The Effect of Minimal Flow Sevoflurane Anesthesia

Anesthesia; Functional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04813952
• Other study ID #: 1019
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: May 10, 2021

Study information

• Verified date: July 2021
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 10, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Awareness
• Anesthesia; Functional
• Intraoperative Awareness

Intervention

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.

Locations

Country	Name	City	State
Turkey	Nebia Peker	Si?sli?	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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 2 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CHANGE IN HR	Heart rate per minute	from the beginning to the end of anesthesia
Other	CHANGE IN MAP	Mean arterial pressure	from the beginning to the end of anesthesia
Primary	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
Primary	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	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

External 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