NCT04813952

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

March 10, 2021

Last Update Submit

July 17, 2021

Conditions

Anesthesia; FunctionalAnesthesia Awareness

Keywords

minimal flow anesthesialaparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • volatile agent consumption amount

    from the beginning to the end of anesthesia

Other Outcomes (2)

  • CHANGE IN HR

    from the beginning to the end of anesthesia

  • CHANGE IN MAP

    from the beginning to the end of anesthesia

Study Arms (2)

Group M

ACTIVE COMPARATOR

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

Group H

ACTIVE COMPARATOR

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

Interventions

Sevoflurane inhalant productDRUG

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.

Also known as: Sevorane
Group HGroup M

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA (American Society of Anesthesiologists) class I-II
  • The operation time between 60-180 minutes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nebia Peker

Şişli, Istanbul, 34736, Turkey (Türkiye)

Location

Related 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 2016 Jun 20.

    PMID: 27413741RESULT

  • 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.

    PMID: 23277809RESULT

Related Links

MeSH Terms

Conditions

Intraoperative Awareness

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Intraoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Nurcan Coşkun

    Sisli Hamidiye Etfal Training and Research Hospital

    STUDY CHAIR

  • Serkan İslamoğlu

    Sisli Hamidiye Etfal Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: they will 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 24, 2021

Study Start

February 15, 2021

Primary Completion

April 30, 2021

Study Completion

May 10, 2021

Last Updated

July 20, 2021

Record last verified: 2021-07

Locations

TU(1)