Impact of Nociceptive-Level (NOL) Intraoperative Guided Analgesia During Gynecological Laparoscopic Surgery Under General Anesthesia

• Status: Completed
• Trial end date: 2021-09-15
• Target enrollment: 0
• Participant gender: Female

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 opioids compared to the Standard of Care reduces the total fentanyl consumption and the number of intraoperative administration of IV fentanyl during gynecological laparoscopic surgery and improves postoperative outcomes in PACU.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ciusss de L'Est de l'Île de Montréal
• Collaborator: Medasense Biometrics Ltd
• Treatments: Anesthetics; Fentanyl

Criteria

Inclusion Criteria:

1. Female age 18-75 years

2. ASA I-III

3. adult patients scheduled to undergo elective gynecological laparoscopic surgery (hysterectomy and uni- or bilateral oophorectomy) under general anesthesia

4. patient able to consent in the language of the including center

Exclusion Criteria:

1. use of any type of anesthesia other than general anesthesia (neuraxial, epidural analgesia or local regional anesthesia, e.g. transversus abdominal plane block...)

2. patients with non-regular sinus cardiac rhythm, implanted pacemakers, prescirbed antimuscarinic agents, alpha2-adrenergic agonists, beta1-adrenergic antagonists, and antiarrhythmic agents

3. emergent surgery

4. pregnancy/lactation. Pregnancy test will be performed in all women of child bearing age

5. BMI > 35 kg/m2

6. preoperative hemodynamic disturbance

7. central nervous system disorder (neurologic/ head trauma/ uncontrolled epileptic seizures)

8. drug or alcohol abuse within the last 6 months (for women, > 3 drinks on one occasion or >7 drinks during a week)

9. pre-operative chronic opioid use or chronic pain, equivalent to oxycodone 20mg per oral, per day for more than 6 weeks

10. chronic use of psychoactive drugs within 90 days prior to surgery

11. medical conditions qualifying for ASA III or IV:

1. untreated or persistent peripheral or central cardiovascular disease

2. severe pulmonary disease e.g. COPD gold 4, FEV< 1.0l/s, or (evidence of) elevated paCO2 > 6.0 kPa

3. significant hepatic disease with increased bilirubin, INR or low albumin

4. history of severe cardiac arrhythmia e.g. chronic atrial fibrillation

5. active pacemaker or defibrillator

12. allergy or intolerance to any of the study drugs

13. intraoperative cardiac arrhythmia