Intraoperative Monitoring
Conditions
Keywords
nociception monitoring, SPI, opioid consumption, gastric sleeve, analgesia
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.
Interventions
OTHERIntra-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.
Sponsors
Iuliu Hatieganu University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores on the visual analog scale during the first 90 minutes post-operatively | during the first 90 minutes post-operatively | Pain scores on the visual analog scale during the first 90 minutes post-operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | during surgery | the amount of fentanyl per LBW |
| Sevoflurane concentration | during surgery | mean MAC and sevoflurane concentration during surgery |
| Time from neuromuscular reversal to extubation | at the end of surgery | Time from neuromuscular reversal to extubation |
| Hemodinamic events | during surgery | an increase in heart rate or mean arterial pressure with more than 20% of the basal values (measured on the ward) |
| Rescue analgesia | in the first 90 minutes post-operatively | the need for rescue opioids during the first 90 minutes post-operatively |
Countries
Romania
Outcome results
None listed