Influence of Nociception Level Monitor (NOL) Guided Analgesic Delivery on the Perioperative Course, Quality of Recovery and Hospital Stay in Robot-assisted Colorectal Surgery

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Being relatively new, the NOL monitor may offer interesting observations in perioperative nociception levels and appropriate analgesic consumption in diverse surgeries, including robot-assisted surgery. These observations may supplement the current efforts towards further advantages in rapid restitution. Therefore, the investigators planned a trial where intra-operative analgesics were guided using an NOL monitor to study if intra-operative NOL guidance influences peri-operative analgesic consumption, postoperative length of stay and quality of recovery of patients subjected for robot-assisted surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• American Society of Anaesthesiologists score III-IV

• Scheduled for elective major robot-assisted colorectal surgeries

Locations
Other Locations
Denmark
Anaesthesiology and Intensive Care Research Unit
RECRUITING
Aabenraa
Contact Information
Primary
Thomas Strøm
thomas.strom@rsyd.dk
+45 79 97 00 00
Backup
Rajesh Bhavsar
Rajesh.prabhakar.Bhavsar@rsyd.dk
+45 79 97 00 00
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 60
Treatments
Placebo_comparator: Standard Clinical Care Group
Hemodynamic changes outside of the normal range i.e., hypertension (systolic blood pressure greater than 140 mm Hg), tachycardia (heart rate greater than 90 min-1) and hypotension (mean arterial pressure less than 60 mm Hg) will be first assessed using the guidance of Bispectral index and Train of four monitors. Sufentanil in doses of 2.5 to 5 mcg (maximum of 0.6-1.2 mic/kg for the entire surgery) is administered if the Bispectral index and Train of four monitor values are within normal range and if required vasopressor infusion is used. Vasoconstrictors may be given as a continuous infusion of norepinephrine, or bolus doses of ephedrine or phenylephrine. Only when blood pressure remains, low additional crystalloids will be given. Finally, in case of bradycardia (heart rate less than 30 min-1), atropine may be given
Experimental: Nociception Level-guided Analgesia Group
In the nociception level-guided group, sufentanil will be administered to maintain a nociception level value between 10 and 25. In case the nociception level values rise greater than 25 for more than 60 s, additional 2.5 microgram sufentanil (if nociception level increase remained less than 45) or 5 micrograms (if nociception level increase greater than 45). Atropine will be administered when heart rate decreases less than 30 min-1. Because the nociception level may be sensitive to such medication, nociception level values will then not used for at least 5 min to guide analgesia, with the exception of norepinephrine as this drug will be given as continuous infusion
Sponsors
Leads: University of Southern Denmark

This content was sourced from clinicaltrials.gov