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This is a unicentric, prospective randomised trial that aims to evaluate the role of intra-operative monitoring of nociception through SPI (Surgical Pleth Index) in guiding analgesia and reducing opioid consumption in obese patients undergoing bariatric surgery.
We aim to enrol 40 patients having laparoscopic gastric sleeve surgery in the Cluj-Napoca County Hospital. They will be randomised into two groups, one with opioid administration during surgery guided by SPI, and the other one guided by anesthetist experience. We will monitor opioid consumption, pain scores during the first 90 minutes post-operatively, hemodinamic events during surgery and the duration between reversal of neuromuscular block and extubation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard opioid administration | No Intervention | ||
| SPI-guided opioid administration | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-operative analgesia guided by SPI | Other | In the SPI-guided group, when SPI is higher than 50 for the first time and for more than 3 minutes, we will administer 1,0 μg/kg of fentanyl LBW. When SPI is again higher than 50 and for more than 5 minutes, we will re-administer 1,0 μg/kg of fentanyl LBW. We will repeat until SPI is between 20-50. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores on the visual analog scale during the first 90 minutes post-operatively | Pain scores on the visual analog scale during the first 90 minutes post-operatively | during the first 90 minutes post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | the amount of fentanyl per LBW | during surgery |
| Sevoflurane concentration | mean MAC and sevoflurane concentration during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Surgical Clinic, County Hospital | Recruiting | Cluj-Napoca | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30916030 | Background | Ledowski T, Schneider M, Gruenewald M, Goyal RK, Teo SR, Hruby J. Surgical pleth index: prospective validation of the score to predict moderate-to-severe postoperative pain. Br J Anaesth. 2019 Aug;123(2):e328-e332. doi: 10.1016/j.bja.2018.10.066. Epub 2019 Mar 12. | |
| 22973178 | Background | Chen X, Thee C, Gruenewald M, Ilies C, Hocker J, Hanss R, Steinfath M, Bein B. Correlation of surgical pleth index with stress hormones during propofol-remifentanil anaesthesia. ScientificWorldJournal. 2012;2012:879158. doi: 10.1100/2012/879158. Epub 2012 Sep 2. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| during surgery |
| Time from neuromuscular reversal to extubation | Time from neuromuscular reversal to extubation | at the end of surgery |
| Hemodinamic events | an increase in heart rate or mean arterial pressure with more than 20% of the basal values (measured on the ward) | during surgery |
| Rescue analgesia | the need for rescue opioids during the first 90 minutes post-operatively | in the first 90 minutes post-operatively |
| 29857187 | Background | Bapteste L, Szostek AS, Chassard D, Desgranges FP, Bouvet L. Can intraoperative Surgical Pleth Index values be predictive of acute postoperative pain? Anaesth Crit Care Pain Med. 2019 Aug;38(4):391-392. doi: 10.1016/j.accpm.2018.05.004. Epub 2018 May 29. No abstract available. |
| 23220856 | Background | Bergmann I, Gohner A, Crozier TA, Hesjedal B, Wiese CH, Popov AF, Bauer M, Hinz JM. Surgical pleth index-guided remifentanil administration reduces remifentanil and propofol consumption and shortens recovery times in outpatient anaesthesia. Br J Anaesth. 2013 Apr;110(4):622-8. doi: 10.1093/bja/aes426. Epub 2012 Dec 5. |
| 31437589 | Background | Chen IW, Lin CM, Chang YJ, Chen JY, Wu ZF, Ho CN, Feng IJ, Sun CK, Hung KC. Association of surgical pleth index with late postoperative analgesic requirement: A retrospective study. J Clin Anesth. 2020 Mar;60:12-13. doi: 10.1016/j.jclinane.2019.08.022. Epub 2019 Aug 19. No abstract available. |
| 34088270 | Background | Guo J, Zhu W, Shi Q, Bao F, Xu J. Effect of surgical pleth index-guided analgesia versus conventional analgesia techniques on fentanyl consumption under multimodal analgesia in laparoscopic cholecystectomy: a prospective, randomized and controlled study. BMC Anesthesiol. 2021 Jun 4;21(1):167. doi: 10.1186/s12871-021-01366-x. |
| 36140567 | Background | Hung KC, Huang YT, Kuo JR, Hsu CW, Yew M, Chen JY, Lin MC, Chen IW, Sun CK. Elevated Surgical Pleth Index at the End of Surgery Is Associated with Postoperative Moderate-to-Severe Pain: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2022 Sep 6;12(9):2167. doi: 10.3390/diagnostics12092167. |
| 30198405 | Background | Won YJ, Lim BG, Kim YS, Lee M, Kim H. Usefulness of surgical pleth index-guided analgesia during general anesthesia: a systematic review and meta-analysis of randomized controlled trials. J Int Med Res. 2018 Nov;46(11):4386-4398. doi: 10.1177/0300060518796749. Epub 2018 Sep 9. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |