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

NCT04567160 | Completed Phase 4

• 1 other identifier: 2021-2343
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Nociceptive Pain; Anesthesia

Keywords

NOL index

Outcome Measures

Primary Outcomes (1)

• 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

  From 1 minute before to 3 minutes after tetanic stimulation for each patient

Secondary Outcomes (17)

• Delta Heart Rate (beat per minute)

  From 1 minute before to 3 minutes after tetanic stimulation for each patient

• Delta Mean Arterial Blood Pressure (unit: mmHg)

  From 1 minute before to 3 minutes after tetanic stimulation for each patient

• Delta BIS (no unit for BIS index)

  From 1 minute before to 3 minutes after tetanic stimulation for each patient

• Peak value of NOL (no unit)

  From 1 minute before to 3 minutes after tetanic stimulation for each patient

• Peak value of Heart Rate (unit: beat per minute)

  From 1 minute before to 3 minutes after tetanic stimulation for each patient

Study Arms (2)

Propofol group

ACTIVE COMPARATOR

Induction and maintenance of general anesthesia using propofol

Drug: Propofol

Sevoflurane group

ACTIVE COMPARATOR

Induction and maintenance of general anesthesia using sevoflurane

Drug: Sevoflurane

Interventions

Propofol DRUG

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.

Propofol group

Sevoflurane DRUG

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.

Sevoflurane group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

CIUSSS de l'Est de l'Ile de Montreal

Montreal, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Nociceptive Pain

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD, DESAR, Chair of Research

Model Details: Randomized controlled parallel open label study

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 28, 2020
• Study Start: October 1, 2020
• Primary Completion: March 17, 2022
• Study Completion: March 17, 2022
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)