Low and Moderete Flow Anaesthesia on Haemodynamics

March 6, 2025 updated by: Senay Goksu, Umraniye Education and Research Hospital

The Comparison of the Effects of Low and Medium Flow Anesthesia on Haemodynamics, Arrhytmia Risk and Cerebral Oxygenation in Laparoscopic Cholecystomy Cases

The study topic investigates the potential advantages of low-flow anesthesia in terms of physiological protection and resource saving.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study aims to compare the effects of low and normal flow sevoflurane anesthesia on the frontal QRS-T angle and cerebral oxygenation in laparoscopic cholecystectomy surgery. The primary objective was to evaluate the effects of low-flow anesthesia on hemodynamic stability and arrhythmia risk; the secondary objective was to compare the total sevoflurane consumption in both methods.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey, 34111
        • Umraniye Education and Research Hospital

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
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • being ASA1-2 status
  • between the ages of 18-70
  • who are planned for laparoscopic cholecystectomy

Exclusion Criteria:

  • Patients who refuse to give informed consent
  • Pregnant and breastfeeding patients
  • Morbidly obese patients (Body mass index over 40)
  • Patients with uncontrolled diabetes mellitus, with serious cardiovascular, pulmonary, renal, hepatic disease, obstructive sleep apnea, with electrolyte imbalance- Those with a history of alcohol or drug abuse, with perioperative hemodynamic instability
  • Patients using drugs known to prolong myocardial repolarization
  • inability to increase SPO2 above 95 despite necessary intervention

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: low flow anesthesia
Maintenance of anaesthesia with low-flow anaesthesia
Device: Sevoflurane (Volatile Anesthetic)
Both groups will be given sevoflurane and one group will be given low current anesthesia and the other group will be given medium flow anesthesia.
Device: low- medium flow anesthetic machine
The study aims to compare the effects of low and normal flow sevoflurane anesthesia on the frontal QRS-T angle and cerebral oxygenation in laparoscopic cholecystectomy surgery.
Active Comparator: Medium Flow Anesthesia
Maintenance of anaesthesia with medium-flow anaesthesia
Device: Sevoflurane (Volatile Anesthetic)
Both groups will be given sevoflurane and one group will be given low current anesthesia and the other group will be given medium flow anesthesia.
Device: low- medium flow anesthetic machine
The study aims to compare the effects of low and normal flow sevoflurane anesthesia on the frontal QRS-T angle and cerebral oxygenation in laparoscopic cholecystectomy surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effects of low-flow anesthesia on hemodynamic stability
Time Frame: in 2 months
The primary objective was to detect the adverse effects of low-flow anesthesia on hemodynamic stability and arrhythmia risk
in 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the cerebral oxygenation
Time Frame: in 2 months
The primary objective was to detect the adverse effects of low-flow anesthesia on cerebral oxygenation
in 2 months

Collaborators and Investigators

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

Sponsor

Umraniye Education and Research Hospital

Investigators

  • Principal Investigator: SENAY GOKSU, MD, UMRANIYE E R HOSPITAL

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 (Estimated)

March 15, 2025

Primary Completion (Estimated)

April 15, 2025

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

January 26, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LFATUGCE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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