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CompletedNCT04813952Updated Jul 20, 2021

The Effect of Minimal Flow Sevoflurane Anesthesia

An interventional study of Sevoflurane inhalant product in Anesthesia; Functional and Anesthesia Awareness, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-07-20.

Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Our aim is to investigate the effect of minimal flow anesthesia with sevoflurane on hemodynamics and arterial blood gas parameters in laparoscopic cholecystectomy operations.

Read the detailed description

Introduction: Low-flow anesthesia techniques have regained popularity in recent years with the development of low solubility volatile agents such as sevoflurane and desflurane, and modern anesthesia devices. Reducing the flow of fresh gas as much as possible will reduce the amount of volatile agent used, thus preventing air pollution, providing lower costs, and also preserving heat and moisture in the respiratory tract by using rebreathing systems. Laparoscopic surgery is superior to open surgical techniques due to its minimally invasive nature, less postoperative pain, less incidence of wound infections, shortening the hospitalization, and allowing patients to return to their normal lives sooner after the operation.

Our aim is to investigate the effect of minimal flow anesthesia with sevoflurane on hemodynamics and arterial blood gas parameters in laparoscopic cholecystectomy operations.

Material and Method: Seventy patients with ASA (American Society of Anesthesiologists) class I-II between the ages of 18-65 undergoing elective laparoscopic cholecystectomy were included in the study. After the patients were randomly selected by computer, they were divided into two equal groups as Group M (minimal flow anesthesia group) with fresh gas flow 0,5 L.min-1 and Group C (high flow anesthesia/ control group) with fresh gas flow 4 L.min-1. In both groups. Demographic data, duration of anesthesia, operation times, recovery times, hemodynamic parameters and arterial blood gas parameters of all patients were recorded. The patient data collected in both groups were compared statistically.

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Conditions studied

  • Anesthesia; Functional
  • Anesthesia Awareness

Keywords

  • minimal flow anesthesia
  • laparoscopic cholecystectomy
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In context

Intraoperative Awareness

51 studies on the registry are indexed under Intraoperative Awareness; 7 are open to participants now.

This study's enrollment of 70 is above the median of 60 across 25 interventional studies indexed under Intraoperative Awareness.

Browse Intraoperative Awareness studies →

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital is the lead sponsor of 110 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA (American Society of Anesthesiologists) class I-II
  • The operation time between 60-180 minutes

Exclusion criteria

Exclusion Criteria:

  • Severe cardiac disease
  • COPD (Chronic Obstructive Pulmonary Disease)
  • Severe liver and kidney disease,
  • Diabetes mellitus
  • Morbid obesity
  • Alcohol and/or drug addiction
  • Risk or history of malignant hyperthermia
  • Pregnancy and lactation
  • Emergency cases
  • Operation time less than 60 minutes and longer than 180 minutes
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    Group M

    Group M is minimal flow anesthesia group with fresh gas flow 0,5 L.min-1. Thirty five patients with ASA class I-II and between the ages of 18-65 undergoing elective laparoscopic cholecystectomy will be included. These patients were planned to be administered sevoflurane anesthesia with 0,5 L.min-1 flow under general anesthesia.

    Drug: Sevoflurane inhalant product

  • Active comparator
    Group H

    Group H is high flow anesthesia group with fresh gas flow 4 L.min-1. Thirty five patients with ASA class I-II and between the ages of 18-65 undergoing elective laparoscopic cholecystectomy will be included. These patients were planned to be administered sevoflurane anesthesia with 4 L.min-1 flow under general anesthesia.

    Drug: Sevoflurane inhalant product

Interventions

  • DrugSevoflurane inhalant product

    The sevoflurane dose differed in both groups in relation to the fresh gas flow. Since the fresh gas flow is less in group M, the concentration of sevoflurane consumed by the patient at the end of the case will be less.

    Also known as: Sevorane

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What researchers measure

Primary outcomes

  1. CHANGE IN P/F

    PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage). P/F ratio is a widely used clinical indicator of hypoxaemia

    Time frame: from the beginning to the end of anesthesia

  2. CHANGE IN PaCO2

    The partial pressure of carbon dioxide is the measure of carbon dioxide within arterial blood.

    Time frame: from the beginning to the end of anesthesia

Secondary outcomes

  1. volatile agent consumption amount

    the total amount of volatile agent (sevoflurane) consumed at the end of the surgery

    Time frame: from the beginning to the end of anesthesia

Other outcomes

  1. CHANGE IN HR

    Heart rate per minute

    Time frame: from the beginning to the end of anesthesia

  2. CHANGE IN MAP

    Mean arterial pressure

    Time frame: from the beginning to the end of anesthesia

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Study locations

1 site
  • Nebia Peker
    Şi̇şli̇, Istanbul 34736, Turkey
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References and documents

Publications

  • Doger C, Kahveci K, Ornek D, But A, Aksoy M, Gokcinar D, Katar D. Effects of Low-Flow Sevoflurane Anesthesia on Pulmonary Functions in Patients Undergoing Laparoscopic Abdominal Surgery. Biomed Res Int. 2016;2016:3068467. doi: 10.1155/2016/3068467. Epub 2016 Jun 20. PubMed 27413741 ↗
  • Park SY, Chung CJ, Jang JH, Bae JY, Choi SR. The safety and efficacy of minimal-flow desflurane anesthesia during prolonged laparoscopic surgery. Korean J Anesthesiol. 2012 Dec;63(6):498-503. doi: 10.4097/kjae.2012.63.6.498. Epub 2012 Dec 14. PubMed 23277809 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04813952
Lead sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Responsible party
Nebia Peker (medical doctor, Sisli Hamidiye Etfal Training and Research Hospital) — Principal investigator
First posted
Mar 24, 2021
Start date
Feb 15, 2021
Primary completion
Apr 30, 2021
Completion
May 10, 2021
Last update
Jul 20, 2021

Study contacts

Nurcan Coşkun
study chair · Sisli Hamidiye Etfal Training and Research Hospital
Serkan İslamoğlu
study chair · Sisli Hamidiye Etfal Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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