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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Acute, Analgesia, Nociceptive Pain

Intervention / Treatment
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* Device: Analgesia/Nociception Index (ANI)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized and controlled study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>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)<br>* 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.<br>* Other names: ANI MOC-9;|
| Experimental: Remifentanil group<br>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)<br>* 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.<br>* Other names: ANI MOC-9;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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