Evaluation of the Sevoflurane Consumption During General Anesthesia When Using the MemsorbTM Membrane

NCT04539405 | Completed

• 1 other identifier: 2020-2083
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims at determining whether replacing the classical chemical absorber Dräegersorb 800+ on Dräeger Perseus A500 machines (Dräeger, Lübeck, Germany) by the new membrane technology-based product (Memsorb™, DMF Medical Inc., Halifax, NS, Canada) with the help of high-quality monitoring (BIS and NOL) and high-end ventilators (Dräeger Perseus A500 machines; Dräeger, Lübeck, Germany) that allow minimal fresh gas flow, will significantly decrease the use of sevoflurane and its related atmospheric pollution.

Conditions

Laparoscopic General, Gynecological and Urologic Surgeries

Keywords

Sevoflurane; General anesthesia; Memsorb membrane

Outcome Measures

Primary Outcomes (1)

• To show a significant decrease of at least 25% of the sevoflurane consumption

  To compare the total sevoflurane consumption when using MemsorbTM versus DrägersorbTM. This will be expressed in mL.kg-1.h-1 of surgery and the primary objective will focus on H1 of surgery, H1 starting at the time of incision (T0).

  Intraoperative

Secondary Outcomes (4)

• To evaluate sevoflurane consumption for each hour of surgery

  Intraoperative

• To evaluate the pollution induced by anesthesia at H1 of surgery and consequent hours

  Intraoperative

• To evaluate the levels of expired CO2

  Intraoperative

• To evaluate the global costs of sevoflurane consumption

  Intraoperative

Study Arms (2)

Memsorb

M for memsorbTM group with the minimal gas flow possible (sevoflurane administration at 0.2L.min-1) with the ventilator Draeger A-500 Perseus,

Device: To evaluate sevoflurane consumption when using Memsorb

Dräegersorb

D for DraegersorbTM group with gas flow at 2L.min-1 (classical sevoflurane administration) with the same ventilator Draeger A-500 Perseus.

Device: To evaluate sevoflurane consumption when using classical Dräegersorb

Interventions

To evaluate sevoflurane consumption when using Memsorb DEVICE

Sevoflurane administration at 0.2L.min-1 (minimal gas flow)

Memsorb

To evaluate sevoflurane consumption when using classical Dräegersorb DEVICE

Sevoflurane administration at 2L.min-1 (classical gas flow)

Dräegersorb

Eligibility Criteria

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

Study Population

Enrollment of 50 randomized adult patients undergoing general anesthesia for laparoscopic general, gynecological or urologic surgery. Type of surgery: laparoscopic general, gynecological and urologic surgery with general anesthesia that does not require additional regional anesthesia such as an epidural analgesia.

You may qualify if:

• ASA 1-3,
• Laparoscopic general, gynecological or urologic surgery requiring general anesthesia without additional regional anesthesia technique,
• Fully consented,
• BMI \< 40,
• Age \> 18.

You may not qualify if:

• Allergy or contra-indication to any drug used in the study protocol,
• History of unstable coronary artery disease,
• Serious cardiac arrhythmia (including atrial fibrillation),
• History of substance abuse in the last 2 months prior to surgery,
• Chronic use of psychotropic and/or opioid drugs (still existing within the last month prior to surgery,
• History of psychiatric diseases,
• History of refractory PONV in previous surgery,
• Allergy to any drug used in the study protocol,
• Non-scheduled surgery,
• Refusal of the patient for participation in the study.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• DMF Medical Incorporated: collaborator

Study Sites (1)

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

Montreal East, Quebec, H1T2M4, Canada

Location

Study Officials

• Philippe PR Richebe, MD, PhD

  CIUSSS Est de l'île de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor with Tenure, Director of Research, Department of Anesthesiology and Pain Medicine, University of Montreal (UDeM), Maisonneuve Rosemont Hospital, CEMTL

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: May 4, 2021
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

CA (1)