propofol Injection Pain

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