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...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-12-01
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| Series: | BJA Open |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772609622001113 |
| _version_ | 1798004777248882688 |
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| author | Yuma Kadoya Nobuhiro Tanaka Takanori Suzuka Takayuki Yamanaka Mitsuru Ida Yusuke Naito Shota Suzuki Shu Kasama Naoki Ozu Masahiko Kawaguchi |
| author_facet | Yuma Kadoya Nobuhiro Tanaka Takanori Suzuka Takayuki Yamanaka Mitsuru Ida Yusuke Naito Shota Suzuki Shu Kasama Naoki Ozu Masahiko Kawaguchi |
| author_sort | Yuma Kadoya |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-04-11T12:29:52Z |
| format | Article |
| id | doaj.art-23d88382a6074548af4de48c8dbccb47 |
| institution | Directory Open Access Journal |
| issn | 2772-6096 |
| language | English |
| last_indexed | 2024-04-11T12:29:52Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | BJA Open |
| spelling | doaj.art-23d88382a6074548af4de48c8dbccb472022-12-22T04:23:48ZengElsevierBJA Open2772-60962022-12-014100112Effect 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 trialYuma Kadoya0Nobuhiro Tanaka1Takanori Suzuka2Takayuki Yamanaka3Mitsuru Ida4Yusuke Naito5Shota Suzuki6Shu Kasama7Naoki Ozu8Masahiko Kawaguchi9Department of Anaesthesiology, Nara Medical University, Kashihara, Nara, JapanDepartment of Anaesthesiology, Nara Medical University, Kashihara, Nara, Japan; Corresponding author.Department of Anaesthesiology, Nara Medical University, Kashihara, Nara, JapanDepartment of Anaesthesiology, Nara Medical University, Kashihara, Nara, JapanDepartment of Anaesthesiology, Nara Medical University, Kashihara, Nara, JapanDepartment of Anaesthesiology, Nara Medical University, Kashihara, Nara, JapanInstitute for Clinical and Translational Science, Nara Medical University Hospital, Kashihara, Nara, JapanInstitute for Clinical and Translational Science, Nara Medical University Hospital, Kashihara, Nara, JapanInstitute for Clinical and Translational Science, Nara Medical University Hospital, Kashihara, Nara, JapanDepartment of Anaesthesiology, Nara Medical University, Kashihara, Nara, JapanBackground: 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.http://www.sciencedirect.com/science/article/pii/S2772609622001113inflammatory biomarkernociception level-guided anaesthesianociception monitoropioid consumptionrobot-assisted laparoscopic radical prostatectomy |
| spellingShingle | Yuma Kadoya Nobuhiro Tanaka Takanori Suzuka Takayuki Yamanaka Mitsuru Ida Yusuke Naito Shota Suzuki Shu Kasama Naoki Ozu Masahiko Kawaguchi 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 BJA Open inflammatory biomarker nociception level-guided anaesthesia nociception monitor opioid consumption robot-assisted laparoscopic radical prostatectomy |
| 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 | inflammatory biomarker nociception level-guided anaesthesia nociception monitor opioid consumption robot-assisted laparoscopic radical prostatectomy |
| url | http://www.sciencedirect.com/science/article/pii/S2772609622001113 |
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