NCT05884229

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

May 22, 2023

Last Update Submit

May 22, 2023

Conditions

Intraoperative Monitoring

Keywords

nociception monitoringSPIopioid consumptiongastric sleeveanalgesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Opioid consumption

    during surgery

  • Sevoflurane concentration

    during surgery

  • Time from neuromuscular reversal to extubation

    at the end of surgery

  • Hemodinamic events

    during surgery

  • Rescue analgesia

    in the first 90 minutes post-operatively

Study Arms (2)

Standard opioid administration

NO INTERVENTION

SPI-guided opioid administration

EXPERIMENTAL
Other: Intra-operative analgesia guided by SPI

Interventions

Intra-operative analgesia guided by SPIOTHER

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.

SPI-guided opioid administration

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • drugs that affect the autonomic nervous system
  • peripheral neuropathy
  • altered renal/hepatic function
  • chronic opioid use
  • use of vaso-active drugs intra-operatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Surgical Clinic, County Hospital

Cluj-Napoca, Romania

RECRUITING

Related Publications (8)

  • 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.

    PMID: 30916030BACKGROUND

  • 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.

    PMID: 22973178BACKGROUND

  • 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.

    PMID: 29857187BACKGROUND

  • 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.

    PMID: 23220856BACKGROUND

  • 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.

    PMID: 31437589BACKGROUND

  • 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.

    PMID: 34088270BACKGROUND

  • 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.

    PMID: 36140567BACKGROUND

  • 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.

    PMID: 30198405BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 1, 2023

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations

RO(1)