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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-06-30

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.

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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.

Conditions

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Pain, Acute Analgesia Nociceptive Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized and controlled study

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Analgesia/Nociception Index (ANI)

Intervention Type 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.

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

Group Type EXPERIMENTAL

Analgesia/Nociception Index (ANI)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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ANI MOC-9

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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes