Dataset Information

Comparative study of analgesia nociception index (ANI) vs. standard pharmacokinetic pattern for guiding intraoperative fentanyl administration among mastectomy patients.

ABSTRACT:

Background

The Analgesia Nociception Index (ANI) has been suggested as a non-invasive guide for analgesia. Our objective was to compare the efficacy of ANI vs. standard pharmacokinetic pattern for guiding intraoperative fentanyl administration.

Methods

This was a prospective, randomized, controlled study of adult female patients undergoing elective mastectomy under general anesthesia. The patients were randomized to the ANI-guided group receiving a loading dose of 75??g of fentanyl followed by 25??g when the ANI score was under 50. The Control group received the same loading dose followed by 25??g every 30?min with additional doses when there were signs of inadequate analgesia (viz., tachycardia or hypertension).

Results

Sixty patients-30 in each group-were recruited. Although the actual mean ANI score was higher in the ANI-guided than in the Control group (mean difference 2.2; 95% CI: 0.3 to 4.0, P =?0.022), there was no difference in the primary outcome-i.e., intraoperative fentanyl consumption (mean difference?-?4.2??g; 95% CI: -?24.7 to 16.4, P =?0.686 and?-?0.14??g·kg^-?1·h^-?1; 95% CI: -?0.31 to 0.03, P =?0.105). No difference between groups was shown for either intraoperative blood pressure and heart rate, or for postoperative outcomes (i.e., pain scores, morphine consumption, or sedation scores) in the postanesthesia care unit.

Conclusions

Intraoperative fentanyl administration guided by ANI was equivalent to that guided by a modified pharmacologic pattern. In a surgical model of mastectomy, the ANI-guided intraoperative administration of fentanyl had no impact on clinical outcomes.

Trial registration

The study was registered with ClinicalTrials.gov ( NCT03716453 ) on 21/10/2018.

SUBMITTER: Tribuddharat S

PROVIDER: S-EPMC7881489 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Comparative study of analgesia nociception index (ANI) vs. standard pharmacokinetic pattern for guiding intraoperative fentanyl administration among mastectomy patients.

Tribuddharat Sirirat S Sathitkarnmanee Thepakorn T Sukhong Pornlada P Thananun Maneerat M Promkhote Parinda P Nonlhaopol Duangthida D

BMC anesthesiology 20210213 1

<h4>Background</h4>The Analgesia Nociception Index (ANI) has been suggested as a non-invasive guide for analgesia. Our objective was to compare the efficacy of ANI vs. standard pharmacokinetic pattern for guiding intraoperative fentanyl administration.<h4>Methods</h4>This was a prospective, randomized, controlled study of adult female patients undergoing elective mastectomy under general anesthesia. The patients were randomized to the ANI-guided group receiving a loading dose of 75 μg of fentany ...[more]

PMID: 33581721

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Project description:Background:The clinical efficacy of fentanyl for pain control differs greatly across individuals. The purpose of this study was to investigate the impact of CYP3A4*1G polymorphism including wild-type homozygote (CYP3A4*1/*1, GG), mutant heterozygote (CYP3A4*1/*1G, GA), and mutant homozygote (CYP3A4*1G/*1G, AA) on fentanyl analgesia in Chinese patients undergoing hysteroscopy by the assessment of analgesia nociception index (ANI). Methods:A total of 200 gynecologic patients scheduled for elective hysteroscopy under general anesthesia at Peking University People's Hospital from May to December in 2017 were enrolled in this study. Venous blood was withdrawn for genotyping of CYP3A4*1G before operation. Fentanyl 1 ?g/kg was administered preoperatively followed by target-controlled infusion of propofol for induction and maintenance. Intraoperative analgesic efficacy of fentanyl was assessed by ANI monitoring at T0 (entering room), T1 (cervical dilation), T2 (start of cervical aspiration), and T3 (end of cervical aspiration) time points. The duration of propofol infusion and total dosage of propofol were recorded as well. Results:The patients were divided into three groups according to CYP3A4*1G polymorphism, including 143 in GG group, 47 in GA group, and 10 in AA group. There was no significant difference in clinical demographics among three groups. The frequency of CYP3A4*1G variant alleles accounted for 16.8% and the distribution of variant alleles was consistent with Hardy-Weinberg equilibrium. Using a multilevel model, ANI values at T1 (63.81 ± 19.61), T2 (63.63 ± 17.82), and T3 (65.68 ± 17.79) were significantly lower than that at T0 (77.16 ± 12.93) in the study population (F = 23.50, P < 0.001), suggesting that higher levels of pain at T1, T2, and T3 than T0. Patients with GG genotype showed significantly lower ANI than those with GA or AA genotypes during hysteroscopy under the same dose of fentanyl. Conclusion:CYP3A4*1G polymorphism associated with the analgesic efficacy of intraoperative fentanyl in the patients undergoing hysteroscopy under general anesthesia.

Project description:BackgroundSevere postoperative pain remains a major problem that is seen in 20 to 40% of patients. The Analgesia/Nociception Index (ANI) is a 0-100 index reflecting the relative parasympathetic activity allowing for intraoperative analgesia monitoring. We have previously shown that an ANI value < 50 immediately before extubation may predict the occurrence of immediate postoperative pain with good performance. We hypothesized that GOAL-Directed ANalgesia may provide reduced immediate postoperative pain and optimized intraoperative remifentanil administration (GOLDAN study).MethodsThe GOALDAN study is an international, multicenter, simple-blind, parallel, prospective, randomized, controlled, two-armed trial. Patients are randomly assigned in a 1:1 ratio in the control group or in the experimental group. Patients will be randomly allocated to either the intervention group (ANI) or the control group (standard care only). In the ANI group, the administration of remifentanil will be goal-directed targeting a 50-80 ANI range, with a prophylactic injection of morphine immediately after extubation if the case of ANI < 50. Our primary objective was to determine whether the prophylactic administration of morphine at the end of the procedure in patients at risk of immediate postoperative pain (ANI < 50 immediately before extubation) could reduce the incidence of the latter by 50% in the post-anesthetic care unit. Our secondary objective was to determine whether the intraoperative use of goal-directed analgesia with an ANI target of 50 to 80 could improve intraoperative hemodynamics and postoperative outcome.DiscussionBecause of the paucity of well-conducted trials, the authors believe that a randomized-controlled trial will improve the evidence for using analgesia monitoring during general anesthesia and strengthen current recommendations for intraoperative analgesia management.Trial registrationClinicalTrials.gov NCT03618082. Registered on 7 August 2018.

Project description:BackgroundGeneral anesthesia leads to different effects depending on the drugs used (hypnosis, analgesia, muscle relaxation). While there are validated methods for clinical monitoring and control of hypnosis and muscle relaxation in routine anesthesia, the assessment of analgesia is still mainly based on the interpretation of clinical vital parameters, such as heart rate, blood pressure, perspiration or intraoperative movements of the patient. The present clinical study investigated whether the use of a so-called nociception monitor to record the intraoperative need for analgesics is superior to the previous analysis of vital parameters. The analgesia nociception index (ANI; MDoloris, Lille, France) was used, which is one of several nociception monitors currently on the market for recording the sympathicovagal balance. In the case of the ANI, the measurement is based on the analysis of the heart rate variability (HRV) as a function of breathing. The index is given in the form of a dimensionless score between 0 and 100, where 0 stands for a lack of parasympathetic activity and 100 for a very strong parasympathetic activity. According to the manufacturer, a value between 50-70 under anesthesia corresponds to sufficient intraoperative analgesia.MethodsThis was a clinical prospective randomized study in which 110 patients who underwent laparoscopic hysterectomy under balanced anesthesia using propofol, fentanyl and atracurium for induction and sevoflurane and fentanyl for anesthesia maintenance, were divided into two groups. In the intervention group (ANI group), during the operation analgesics were administered with the aid of the ANI monitor (bolus of 0.1 mg fentanyl if the ANI was < 50), whereas in the comparison group analgesics were administered according to previous clinical parameters (vital parameters, intraoperative defensive movements). The groups were then compared with respect to intraoperative fentanyl consumption (primary outcome), postoperative pain and opioid-induced side effects (measured by the numeric rating scale [NRS]) as well as patient satisfaction on postoperative day 3 (secondary outcome).ResultsThe observations showed a higher total intraoperative consumption of fentanyl in the intervention group, due to a significantly higher number of individual doses (0.54 vs. 0.44 mg, p < 0.001). With respect to the other observation points, there were hardly any differences between the groups, neither with respect to the pain score nor the side effects in the recovery room. At most there was a trend towards a slightly lower pain score at the first measurement point in the recovery room (NRS at 15 min). In the patient survey on the postoperative day 3, there was a difference with respect to the subjectively described reduction in vigilance in the ANI group, but not other side effects or overall satisfaction with the pain therapy.ConclusionIn this group of patients the additional use of the ANI monitor for intraoperative control of analgesia led to an increased consumption of fentanyl compared to the comparison group, without having an impact on the postoperative pain score, opioid-induced side effects or patient satisfaction. An optimization of pain therapy through intraoperative use of the ANI monitoring in hysterectomy patients under balanced anesthesia with sevoflurane and fentanyl could therefore not be proven. Transferability of the results to a much older and/or sicker patient collective remains questionable.

Dataset Information

Comparative study of analgesia nociception index (ANI) vs. standard pharmacokinetic pattern for guiding intraoperative fentanyl administration among mastectomy patients.

Background

Methods

Results

Conclusions

Trial registration

Publications

Comparative study of analgesia nociception index (ANI) vs. standard pharmacokinetic pattern for guiding intraoperative fentanyl administration among mastectomy patients.

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