The Effect of Minimal Flow Sevoflurane Anesthesia

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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia Awareness; Anesthesia; Functional
• Intervention / Treatment: Drug: Sevoflurane inhalant product

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul
    • Şi̇şli̇, Istanbul, Turkey, 34736
      • Nebia Peker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	from the beginning to the end of anesthesia
CHANGE IN PaCO2	The partial pressure of carbon dioxide is the measure of carbon dioxide within arterial blood.	from the beginning to the end of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
volatile agent consumption amount	the total amount of volatile agent (sevoflurane) consumed at the end of the surgery	from the beginning to the end of anesthesia

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CHANGE IN HR	Heart rate per minute	from the beginning to the end of anesthesia
CHANGE IN MAP	Mean arterial pressure	from the beginning to the end of anesthesia

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Study Chair: Nurcan Coşkun, Sisli Hamidiye Etfal Training and Research Hospital; Study Chair: Serkan İslamoğlu, Sisli Hamidiye Etfal Training and Research Hospital

Publications and helpful links

General 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.
• 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.

Helpful Links

• Effects of Low-Flow Sevoflurane Anesthesia on Pulmonary Functions in Patients Undergoing Laparoscopic Abdominal Surgery
• The safety and efficacy of minimal-flow desflurane anesthesia during prolonged laparoscopic surgery

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): May 10, 2021

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 21, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 17, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: laparoscopic cholecystectomy; minimal flow anesthesia
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Intraoperative Awareness; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: 1019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No