Status:
COMPLETED
Impact of Nociceptive-Level (NOL) Intraoperative Guided Analgesia During Gynecological Laparoscopic Surgery Under General Anesthesia
Lead Sponsor:
Ciusss de L'Est de l'Île de Montréal
Collaborating Sponsors:
Medasense Biometrics Ltd
Conditions:
Gynecologic Laparoscopic Surgery
Hysterectomy
Eligibility:
FEMALE
18-75 years
Phase:
PHASE4
Brief Summary
The aim of the present study is to show that the use of the NOL device in addition to the Standard of Care (based on mean arterial blood pressure and heart rate values) to guide the administration of ...
Detailed Description
Hypothesis: We hypothesize that the group who will be administered intraoperative fentanyl based on NOL + mean arterial blood pressure (MABP) + heart rate (HR) values (SoC+NOL group) versus on MABP an...
Eligibility Criteria
Inclusion
- Female age 18-75 years
- ASA I-III
- adult patients scheduled to undergo elective gynecological laparoscopic surgery (hysterectomy and uni- or bilateral oophorectomy) under general anesthesia
- patient able to consent in the language of the including center
Exclusion
- use of any type of anesthesia other than general anesthesia (neuraxial, epidural analgesia or local regional anesthesia, e.g. transversus abdominal plane block...)
- patients with non-regular sinus cardiac rhythm, implanted pacemakers, prescirbed antimuscarinic agents, alpha2-adrenergic agonists, beta1-adrenergic antagonists, and antiarrhythmic agents
- emergent surgery
- pregnancy/lactation. Pregnancy test will be performed in all women of child bearing age
- BMI \> 35 kg/m2
- preoperative hemodynamic disturbance
- central nervous system disorder (neurologic/ head trauma/ uncontrolled epileptic seizures)
- drug or alcohol abuse within the last 6 months (for women, \> 3 drinks on one occasion or \>7 drinks during a week)
- pre-operative chronic opioid use or chronic pain, equivalent to oxycodone 20mg per oral, per day for more than 6 weeks
- chronic use of psychoactive drugs within 90 days prior to surgery
- medical conditions qualifying for ASA III or IV:
- untreated or persistent peripheral or central cardiovascular disease
- severe pulmonary disease e.g. COPD gold 4, FEV\< 1.0l/s, or (evidence of) elevated paCO2 \> 6.0 kPa
- significant hepatic disease with increased bilirubin, INR or low albumin
- history of severe cardiac arrhythmia e.g. chronic atrial fibrillation
- active pacemaker or defibrillator
- allergy or intolerance to any of the study drugs
- intraoperative cardiac arrhythmia
Key Trial Info
Start Date :
November 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03776838
Start Date
November 30 2018
End Date
September 15 2021
Last Update
October 4 2021
Active Locations (1)
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1
Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montréal
Montreal East, Quebec, Canada, H1T2M4