High Vs. Low Flow Sevoflurane Anesthesia in Pediatric Laparoscopic Surgery: Recovery, Hemodynamics, and Cost Comparison

January 21, 2025 updated by: Sibel Barış, Ondokuz Mayıs University

Evaluation of High and Low Flow Sevoflurane Anesthesia in Pediatric Patients Undergoing Laparoscopic Surgeries in Terms of Recovery, Hemodynamics, and Cost

The primary objective of our study is to compare the effects of different flow rates of the routinely used inhalation agent, sevoflurane, on postoperative recovery times in pediatric patients undergoing elective laparoscopic surgeries. Our secondary objectives are to evaluate the impact of different flow rates on hemodynamic parameters, ventilation parameters, and costs.

Study Overview

Status

Completed

Conditions

Detailed Description

Low-flow anesthesia is a technique in which at least 50% of the exhaled gas is returned to the system through rebreathing. When using modern rebreathing systems, low-flow anesthesia can be defined if the fresh gas flow rate is reduced below 2 L/min. This anesthesia method involves using an anesthesia system with rebreathing capabilities, where carbon dioxide is removed from the gas mixture exhaled by the patient, and then at least 50% of the fresh oxygen flow, along with volatile anesthetics sufficient to meet the body's metabolic requirements, is returned to the patient.

The application of low-flow anesthesia reduces the consumption of anesthetic gases, decreases the cost of anesthesia, minimizes contamination of the working environment and atmosphere with anesthetic gases, preserves the respiratory physiology of the patient, and minimizes heat and humidity loss by heating and humidifying the gases delivered to the patient, thereby better maintaining the physiology of the trachea and bronchial environments. The heating of gases is also beneficial for maintaining body temperature and preventing postoperative hypothermia. Additionally, due to the requirement for close monitoring, anesthesia safety is increased .

In pediatric patients, due to their different anatomical and physiological characteristics compared to adults, the application of low fresh gas flow anesthesia can be more challenging. This is especially the case when using uncuffed endotracheal tubes, where leaks may occur in the respiratory system, and the breathing circuits used may increase dead space. However, studies have shown that with appropriate techniques and adequate monitoring, these potential problems can be prevented, and low-flow anesthesia can be safely applied in children with close monitoring.

In our study, the investigators aim to compare the effects of different flow rates on postoperative recovery, hemodynamic factors, and costs in children, and to demonstrate that low-flow anesthesia can be applied as safely as high-flow anesthesia in pediatric patients. The investigators believe our study will contribute significantly to the literature on this topic.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey, 55200
        • 19 Mayis Üniversitesi Tip Fakültesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Pediatric patients undergoing laparoscopic surgery

Description

Inclusion criteria:

Patients with an American Society of Anesthesiologists (ASA) classification of I-II.

Elective laparoscopic surgeries expected to last longer than 30 minutes but shorter than 180 minutes

Exclusion Criteria:

Patients who are not candidates for laparoscopic surgery. Patients unsuitable for low-flow anesthesia due to inadequate monitoring conditions.

Patients whose relatives are unable to provide informed consent. Patients with an American Society of Anesthesiologists (ASA) classification higher than II.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Low flow
Low flow Anestesia
High Flow
High Flow Anestesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recovery times with Aldrete recovery score
Time Frame: 15/09/24-30/11/24
15/09/24-30/11/24

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of intraoperative hypothermia by esophageal temperature measurements
Time Frame: 15/09/24-30/11/24
15/09/24-30/11/24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

October 7, 2024

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • High/Low flow Anestesia

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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