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

NCT05049577 | Completed DMC

• 1 other identifier: WonkwangUH8
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Analgesia; Nociceptive Pain

Outcome Measures

Primary Outcomes (1)

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

  The correlation of preanesthetic ANI scores and incidence of PIP.

  Immediately before administration of propofol (2mg/kg)

Secondary Outcomes (2)

• 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 Arms (2)

Control group

PLACEBO COMPARATOR

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)

Remifentanil group

EXPERIMENTAL

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)

Interventions

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.

Also known as: ANI MOC-9

Control group; Remifentanil group

Eligibility Criteria

• Age: 19 Years - 60 Years
• Gender Eligibility Details: Male patients aged 19-60 years and the american society of anesthesiologists(ASA) class I or II who were scheduled for general anesthesia
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male patients who scheduled for general anesthesia
• Cognitive patients who could understand this study

You may not qualify if:

• Patients receiving β-receptor blockers, ketamine, clonidine, or any vasoactive substance (i.e. metaraminol, ephedrine) and patients receiving neostigmine, atropine or glycopyrrolate.

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

WonwangUH

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

Location

Related Publications (3)

• 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.

  PMID: 29121287 BACKGROUND

• 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.

  PMID: 31047645 BACKGROUND

• 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.

  PMID: 31192070 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Agnosia; Nociceptive Pain

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Cheol Lee, M.D,Ph.D

  Department of anesthesiology and pain medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective randomized and controlled study

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 20, 2021
• Study Start: April 1, 2023
• Primary Completion: April 10, 2023
• Study Completion: June 30, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)