Status:
COMPLETED
The Use of Surgical Pleth Index in Guiding Anesthesia in Gastroenterological Surgery
Lead Sponsor:
Tampere University Hospital
Collaborating Sponsors:
general electric healthcare Finland
Conditions:
Intraoperative Complications
Intraoperative Hypotension
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Surgical Pleth Index (SPI) is an intraoperative monitor aimed into detection of nociception and guidance of intraoperative opioid administration. Using such a device opioid administration could be pot...
Detailed Description
Patients are extensively monitored intraoperatively. Even though there are monitors for the measurement of nociception, it has not gained wide acceptance partly because of limited and scarce evidence ...
Eligibility Criteria
Inclusion
- Able to provide a written informed consent
- Age 50 years or above
- Laparoscopic or laparotomic surgery requiring intubation with an expected intraoperative time at least two hours.
- ASA classification 1-3
Exclusion
- Implanted cardiac pacemaker or known condition with irregular heart rate at the time of inclusion or induction
- Chronic use of opioids
- BMI \>35
- Known allergy for study medications
- Over 5 extrasystoles per minute at the time of induction or inclusion
- The use of epidural catheter during the last one hour before surgery or need for catheter intraoperatively (if new catheter is placed at the beginning of surgery test dosage may be used without the need for patient exclusion)
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04519203
Start Date
September 9 2020
End Date
November 1 2021
Last Update
November 25 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tampere University Hospital
Tampere, Finland, 33521