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Effect of NOciception Level-Directed analgesic management on Opioid usage in Robot-assisted laparoscopic radical prostatectomy (NOLDOR): study protocol for a single-centre single-blinded randomised controlled trial
BACKGROUND: The nociception level (NOL) index discriminates noxious stimuli during surgery with high sensitivity and specificity. Although some studies have reported that a NOL-directed opioid protocol reduces intraoperative opioid consumption, one study implied that it might cause an unintended inc...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10430810/ https://www.ncbi.nlm.nih.gov/pubmed/37588782 http://dx.doi.org/10.1016/j.bjao.2022.100112 |
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author | Kadoya, Yuma Tanaka, Nobuhiro Suzuka, Takanori Yamanaka, Takayuki Ida, Mitsuru Naito, Yusuke Suzuki, Shota Kasama, Shu Ozu, Naoki Kawaguchi, Masahiko |
author_facet | Kadoya, Yuma Tanaka, Nobuhiro Suzuka, Takanori Yamanaka, Takayuki Ida, Mitsuru Naito, Yusuke Suzuki, Shota Kasama, Shu Ozu, Naoki Kawaguchi, Masahiko |
author_sort | Kadoya, Yuma |
collection | PubMed |
description | BACKGROUND: The nociception level (NOL) index discriminates noxious stimuli during surgery with high sensitivity and specificity. Although some studies have reported that a NOL-directed opioid protocol reduces intraoperative opioid consumption, one study implied that it might cause an unintended increase in the stress response. Therefore, we designed a study to investigate the effects of the NOL-directed opioid protocol and measure inflammatory biomarkers. METHODS: This single-centre RCT will enrol 54 patients undergoing robot-assisted laparoscopic radical prostatectomy. Eligible patients will be randomly allocated to receive (i) NOL-directed intraoperative opioid management (NOL group) or (ii) conventional intraoperative analgesic management (control group). The remifentanil infusion rate will be determined solely using the NOL index during surgery in the NOL group. The primary outcome will be the mean intraoperative remifentanil infusion rate. Secondary outcomes will include the plasma concentrations of three perioperative inflammatory biomarkers (interleukin-6, C-reactive protein, and cortisol) and the variation in the NOL index at the start of pneumoperitoneum and with postural changes. CONCLUSIONS: This study is expected to accumulate evidence on the effects of NOL-directed analgesic opioid protocol and provide additional evidence regarding the variability of stress responses and the character of the NOL index. CLINICAL TRIAL REGISTRATION: JRCTs052220034. |
format | Online Article Text |
id | pubmed-10430810 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-104308102023-08-16 Effect of NOciception Level-Directed analgesic management on Opioid usage in Robot-assisted laparoscopic radical prostatectomy (NOLDOR): study protocol for a single-centre single-blinded randomised controlled trial Kadoya, Yuma Tanaka, Nobuhiro Suzuka, Takanori Yamanaka, Takayuki Ida, Mitsuru Naito, Yusuke Suzuki, Shota Kasama, Shu Ozu, Naoki Kawaguchi, Masahiko BJA Open Clinical Trial Protocol BACKGROUND: The nociception level (NOL) index discriminates noxious stimuli during surgery with high sensitivity and specificity. Although some studies have reported that a NOL-directed opioid protocol reduces intraoperative opioid consumption, one study implied that it might cause an unintended increase in the stress response. Therefore, we designed a study to investigate the effects of the NOL-directed opioid protocol and measure inflammatory biomarkers. METHODS: This single-centre RCT will enrol 54 patients undergoing robot-assisted laparoscopic radical prostatectomy. Eligible patients will be randomly allocated to receive (i) NOL-directed intraoperative opioid management (NOL group) or (ii) conventional intraoperative analgesic management (control group). The remifentanil infusion rate will be determined solely using the NOL index during surgery in the NOL group. The primary outcome will be the mean intraoperative remifentanil infusion rate. Secondary outcomes will include the plasma concentrations of three perioperative inflammatory biomarkers (interleukin-6, C-reactive protein, and cortisol) and the variation in the NOL index at the start of pneumoperitoneum and with postural changes. CONCLUSIONS: This study is expected to accumulate evidence on the effects of NOL-directed analgesic opioid protocol and provide additional evidence regarding the variability of stress responses and the character of the NOL index. CLINICAL TRIAL REGISTRATION: JRCTs052220034. Elsevier 2022-11-21 /pmc/articles/PMC10430810/ /pubmed/37588782 http://dx.doi.org/10.1016/j.bjao.2022.100112 Text en © 2022 The Author(s) https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Clinical Trial Protocol Kadoya, Yuma Tanaka, Nobuhiro Suzuka, Takanori Yamanaka, Takayuki Ida, Mitsuru Naito, Yusuke Suzuki, Shota Kasama, Shu Ozu, Naoki Kawaguchi, Masahiko Effect of NOciception Level-Directed analgesic management on Opioid usage in Robot-assisted laparoscopic radical prostatectomy (NOLDOR): study protocol for a single-centre single-blinded randomised controlled trial |
title | Effect of NOciception Level-Directed analgesic management on Opioid usage in Robot-assisted laparoscopic radical prostatectomy (NOLDOR): study protocol for a single-centre single-blinded randomised controlled trial |
title_full | Effect of NOciception Level-Directed analgesic management on Opioid usage in Robot-assisted laparoscopic radical prostatectomy (NOLDOR): study protocol for a single-centre single-blinded randomised controlled trial |
title_fullStr | Effect of NOciception Level-Directed analgesic management on Opioid usage in Robot-assisted laparoscopic radical prostatectomy (NOLDOR): study protocol for a single-centre single-blinded randomised controlled trial |
title_full_unstemmed | Effect of NOciception Level-Directed analgesic management on Opioid usage in Robot-assisted laparoscopic radical prostatectomy (NOLDOR): study protocol for a single-centre single-blinded randomised controlled trial |
title_short | Effect of NOciception Level-Directed analgesic management on Opioid usage in Robot-assisted laparoscopic radical prostatectomy (NOLDOR): study protocol for a single-centre single-blinded randomised controlled trial |
title_sort | effect of nociception level-directed analgesic management on opioid usage in robot-assisted laparoscopic radical prostatectomy (noldor): study protocol for a single-centre single-blinded randomised controlled trial |
topic | Clinical Trial Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10430810/ https://www.ncbi.nlm.nih.gov/pubmed/37588782 http://dx.doi.org/10.1016/j.bjao.2022.100112 |
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