The Effect of SPI (Surgical Pleth Index) - Guided Anaesthesia on Opioid Consumption in Gastric Sleeve Surgery

Intraoperative Monitoring Clinical Trial

Official title:

The Effect of SPI (Surgical Pleth Index) - Guided Anaesthesia Versus Conventional Analgesia on Opioid Consumption Under Multimodal Analgesia in Gastric Sleeve Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884229
• Other study ID #: 1
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2023
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients scheduled to laparoscopic gastric sleeve surgery in First Surgical Clinic, Cluj-Napoca County Hospital

Exclusion Criteria:

• drugs that affect the autonomic nervous system

• peripheral neuropathy

• altered renal/hepatic function

• chronic opioid use

• use of vaso-active drugs intra-operatively

Related Conditions & MeSH terms

• Intraoperative Monitoring

Intervention

Other:
• Intra-operative analgesia guided by SPI
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.

Locations

Country	Name	City	State
Romania	First Surgical Clinic, County Hospital	Cluj-Napoca

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Opioid consumption	the amount of fentanyl per LBW	during surgery
Secondary	Sevoflurane concentration	mean MAC and sevoflurane concentration during surgery	during surgery
Secondary	Time from neuromuscular reversal to extubation	Time from neuromuscular reversal to extubation	at the end of surgery
Secondary	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
Secondary	Rescue analgesia	the need for rescue opioids during the first 90 minutes post-operatively	in the first 90 minutes post-operatively