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AnesthesiaNCT05414721

The Effects of Low Flow and Normal Flow Desflurane Anesthesia

A study testing Low flow desflurane anesthesia (Group D) in people with Anesthesia and Liver Functions, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aging is a physiological process. In the elderly, loss of functional reserve in all organ system, regression in anabolic processes and increase in catabolic processes are observed s (1). The number of geriatric patients is also increasing in our country. Read more about this study

Who is it for?
Ages 65 to 100 years
Conditions the study is for
Anesthesia, Liver Functions, Kidney Functions
What is being tested?
Low flow desflurane anesthesia (Group D)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
28 May 2021to 30 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 100 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients with an American Society of Anesthesiologists (ASA) status of class I-III,
  • Aged between 65 and 100 years,
  • Scheduled to undergo general anesthesia and, the surgeries that will take longer than 1 hour.

Who cannot join

  • ASA class ≥ III patients
  • Thorasic surgery
  • Neurosurgery
  • Cardiorespiratory disease,
  • Uncontrolled diabetes mellitus,
  • Coagulation disorders,
Show all 12Show fewer
  • Preoperative liver and renal dysfunction,
  • History of malignant hyperthermia,
  • Using nephrotoxic or hepatotoxic drugs,
  • Major bleeding (>1000 cc) is predicted in the operation,
  • Chronic alcoholism,
  • Patients with drug use or withdrawal symptoms

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Van Yüzüncü Yıl University, Faculty of Medicine

    Van, Tusba, 65080

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Low Flow and Normal Flow Desflurane Anesthesia on Postoperative Liver and Renal Functions and Serum Cystatin C Levels in Geriatric Patients: A Prospective Randomized Controlled Study

Aging is a physiological process. In the elderly, loss of functional reserve in all organ system, regression in anabolic processes and increase in catabolic processes are observed s (1). The number of geriatric patients is also increasing in our country. Technological developments in anesthesia and surgery technics show that we will provide medical services to more elderly patients over time(2). Cystatin C is excreted only by the kidney (7, 8). Serum cystatin C level is not affected by body muscle mass, age and gender. The half-life is short. Because of all these features, it is thought to be more sensitive than creatinine in evaluating kidney functions (8,9). In this study, it was aimed to compare the effects of low flow and normal flow desflurane anesthesia applied in geriatric patients on postoperative liver and kidney functions and serum cystatin C levels.

Read the detailed description

This prospective, randomized-controlled, observational study was approved by the ethics committee of Van Yuzuncu Yıl University (Date: 16.04.2021, Decision no: 05-27). The study was performed according to the World Medical Association's Declaration of Helsinki. All enrolled patients provided written informed consent.

In this prospective study; the patients were randomly divided into 2 groups according to the fresh gas flow applied. 'Group D' (n=30) was given to the low flow anesthesia group; the group in which normal flow anesthesia was administered was named 'Group N' (n=30).

Before anesthesia, automatic calibration of the anesthesia device (Primus, Drager) and leak tests were performed. In addition, the leak test was repeated manually for each patient. Alarm limits of the anesthesia device; The lower limit of inspired oxygen concentration (FiO2) was set to 30%, upper limit of inspired CO2 to 3%, and upper limit of end-tidal carbon dioxide (etCO2) to 45 mmHg.

The disconnection alarm was set to be 5 cmH2O lower than the peak pressure, the occlusion alarm was set to 30 cmH2O, the lower expiratory gas volume lower limit was set to be 500 mL below the desired minute volume (MV).

Soda lime (Sorbo-lime, Berkim, Turkey) was used as carbon dioxide absorbent. Soda lime was checked frequently for color and changed at appropriate times. Disposable anesthesia circuit and bacterial filter were used for each case.

Electrocardiography (ECG), peak heart rate (CTA), peripheral oxygen saturation (SpO2), non-invasive blood pressure and bispectral index (BIS) monitorisation (A-2000 Aspect medical systems, USA) were performed on all patien.

As a standard, vascular access was established with a 20-gauge (G) intraket from the dorsal of the hand or antecubital fossa in each patient and, a balanced electrolyte solution was infused of 8-10 ml/kg/hr.

All patients were preoxygenated with 100% O₂ for three minutes. For anesthesia induction, 0.03 mg/kg midazolam, 1-1.5 mcg/kg fentanyl, 2 mg/kg propofol and 0.6 mg/kg rocuronium were administered iv. Intubation was performed after adequate muscle relaxation was achieved. During mechanical ventilation; Tidal volume, PEEP, respiratory rate, etCO₂, and inspiration:expiration ratio were adjusted to be 7-10 ml/kg, 5 cmH2O, 12-14/min, 30-40 mmHg, 1:2 respectively.

Both groups were given a mixture of 50% O2 + 50% air + 6-7% desflurane in a 4 L/min fresh gas flow (FGF) until the minimum alveolar concentration (MAC) value was 1.

When the MAC value of desflurane was 1, FGF was reduced to 0.5 L/min (60% O2+40% dry air+8% desflurane) in Group D. In Group N, anesthesia was maintained by reducing FGF to 2 liters per minute (40% O2+60% air+6% desflurane). It was aimed to keep the MAC value between 0.9-1.1 and BIS values between 40-60 by titration of desflurane in all patients. Hemodynamic data, SpO2 and BIS values of the patients were recorded. It was recorded before induction, after induction, when switching to low/normal flow anesthesia, and during extubation.

Venous blood samples were obtained before induction, after surgery, and at the postoperative 24th hour to evaluate liver and kidney functions.

The SPSS 27.0 program was used to evaluate the data obtained in this study. In the descriptive statistics of the data, mean, standard deviation, median minimum, maximum, frequency and ratio values were used. The distribution of variables was measured with the Kolmogorov-Smirnov test. The mann-whitney u test was used in the analysis of quantitative independent data. Wilcoxon test was used in the analysis of dependent quantitative data. Chi-square test was used in the analysis of qualitative independent data, and the fischer test was used when the chi-square test conditions were not met. Statistical significance value was accepted as p<0.05 in all tests.

Being tested
Low flow desflurane anesthesia (Group D)
Keywords
Low flow desflurane anesthesia,, Liver functions, Kidney functions, Serum cystatin C levels, Geriatric patients.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low flow desflurane anesthesia (Group D)Drug

    Also called Normal flow desflurane anesthesia (Group N)

    When the MAC value of desflurane was 1, fresh gas flow was decreased to 0.5 L/min (60% O2+40% air). Hemodynamic parameters, SpO2 and BIS values were recorded after induction, at the beginning of low flow/normal flow anesthesia and every 5 minutes during surgery. The patients were observed in terms of side effects and complications during the operation and in the postoperative period. To research the liver and the kidney functions, blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.

Study groups in NCT05414721
Study groupRoleWhat they receive
Low flow desflurane anesthesia (Group D)Active comparatorAll patients were preoxygenated for three minutes. Midazolam 0.03 mg/kg, fentanyl 1.5 mcg/kg , propofol 2 mg/kg and rocuronium 0.6 mg/kg were administered iv for induction of anesthesia. After intubation all patients were mechanically ventilated with 50% O2+50% air + 6-7% desflurane in a 4 L/min fresh gas flow until the MAC value reached 1. When the MAC value of desflurane was 1, fresh gas flow was decreased to 0.5 L/min (60% O2+40% air) in Group D. Hemodynamic parameters, SpO2 and BIS values were recorded after induction, at the beginning of low flow/normal flow anesthesia and every 5 minutes during surgery. The patients were observed in terms of side effects and complications during the operation and in the postoperative period. To research the liver and the kidney functions, blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.
Receives: Drug: Low flow desflurane anesthesia (Group D)
Normal flow desflurane anesthesia (Group N)No interventionAll patients were preoxygenated for three minutes. Midazolam 0.03 mg/kg, fentanyl 1.5 mcg/kg , propofol 2 mg/kg and rocuronium 0.6 mg/kg were administered iv for induction of anesthesia. After intubation all patients were mechanically ventilated with 50% O2+50% air + 6-7% desflurane in a 4 L/min fresh gas flow until the MAC value reached 1. When the MAC value of desflurane was 1, fresh gas flow was decreased to 2 L/min (40% O2+60% air) in Group N. Hemodynamic parameters, SpO2 and BIS values were recorded after induction, at the beginning of low flow/normal flow anesthesia and every 5 minutes during surgery. The patients were observed in terms of side effects and complications during the operation and in the postoperative period. To research the liver and the kidney functions, blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alanin Aminotransferaz (ALT)

    To research the serum alanin Aminotransferaz (ALT) , blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.

    Measured: 24 hours

  2. Aspartat Aminotransferaz (AST)

    To research the serum Aspartat Aminotransferaz (AST) , blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.

    Measured: 24 hours

  3. Serum creatinine

    To research the serum creatinine , blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.

    Measured: 24 hours

  4. Serum cystatin C

    To research the Serum cystatin C , blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.

    Measured: 24 hours

  5. Blood urea nitrogen (BUN)

    To research the Blood urea nitrogen (BUN) , blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.

    Measured: 24 hours

Secondary outcomes (8)
  1. Heart rate (HR)

    HR were recorded before anesthesia induction and during surgery.

    Measured: 6 hours

  2. Systolic blood pressure (SBP)

    SBP were recorded before anesthesia induction and during surgery.

    Measured: 6 hours

  3. Diastolic blood pressure (DBP)

    DBP were recorded before anesthesia induction and during surgery.

    Measured: 6 hours

  4. Mean blood pressure (MBP)

    MBP were recorded before anesthesia induction and during surgery.

    Measured: 6 hours

  5. Drug allergies

    The patients were observed in terms of drug allergies, during the operation and in the postoperative period.

    Measured: 24 hours

  6. Nausea-vomiting

    The patients were observed in terms of nausea-vomiting during the operation and in the postoperative period.

    Measured: 24 hours

  7. Shivering and agitation

    The patients were observed in terms of shivering and agitation during the operation and in the postoperative period.

    Measured: 24 hours

  8. İnsufficient depth of anesthesia

    The patients were monitored with BİS monitorization for complications such as nsufficient depth of anesthesia

    Measured: During surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2022
  2. Study start28 May 2021
  3. Primary completion28 Jan 2022
  4. Study completion30 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Sixty patients were included in the study. The patients were randomly divided into two groups as low flow anesthesia and normal flow anesthesia. All patients were preoxygenated. Midazolam, fentanyl, propofol and rocuronium were administered iv for induction of anesthesia. After intubation all patients were mechanically ventilated with 50%O2+50% air+7% desflurane in a 4L/min fresh gas flow until the MAC value reached to 1. When the MAC value of desflurane was 1, the fresh gas flow was reduced to 0.5L/min (60%O2+40%air) in GroupD. In GroupN, the fresh gas flow was reduced to 2L/min (40%O2+60% air). The anesthesia was maintained in these fresh gas flows. HR, SBP, DBP, MBP, SpO2 and BIS values were recorded preanesthesia and during surgery. To research the liver and the kidney functions, blood samples were taken pre-induction, post-surgery, and at the postoperative 24th hour by venous route.
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05414721
Sponsor's protocol ID
2021/05-07
Status last verified
Jun 2022
First submitted
24 May 2022
Last updated
10 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol and statistical analysis plan will be share for other resarchers.

Publications

  • Horwitz M, Jakobsson JG. Desflurane and sevoflurane use during low- and minimal-flow anesthesia at fixed vaporizer settings. Minerva Anestesiol. 2016 Feb;82(2):180-5. Epub 2015 Jul 22.

    PubMed 26198766
  • Xie G, Jiang H. Clinical study of desflurane on low flow anesthesia compared with sevoflurane and enflurane. Chin Med J (Engl). 1997 Sep;110(9):707-10.

    PubMed 9642331
  • Baum JA, Aitkenhead AR. Low-flow anaesthesia. Anaesthesia. 1995 Oct;50 Suppl:37-44. doi: 10.1111/j.1365-2044.1995.tb06189.x.

    PubMed 7485917

Questions about this trial

What is this clinical trial studying?

A study testing Low flow desflurane anesthesia (Group D) in people with Anesthesia and Liver Functions, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alanin Aminotransferaz (ALT) (time frame: 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05414721, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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