Clinical trial

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

Name

2021-2343

Description

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).

Trial arms

Trial start

2020-10-01

Estimated PCD

2022-03-17

Trial end

2022-03-17

Status

Completed

Phase

Early phase I

Treatment

Propofol

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.

Arms:

Propofol group

Sevoflurane

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.

Arms:

Sevoflurane group

Size

Primary endpoint

Delta NOL (no unit for the NOL index)

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

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled parallel open label study', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2023-12-21

1 organization

2 products

2 indications

Organization

CIUSSS de l'Est de l'Île de Montréal

Product

Indication

Indication

Product