Analgesia, Nociceptive Pain, Pain, Acute
Conditions
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.
Interventions
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.
Sponsors
Wonkwang University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Investigator, Outcomes 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
Intervention model description
Prospective randomized and controlled study
Eligibility
Sex/Gender
MALE
Age
19 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP) | Immediately before administration of propofol (2mg/kg) | The correlation of preanesthetic ANI scores and incidence of PIP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of PIP | during anesthesia induction ( half-dose (1mg/kg) and full-dose of (2mg/kg) propofol administration) | 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) | Immediately before administration of propofol (2mg/kg) | The correlation of preanesthetic ANI scores and severity of PIP. |
Countries
South Korea
Outcome results
None listed