Status:
UNKNOWN
NoL and BIS Monitoring on Patients Recovery and Safety After Surgery
Lead Sponsor:
Maisonneuve-Rosemont Hospital
Collaborating Sponsors:
Canadian Anesthesiologists' Society
Medasense Biometrics Ltd
Conditions:
Pain
Anesthesia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
So far, only vital signs (mostly, blood pressure and heart rate) helped the anesthesiologist to administer hypnotic agents or analgesics. Many devices have offered pain monitoring for anesthetized pat...
Detailed Description
Hypothesis is that the intraoperative use of the combination of 1) the NoL index (given by the PMD200TM monitor, Medasense LTD inc, Ramat, Israel) to monitor pain levels and to guide opioids' administ...
Eligibility Criteria
Inclusion
- ASA status I, II or III
- Patients aged 18 years
- Colo-rectal surgery
- Duration and type of surgery requiring an epidural analgesia via an epidural catheter placed prior the general anesthesia induction and an arterial line placed after induction of general anesthesia (classical management of ERAS program patients in our center)
Exclusion
- chronic arhythmic condition
- chronic pain
- Adverse events prompting termination of protocol:
- Unexpected difficult airway requesting excessive, possibly painful airway manipulations.
- Unexpected surgical complications requiring strong haemodynamic support (transfusions, volume challenges, vasopressors, inotropic drugs)
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03410485
Start Date
October 1 2016
End Date
December 1 2018
Last Update
January 25 2018
Active Locations (1)
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1
Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal
Montreal, Quebec, Canada, H1T2M4