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

NCT03776838 | Completed Phase 4

• 1 other identifier: 2019-1534
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Gynecologic Laparoscopic Surgery; Hysterectomy; Oophorectomy

Keywords

NOL monitoring; anesthesia; fentanyl consumption; intraoperative

Outcome Measures

Primary Outcomes (2)

• Change of intraoperative IV fentanyl consumption in the Soc+NOL guided group compared to the SoC guided group. Total consumption of fentanyl in mcg.

  Change of intraoperative IV fentanyl consumption in the SoC+NOL guided group compared to the SoC guided group.

  Intra-operative

• Change of frequency of intraoperative IV fentanyl administration in the Soc+NOL guided group compared to the SoC guided group. Frequency is in minutes

  Change of frequency of intraoperative IV fentanyl administration in the Soc+NOL guided group compared to the SoC guided group.

  Intra-operative

Secondary Outcomes (45)

• Change of post-operative IV hydromorphone consumption. Total consumption of hydromorphone in mcg.

  PACU stay (1.5 hours)

• Assessment of post operative pain at rest at T0 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10

  PACU entrance

• Assessment of post operative pain at rest at T15 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10

  15 min after PACU entrance

• Assessment of post operative pain at rest at T30 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10

  30 min after PACU entrance

• Assessment of post operative pain at rest at T45 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10

  45 min after PACU entrance

Study Arms (2)

SoC+NOL analgesia guided fentanyl administration

EXPERIMENTAL

A bolus of 2 mcg/kg of IV Fentanyl will be given at the induction of the anesthesia. A bolus of 1 mcg/kg of IV Fentanyl will be given at the time of incision. During surgery, administration of 0.5 mcg/kg of IV Fentanyl will be administered following a pre determinate algorithm based on NOL index + heart rate + mean arterial blood pressure variations. Intervention is NOL monitoring in this group that will help to guide intravenous administration of fentanyl during surgery.

Drug: Intravenous Fentanyl guided by SoC+NOL

SoC analgesia guided group

ACTIVE COMPARATOR

A bolus of IV Fentanyl at the discretion of a physician will be given at the induction of the anesthesia. A bolus of IV Fentanyl at the discretion of a physician will be given at the time of incision. During surgery, administration of IV Fentanyl at the discretion of a physician will be administred following a pre determinated algorithm based on heart rate + mean arterial blood pressure variations. Intervention will be here to use Heart rate and blood pressure to administer intraoperative intravenous fentanyl.

Drug: Intravenous Fentanyl guided by SoC

Interventions

Intravenous Fentanyl guided by SoC+NOL DRUG

Predeterminated bolus of IV Fentanyl will be given at the induction of anesthesia (2 mcg/kg), at the time of incision (1 mcg/kg). During surgery, administration of 0.5 mcg/kg of IV Fentanyl will be administred following a pre determinated algorithm based on NOL index + heart rate + mean arterial blood pressure variations.

SoC+NOL analgesia guided fentanyl administration

Intravenous Fentanyl guided by SoC DRUG

Bolus of IV Fentanyl at the discretion of a physician will be given at the induction of anesthesia, and at the time of incision. During surgery, administration of IV Fentanyl at the discretion of a physician will be administred following a pre determinated algorithm based on heart rate + mean arterial blood pressure variations.

SoC analgesia guided group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Medasense Biometrics Ltd: collaborator

Study Sites (1)

Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montréal

Montreal East, Quebec, H1T2M4, Canada

Location

Related Publications (2)

• Morisson L, Nadeau-Vallee M, Espitalier F, Laferriere-Langlois P, Idrissi M, Lahrichi N, Gelinas C, Verdonck O, Richebe P. Prediction of acute postoperative pain based on intraoperative nociception level (NOL) index values: the impact of machine learning-based analysis. J Clin Monit Comput. 2023 Feb;37(1):337-344. doi: 10.1007/s10877-022-00897-z. Epub 2022 Aug 4.

  PMID: 35925430 DERIVED

• Ghiyasinasab M, Morisson L, Laferriere-Langlois P, Geraldo-Demers MA, Gelinas C, Nadeau-Vallee M, Verdonck O, Lahrichi N, Richebe P. Identification of the intraoperative antinociceptive effect of intravenous fentanyl using the Nociception Level (NOL) index versus clinical parameters in patients undergoing gynecological laparoscopic surgery: A secondary analysis of the NOLGYN study. Anaesth Crit Care Pain Med. 2022 Aug;41(4):101102. doi: 10.1016/j.accpm.2022.101102. Epub 2022 May 25.

  PMID: 35643392 DERIVED

Study Officials

• Philippe PR Richebé, MD PhD

  CIUSSS Est de l'île de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomization into group SoC + NOL vs SoC will be done prior to the entrance in the OR, the day of the surgery
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD, Director of Research

Model Details: 2 groups of patients. Randomization into group SoC + NOL vs SoC according to randomization list for a total number of 70 patients

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 17, 2018
• Study Start: November 30, 2018
• Primary Completion: December 6, 2019
• Study Completion: September 15, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-10

Locations

CA (1)