NCT06520943

Brief Summary

This study aims to compare the use of low fresh gas flow (1 L/min) desflurane anesthesia with minimum fresh gas flow (0.5 L/min) desflurane anesthesia in patients undergoing robotic-assisted abdominal surgery. The comparison will be based on hemodynamic and respiratory parameters. The secondary aim of our study is to compare the two different fresh gas flow methods in terms of inhalation agent consumption and soda lime consumption.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

July 9, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

July 9, 2024

Last Update Submit

July 23, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • inspiratory O2 concentration

    inspiratory O2 concentration is measured from anesthesia machine monitor

    from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)

  • partial oxygen pressure

    PO2 from blood gas analysis

    from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)

Secondary Outcomes (2)

  • desflurane consumption

    3th hour

  • changes in liver and kidney function tests from the preoperative values to 48 hours postoperative

    postoperative 1st day

Study Arms (2)

Group 1

After intubation, a fresh gas flow of 3 L/min will be applied for the first 20 minutes and then reduced to 0.5 L/min.

Other: blood gas analysis

Group 2

After intubation, a fresh gas flow of 3 L/min will be applied for the first 20 minutes and then reduced to 1 L/min.

Other: blood gas analysis

Interventions

1. Airway pressure (P plateau, Ppeak) values are taken from the anesthesia device data, 2. BIS (from routine BIS monitoring) 3. Temperature (routinely from pharyngeal temperature probe), 4. Oxygen saturation (routinely from the patient monitor) 5. End-tidal CO₂, 6. inspiratory O₂ concentration, 7. Inspiratory CO2 concentration, 8. inspiratory and expiratory desflurane concentrations, 9. tidal volume, 10. MAC is routinely obtained from anesthesia device data. 11. Blood Gas Analysis (COHgb, Ph, PO2, PCO2, SaO2, HCO3, Base deficit, glucose, lactate)

Group 1Group 2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing robotic-assisted abdominal surgery

You may qualify if:

  • Patients undergoing robotic-assisted abdominal surgery

You may not qualify if:

  • serious cardiac, respiratory, hepatic, renal, or mental disorders;
  • hearing problems;
  • anxiety, depression, or other psychiatric conditions;
  • patient's request to leave the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood gas analysis

MeSH Terms

Interventions

Blood Gas Analysis

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Study Officials

  • Betül Güven Aytaç

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Betül Güven Aytaç

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc. prof

Study Record Dates

First Submitted

July 9, 2024

First Posted

July 25, 2024

Study Start

July 15, 2024

Primary Completion

September 1, 2024

Study Completion

December 31, 2024

Last Updated

July 25, 2024

Record last verified: 2024-07

Locations