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NOL Index to Compare the Intraoperative Analgesic Effect of Propofol Versus Sevoflurane (PROSEVNOL)

Primary Purpose

Nociceptive Pain, Anesthesia

Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Sponsored by
Ciusss de L'Est de l'Île de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nociceptive Pain focused on measuring NOL index

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA status I, II or III
  • Age 18 years or older
  • Elective surgery under general anesthesia.
  • Good understanding of English or French language

Non-inclusion Criteria

  • Ongoing Coronary artery disease
  • Patients with non-regular sinus cardiac rhythm, implanted pacemakers, prescribed antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists and antiarrhythmic agents
  • Emergent surgery
  • Pregnancy/lactation
  • Preoperative hemodynamic disturbance
  • Central nervous system disorder (neurologic/head trauma/uncontrolled epileptic seizures)
  • Patient refusal
  • Drug or alcohol abuse within the last 6 months
  • Chronic use of psychoactive drugs
  • Pre-operative chronic opioid use or chronic pain, equivalent to oxycodone 20mg per oral, per day for more than 6 weeks
  • History of psychiatric diseases or psychological problems
  • Allergy or intolerance to any of the study drugs

Exclusion Criteria:

  • Unexpected difficult airway requesting excessive, possibly painful airway manipulations.
  • Intraoperative unexpected complications requiring strong hemodynamic support (transfusions, vasopressors, inotropes)

Sites / Locations

  • CIUSSS de l'Est de l'Ile de MontrealRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Propofol group

Sevoflurane group

Arm Description

Induction and maintenance of general anesthesia using propofol

Induction and maintenance of general anesthesia using sevoflurane

Outcomes

Primary Outcome Measures

Delta NOL (no unit for the NOL index)
To compare the variation of NOL (delta NOL) after tetanic stimulation under general anesthesia based on propofol versus sevoflurane

Secondary Outcome Measures

Delta Heart Rate (beat per minute)
To compare the variation of heart rate after tetanic stimulation under general anesthesia based on propofol versus sevoflurane
Delta Mean Arterial Blood Pressure (unit: mmHg)
To compare the variation of mean arterial blood pressure (MABP) after tetanic stimulation under general anesthesia based on propofol versus sevoflurane
Delta BIS (no unit for BIS index)
To compare the variation of bispectral index (BIS) after tetanic stimulation under general anesthesia based on propofol versus sevoflurane
Peak value of NOL (no unit)
To compare the peak value of NOL after tetanic stimulation under general anesthesia based on propofol versus sevoflurane
Peak value of Heart Rate (unit: beat per minute)
To compare the peak value of heart rate after tetanic stimulation under general anesthesia based on propofol versus sevoflurane
Peak value of Mean Arterial Blood Pressure (unit: mmHg)
To compare the peak value of mean arterial blood pressure (MABP) after tetanic stimulation under general anesthesia based on propofol versus sevoflurane
Peak value of BIS (no unit)
To compare the peak value of bispectral index (BIS) after tetanic stimulation under general anesthesia based on propofol versus sevoflurane
Area Under the Curve for NOL for Propofol Versus Sevoflurane (no unit)
To compare the area under the curve between propofol and sevoflurane between the beginning of stimulation and 3 minutes after stimulation
Area Under the Curve for Heart Rate for Propofol Versus Sevoflurane (no unit)
To compare the area under the curve between propofol and sevoflurane between the beginning of stimulation and 3 minutes after stimulation
Area Under the Curve for Mean Arterial Blood Pressure for Propofol Versus Sevoflurane (no unit)
To compare the area under the curve between propofol and sevoflurane between the beginning of stimulation and 3 minutes after stimulation
Area Under the Curve for BIS for Propofol Versus Sevoflurane (no unit)
To compare the area under the curve between propofol and sevoflurane between the beginning of stimulation and 3 minutes after stimulation
Total Dose of Remifentanil (unit: mcg)
Total dose of remifentanil in mcg from induction of anesthesia until tracheal extubation
Total Dose of Propofol (unit: mg)
Total dose of propofol in mg from induction of anesthesia until tracheal extubation in Propofol group
Total Dose of Sevoflurane (unit: mL)
Total dose of sevoflurane in mL from induction of anesthesia until tracheal extubation in Sevoflurane group
Total Dose of Hydromorphone in post-anesthesia care unit (PACU) (unit: mg)
Total dose of hydromorphone in mg in post-anesthesia care unit
post-anesthesia care unit (PACU) Pain Scores at Rest (scale from 0 to 10)
Pain scores on a scale from 0 to 10 at rest in post-anesthesia care unit
post-anesthesia care unit (PACU) Pain Scores during Cough (scale from 0 to 10)
Pain scores on a scale from 0 to 10 during cough effort in post-anesthesia care unit

Full Information

First Posted
September 21, 2020
Last Updated
April 4, 2022
Sponsor
Ciusss de L'Est de l'Île de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT04567160
Brief Title
NOL Index to Compare the Intraoperative Analgesic Effect of Propofol Versus Sevoflurane
Acronym
PROSEVNOL
Official Title
Use of the NOL Index to Compare the Intraoperative Analgesic Effect of Propofol Versus Sevoflurane After Standardized Stimulation in Patients Under General Anesthesia. The PROSEVNOL Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ciusss de L'Est de l'Île de Montréal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this prospective randomized controlled study is to compare the analgesic properties of propofol and sevoflurane using variation of the NOL index and standard monitoring (Heart Rate and Mean Arterial Blood Pressure) when patients under general anaesthesia with either agents are subjected to a standardized painful stimulus (a tetanic stimulation over the ulnar nerve at 70 mA, 100 Hz for 30 seconds).
Detailed Description
This study proposes a research design that compare the analgesic properties of two commonly used agents for induction and maintenance of the hypnotic component of anesthesia: propofol versus sevoflurane. Using the NOL index to quantitatively monitor nociception, it is expected to see a difference in response to a standardized electrical and tetanic stimulus during general anesthesia maintained with either agents. Hypothesis is that magnitude of the variation and/or the value of the NOL Index following a standardized nociceptive stimulus is lower when general anesthesia is based on propofol rather than on sevoflurane. Induction of general anesthesia will differ depending in which group the patient belongs. In the propofol group, general anesthesia will be induced using target-controlled infusion (TCI) of propofol and remifentanil. In the sevoflurane group, induction of general anesthesia will be carried out by spontaneous breathing through a mask while progressively opening up the dial of the sevoflurane vaporizer up to 8%. Like in the propofol group, target-controlled infusion of remifentanil is simultaneously started to reach an initial target predicted effect-site concentration of 3 ng/mL. Vaporizer is adjusted when gas equilibration reaches the patient-specific concentration 1.0 MAC of sevoflurane. At this point, noxious stimulation will be delayed at least 10 minutes after TCI remifentanil is paused to allow for the remifentanil to be cleared out and to ensure brain-alveolar equilibration of sevoflurane (sevoflurane group). Measurements of the NOL Index, BIS, HR and MAP start 1 minute before applying noxious stimulus (prestimulation period). Means of the data collected during that period will constitute the basal values for NOL and HR before stimulation. After this stand-by period, electric stimulation is applied. This will consist in a standardized tetanic stimulation to the ulnar nerve of the non-dominant forearm delivered by a routine nerve stimulator at a frequency of 100 Hz and a current of 70 mA for a duration of 30 seconds. Measurements of the NOL Index, BIS, HR and MAP will continue during 3 minutes after (poststimulation period). This window of recording has to be free of any other external stimulation as it could produce noise disturbance on recorded values. After the stimulation, all the monitors will be used to guide intraoperative administration of hypnotic agents and analgesics. Total consumption of hypnotics and opioids will be recorded for the duration of surgery. Postoperative assessment of pain and opioid consumption will be done in post anesthesia care unit as exploratory outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nociceptive Pain, Anesthesia
Keywords
NOL index

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled parallel open label study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propofol group
Arm Type
Active Comparator
Arm Description
Induction and maintenance of general anesthesia using propofol
Arm Title
Sevoflurane group
Arm Type
Active Comparator
Arm Description
Induction and maintenance of general anesthesia using sevoflurane
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
In the propofol group, general anesthesia will be induced using target-controlled infusion (TCI) of propofol and remifentanil. Marsh pharmacokinetic model will be used to set the initial target predicted effect-site concentration of propofol at 3.0 mcg/ml in flash mode. Simultaneously, target-controlled infusion of remifentanil will be started to reach an initial target predicted effect-site concentration of 3 ng/mL using the Minto pharmacokinetic model. After tracheal intubation, TCI of remifentanil is paused.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
In the sevoflurane group, induction of general anesthesia will be carried out by spontaneous breathing through a mask while progressively opening up the dial of the sevoflurane vaporizer up to 8%. Like in the propofol group, target-controlled infusion of remifentanil is simultaneously started to reach an initial target predicted effect-site concentration of 3 ng/mL. Vaporizer is adjusted when gas equilibration reaches the patient-specific concentration 1.0 MAC of sevoflurane. After tracheal intubation, TCI of remifentanil is paused.
Primary Outcome Measure Information:
Title
Delta NOL (no unit for the NOL index)
Description
To compare the variation of NOL (delta NOL) after tetanic stimulation under general anesthesia based on propofol versus sevoflurane
Time Frame
From 1 minute before to 3 minutes after tetanic stimulation for each patient
Secondary Outcome Measure Information:
Title
Delta Heart Rate (beat per minute)
Description
To compare the variation of heart rate after tetanic stimulation under general anesthesia based on propofol versus sevoflurane
Time Frame
From 1 minute before to 3 minutes after tetanic stimulation for each patient
Title
Delta Mean Arterial Blood Pressure (unit: mmHg)
Description
To compare the variation of mean arterial blood pressure (MABP) after tetanic stimulation under general anesthesia based on propofol versus sevoflurane
Time Frame
From 1 minute before to 3 minutes after tetanic stimulation for each patient
Title
Delta BIS (no unit for BIS index)
Description
To compare the variation of bispectral index (BIS) after tetanic stimulation under general anesthesia based on propofol versus sevoflurane
Time Frame
From 1 minute before to 3 minutes after tetanic stimulation for each patient
Title
Peak value of NOL (no unit)
Description
To compare the peak value of NOL after tetanic stimulation under general anesthesia based on propofol versus sevoflurane
Time Frame
From 1 minute before to 3 minutes after tetanic stimulation for each patient
Title
Peak value of Heart Rate (unit: beat per minute)
Description
To compare the peak value of heart rate after tetanic stimulation under general anesthesia based on propofol versus sevoflurane
Time Frame
From 1 minute before to 3 minutes after tetanic stimulation for each patient
Title
Peak value of Mean Arterial Blood Pressure (unit: mmHg)
Description
To compare the peak value of mean arterial blood pressure (MABP) after tetanic stimulation under general anesthesia based on propofol versus sevoflurane
Time Frame
From 1 minute before to 3 minutes after tetanic stimulation for each patient
Title
Peak value of BIS (no unit)
Description
To compare the peak value of bispectral index (BIS) after tetanic stimulation under general anesthesia based on propofol versus sevoflurane
Time Frame
From 1 minute before to 3 minutes after tetanic stimulation for each patient
Title
Area Under the Curve for NOL for Propofol Versus Sevoflurane (no unit)
Description
To compare the area under the curve between propofol and sevoflurane between the beginning of stimulation and 3 minutes after stimulation
Time Frame
From T0 (start stimulation) to 3 minutes after tetanic stimulation for each patient
Title
Area Under the Curve for Heart Rate for Propofol Versus Sevoflurane (no unit)
Description
To compare the area under the curve between propofol and sevoflurane between the beginning of stimulation and 3 minutes after stimulation
Time Frame
From T0 (start stimulation) to 3 minutes after tetanic stimulation for each patient
Title
Area Under the Curve for Mean Arterial Blood Pressure for Propofol Versus Sevoflurane (no unit)
Description
To compare the area under the curve between propofol and sevoflurane between the beginning of stimulation and 3 minutes after stimulation
Time Frame
From T0 (start stimulation) to 3 minutes after tetanic stimulation for each patient
Title
Area Under the Curve for BIS for Propofol Versus Sevoflurane (no unit)
Description
To compare the area under the curve between propofol and sevoflurane between the beginning of stimulation and 3 minutes after stimulation
Time Frame
From T0 (start stimulation) to 3 minutes after tetanic stimulation for each patient
Title
Total Dose of Remifentanil (unit: mcg)
Description
Total dose of remifentanil in mcg from induction of anesthesia until tracheal extubation
Time Frame
Intraoperative
Title
Total Dose of Propofol (unit: mg)
Description
Total dose of propofol in mg from induction of anesthesia until tracheal extubation in Propofol group
Time Frame
Intraoperative
Title
Total Dose of Sevoflurane (unit: mL)
Description
Total dose of sevoflurane in mL from induction of anesthesia until tracheal extubation in Sevoflurane group
Time Frame
Intraoperative
Title
Total Dose of Hydromorphone in post-anesthesia care unit (PACU) (unit: mg)
Description
Total dose of hydromorphone in mg in post-anesthesia care unit
Time Frame
From entrance in post-anesthesia care unit until post-anesthesia care unit discharge, an average of 2 hours
Title
post-anesthesia care unit (PACU) Pain Scores at Rest (scale from 0 to 10)
Description
Pain scores on a scale from 0 to 10 at rest in post-anesthesia care unit
Time Frame
From entrance in post-anesthesia care unit until post-anesthesia care unit discharge, an average of 2 hours
Title
post-anesthesia care unit (PACU) Pain Scores during Cough (scale from 0 to 10)
Description
Pain scores on a scale from 0 to 10 during cough effort in post-anesthesia care unit
Time Frame
From entrance in post-anesthesia care unit until post-anesthesia care unit discharge, an average of 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA status I, II or III Age 18 years or older Elective surgery under general anesthesia. Good understanding of English or French language Non-inclusion Criteria Ongoing Coronary artery disease Patients with non-regular sinus cardiac rhythm, implanted pacemakers, prescribed antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists and antiarrhythmic agents Emergent surgery Pregnancy/lactation Preoperative hemodynamic disturbance Central nervous system disorder (neurologic/head trauma/uncontrolled epileptic seizures) Patient refusal Drug or alcohol abuse within the last 6 months Chronic use of psychoactive drugs Pre-operative chronic opioid use or chronic pain, equivalent to oxycodone 20mg per oral, per day for more than 6 weeks History of psychiatric diseases or psychological problems Allergy or intolerance to any of the study drugs Exclusion Criteria: Unexpected difficult airway requesting excessive, possibly painful airway manipulations. Intraoperative unexpected complications requiring strong hemodynamic support (transfusions, vasopressors, inotropes)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Richebé
Phone
(514) 252-3400
Ext
4620
Email
philipperichebe@live.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nadia Godin
Phone
514-252-3400
Ext
3193
Email
ngodin.hmr@ssss.gouv.qc.ca
Facility Information:
Facility Name
CIUSSS de l'Est de l'Ile de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Richebé, MD, PhD
Phone
5147436558
Email
philippe.richebe@umontreal.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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NOL Index to Compare the Intraoperative Analgesic Effect of Propofol Versus Sevoflurane

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