Low and Moderete Flow Anaesthesia on Haemodynamics

NCT06871371 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: LFATUGCE
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemodynamics Instability; Arrhythmias Cardiac; Cerebral Oxygenation

Keywords

Low-Medium Flow Anesthesia, Hemodynamics, Oxygenation

Outcome Measures

Primary Outcomes (1)

• the effects of low-flow anesthesia on hemodynamic stability

  The primary objective was to detect the adverse effects of low-flow anesthesia on hemodynamic stability and arrhythmia risk

  in 2 months

Secondary Outcomes (1)

• the cerebral oxygenation

  in 2 months

Study Arms (2)

low flow anesthesia

ACTIVE COMPARATOR

Maintenance of anaesthesia with low-flow anaesthesia

Device: Sevoflurane (Volatile Anesthetic); Device: low- medium flow anesthetic machine

Medium Flow Anesthesia

ACTIVE COMPARATOR

Maintenance of anaesthesia with medium-flow anaesthesia

Device: Sevoflurane (Volatile Anesthetic); Device: low- medium flow anesthetic machine

Interventions

Sevoflurane (Volatile Anesthetic) DEVICE

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.

Medium Flow Anesthesia; low flow anesthesia

low- medium flow anesthetic machine DEVICE

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.

Medium Flow Anesthesia; low flow anesthesia

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye Education and research hospital

Istanbul, 34111, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• SENAY GOKSU, MD

  UMRANIYE E R HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

senay goksu, specialist doctor

CONTACT

+905337144852; senaytomruk@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: March 11, 2025
• Study Start: March 15, 2025
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

TU (1)