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

Wonkwang University Hospital

Status: Completed

Conditions: Nociceptive Pain; Pain, Acute; Analgesia

Treatments: Device: Analgesia/Nociception Index (ANI)

Study type: Interventional

Funder types: Other

Identifiers

NCT05049577

WonkwangUH8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: Male

Ages: 19 to 60 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

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.

Treatment:

Device: Analgesia/Nociception Index (ANI)

Remifentanil group

Experimental group

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

Treatment:

Device: Analgesia/Nociception Index (ANI)