NCT06967948

Brief Summary

Volunteers above the age of 18 and below the age of 60 who agreed to participate in the study were not exposed to any interventional intervention other than those routinely applied to the patient during and after the administration of the clinical standard anesthesia protocol. The value indicating the brain's response to hypnotic substances, the vapor concentration in the lung alveoli and the minimum amount of anesthesia gas used will be recorded at certain times. The aim of the researchers in the study was to observe the effect of two different fresh gas flow rates on the amount and cost of waste gas released into the atmosphere.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 16, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 14, 2025

Last Update Submit

May 13, 2025

Conditions

Outcome Measures

Primary Outcomes (11)

  • Demographic data

    Demographic data such as age (years), height (cm), weight (kg) and gender (male/female) of the volunteer patients will be analyzed to see if they are similar for both study groups.

    preoperative

  • Duration of surgery

    It will be examined whether the duration of surgery (minutes) is similar for volunteer patients

    During the period of operation (2-4 hours)

  • Duration of anesthesia

    It will be examined whether the duration of anesthesia (minutes) is similar for volunteer patients

    During the period of operation (2-4 hours)

  • Heart rate

    We will examine whether there is a difference in heart rate (beats/minute) values recorded at 5-minute intervals in the first half hour and at 15-minute intervals thereafter in volunteer patients

    During the period of operation (2-4 hours)

  • Systolic blood pressure

    The volunteer patients will be examined for differences in systolic blood pressure (mmHg) values recorded at 5-minute intervals in the first half hour and at 15-minute intervals thereafter

    During the period of operation (2-4 hours)

  • Diastolic blood pressure

    The volunteer patients will be examined for differences in diastolic blood pressure (mmHg) values recorded at 5-minute intervals in the first half hour and at 15-minute intervals thereafter

    During the period of operation (2-4 hours)

  • Mean blood pressure

    The volunteer patients will be examined for differences in mean blood pressure (mmHg) values recorded at 5-minute intervals in the first half hour and at 15-minute intervals thereafter

    During the period of operation (2-4 hours)

  • Oxygen saturation

    We will examine whether there is a difference between the oxygen saturation (%) values measured at 5-minute intervals in the first half hour and then at 15-minute intervals in volunteer patients.

    During the period of operation (2-4 hours)

  • Total inhaled gas consumption

    Total inhaled gas consumption (milliliter) at the end of anesthesia will be examined whether it is similar for volunteer patients.

    During the period of operation (2-4 hours)

  • Minimum alveolar concentration (MAC)

    Minimum alveolar concentration (MAC) values are recorded at 1-minute intervals in the first 10 minutes at the onset of anesthesia, at 5-minute intervals between 10 minutes and half an hour, and at 15-minute intervals after half an hour and will be examined for differences between volunteers.

    During the period of operation (2-4 hours)

  • Bispectral index (BIS)

    Bispectral index (BIS) values are recorded at 1-minute intervals in the first 10 minutes at the onset of anesthesia, at 5-minute intervals between 10 minutes and half an hour, and at 15-minute intervals after half an hour and will be examined for differences between volunteers.

    During the period of operation (2-4 hours)

Study Arms (2)

1 lt/min

''Wash in period'' 1 lt/min fresh gas flow is used.

4 lt/min

''Wash in period'' 4 lt/min fresh gas flow is used.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Male or female Between 18-60 years of age ASA I-II risk group patients with general anesthesia Duration of surgery between 2 hours and 4 hours

You may qualify if:

  • ASA I-II risk group patients Duration of surgery between 2 hours and 4 hours, cases with general anesthesia

You may not qualify if:

  • Patient refusal to participate in the study
  • Under 18 years old BMI\>40
  • Patients receiving invasive mechanical ventilator support in the last 1 month
  • Patients who have received chemotherapy or radiotherapy in the last 2 months
  • Those with severe lung disease (COPD, asthma, pulmonary infection, bronchiectasis, previous need for non-invasive mechanical ventilation, oxygen therapy or steroid therapy for acute attack)
  • Known severe pulmonary hypertension
  • Smoke poisoning (carbon monoxide, cyanide poisoning)
  • Alcohol or acetone poisoning
  • Malignant hyperthermia
  • Intracranial tumor
  • Hemodynamic instability
  • Shock
  • Neuromuscular disease
  • Pathologies causing increased intracranial and intraocular pressure
  • Those with severe cardiac arrhythmias Those with -EF\<30
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Balıkesir University Health Practice and Research Hospital Operating Room

Balıkesir, Turkey (Türkiye)

RECRUITING

Balıkesir University Health Practice and Research Hospital

Balıkesir, Turkey (Türkiye)

RECRUITING

Balıkesir University Health Practice and Research Hospital

Balıkesir, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Serkan Uçkun, assistant professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

April 14, 2025

First Posted

May 13, 2025

Study Start

April 10, 2025

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

May 16, 2025

Record last verified: 2025-04

Locations