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NCT Number: NCT04813952

The Effect of Minimal Flow Sevoflurane Anesthesia

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

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Key information

Conditions

Anesthesia; Functional Anesthesia Awareness Intraoperative Awareness Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nebia Peker

Şişli, Istanbul, 34736, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Sevoflurane inhalant product

Drug

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.

Other names: Sevorane

Primary outcomes

  1. CHANGE IN P/F

    Time frame: from the beginning to the end of anesthesia

    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

  2. CHANGE IN PaCO2

    Time frame: from the beginning to the end of anesthesia

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

Secondary outcomes

  1. volatile agent consumption amount

    Time frame: from the beginning to the end of anesthesia

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

Other outcomes

  1. CHANGE IN HR

    Time frame: from the beginning to the end of anesthesia

    Heart rate per minute

  2. CHANGE IN MAP

    Time frame: from the beginning to the end of anesthesia

    Mean arterial pressure

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

The Effect of Minimal Flow Sevoflurane Anesthesia on Blood Gas Analysis and Hemodynamic Parameters in Laparoscopic Cholecystectomies, a Randomised Controlled Trial.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 24, 2021
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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