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Anesthesia, GeneralWASH-PRAMNCT07894393

Haemodynamic Effects of Four Sevoflurane Wash-In Strategies After Tracheal Intubation

A study testing Low-flow high-concentration wash-in (0.5 L/min, 8% sevoflurane), Low-flow wash-in (1 L/min, 4% sevoflurane) and Moderate-flow wash-in (2 L/min, 4% sevoflurane) in people with Anesthesia, General and Hypotension, run by Ataturk 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

The goal of this clinical trial is to compare how four different ways of starting sevoflurane anaesthesia (the "wash-in" phase) affect the heart and circulation during the first 10 minutes after endotracheal intubation in adults undergoing elective major urological surgery. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Anesthesia, General, Hypotension
What is being tested?
Low-flow high-concentration wash-in (0.5 L/min, 8% sevoflurane), Low-flow wash-in (1 L/min, 4% sevoflurane) and Moderate-flow wash-in (2 L/min, 4% sevoflurane)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Jan 2025to 30 Jan 2026
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-70 years
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Scheduled for elective major urological surgery under general anaesthesia with endotracheal intubation
  • Negative passive leg-raising test (mean arterial pressure increase of 10% or less during 45-degree passive leg raising)
  • Successful radial artery cannulation with an acceptable square-wave (fast-flush) test
  • Written informed consent

Who cannot join

  • ASA physical status III-IV
  • Cardiac arrhythmia
  • Valvular heart disease
  • Uncontrolled diabetes mellitus
  • Positive passive leg-raising test persisting after up to 600 mL crystalloid
  • Failed radial artery cannulation
  • Refusal to participate
  • More than two tracheal intubation attempts

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Atatürk University

    Erzurum, 25240

Other trials in Turkey (Türkiye)

About this study

Official title: Haemodynamic Effects of Four Sevoflurane Wash-In Strategies After Tracheal Intubation Assessed by the Pressure Recording Analytical Method: A Randomised Controlled Trial

The goal of this clinical trial is to compare how four different ways of starting sevoflurane anaesthesia (the "wash-in" phase) affect the heart and circulation during the first 10 minutes after endotracheal intubation in adults undergoing elective major urological surgery. The main question it aims to answer is whether the wash-in strategy affects cardiac index 10 minutes after intubation. Researchers also compared other haemodynamic variables, the time needed to reach the target anaesthetic concentration (0.8 MAC), sevoflurane consumption, the need for ephedrine to treat low blood pressure, and depth of anaesthesia.

After a standard intravenous induction, participants were randomly assigned to one of four sevoflurane wash-in strategies: automated end-tidal-controlled delivery, or manual delivery with 0.5 L/min fresh gas flow and 8% sevoflurane, 1 L/min with 4% sevoflurane, or 2 L/min with 4% sevoflurane. Haemodynamic variables were measured continuously through a radial arterial line using the pressure recording analytical method (PRAM).

Read the detailed description

This prospective, randomised, single-centre, parallel-group trial was conducted in the Department of Anesthesiology and Reanimation, Atatürk University Faculty of Medicine (Erzurum, Türkiye). Adult ASA physical status I-II patients scheduled for elective major urological surgery were screened with a 45-degree passive leg-raising (PLR) test; patients with a mean arterial pressure (MAP) increase >10% received up to 600 mL saline in 200-mL boluses and were excluded if the response persisted. A radial arterial line was then placed, and eligible patients were allocated by the sealed-envelope method to one of four wash-in groups.

Anaesthesia was induced with propofol 2.5 mg/kg, fentanyl 1.5 mcg/kg and rocuronium 0.7 mg/kg, and the trachea was intubated when state entropy fell below 60. Sevoflurane was then delivered via an Aisys CS2 anaesthesia workstation (Datex-Ohmeda/GE HealthCare) according to the allocated strategy:

  • Group 1: end-tidal-controlled mode targeting 0.8 MAC, minimum fresh gas flow (FGF) 0.5 L/min
  • Group 2: FGF 0.5 L/min with 8% sevoflurane
  • Group 3: FGF 1 L/min with 4% sevoflurane
  • Group 4: FGF 2 L/min with 4% sevoflurane Once the workstation-displayed age-adjusted MAC reached 0.8, maintenance in all groups was switched to end-tidal control targeting 0.8 MAC with a minimum FGF of 0.5 L/min. Ventilation settings were standardised and patients remained supine with no surgical stimulation during the 10-minute observation period.

Haemodynamic variables (systolic, diastolic and mean arterial pressure, heart rate, cardiac index, stroke volume index, pulse pressure variation, cardiac cycle efficiency, maximum rate of arterial pressure rise [dP/dt], arterial elastance and cardiac power index) were obtained with the pressure recording analytical method (MostCare Up, Vygon) before induction (T0), 30 s after intubation (T1), when 0.8 MAC was reached (T2) and 10 min after intubation (T3). State entropy, wash-in duration, cumulative sevoflurane consumption and ephedrine use were recorded. Hypotension (MAP <65 mmHg or a decrease >30% from baseline) was treated with 10 mg intravenous ephedrine.

The sample size (96 patients; 115 planned allowing for attrition) was calculated from pilot data for cardiac index at T3 (effect size f = 0.44, alpha 0.05, power 95%).

Being tested
End-tidal-controlled sevoflurane wash-in, Low-flow high-concentration wash-in (0.5 L/min, 8% sevoflurane), Low-flow wash-in (1 L/min, 4% sevoflurane), Moderate-flow wash-in (2 L/min, 4% sevoflurane)
Keywords
Sevoflurane, Wash-in, Low-flow anesthesia, Fresh gas flow, End-tidal control, Pressure recording analytical method, Cardiac index, Stroke volume
Medical subject headings
Hypotension

What participants receive

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

  • End-tidal-controlled sevoflurane wash-inOther

    After endotracheal intubation, sevoflurane is delivered with the Aisys CS2 workstation in automated end-tidal control mode targeting 0.8 MAC (age-adjusted, workstation-displayed), with a minimum fresh gas flow of 0.5 L/min.

  • Low-flow high-concentration wash-in (0.5 L/min, 8% sevoflurane)Other

    After endotracheal intubation, sevoflurane wash-in is performed manually with a fresh gas flow of 0.5 L/min and a vaporiser setting of 8% until the workstation-displayed MAC reaches 0.8, after which maintenance is switched to end-tidal control targeting 0.8 MAC (minimum fresh gas flow 0.5 L/min).

  • Low-flow wash-in (1 L/min, 4% sevoflurane)Other

    After endotracheal intubation, sevoflurane wash-in is performed manually with a fresh gas flow of 1 L/min and a vaporiser setting of 4% until the workstation-displayed MAC reaches 0.8, after which maintenance is switched to end-tidal control targeting 0.8 MAC (minimum fresh gas flow 0.5 L/min).

  • Moderate-flow wash-in (2 L/min, 4% sevoflurane)Other

    After endotracheal intubation, sevoflurane wash-in is performed manually with a fresh gas flow of 2 L/min and a vaporiser setting of 4% until the workstation-displayed MAC reaches 0.8, after which maintenance is switched to end-tidal control targeting 0.8 MAC (minimum fresh gas flow 0.5 L/min).

Study groups in NCT07894393
Study groupRoleWhat they receive
Group 1: End-tidal-controlled wash-inActive comparatorSevoflurane wash-in in automated end-tidal control mode targeting 0.8 MAC with a minimum fresh gas flow of 0.5 L/min.
Receives: Other: End-tidal-controlled sevoflurane wash-in
Group 2: 0.5 L/min FGF with 8% sevofluraneActive comparatorLow-flow, high-concentration (overpressure) sevoflurane wash-in with a fresh gas flow of 0.5 L/min and a vaporiser setting of 8% until 0.8 MAC is reached.
Receives: Other: Low-flow high-concentration wash-in (0.5 L/min, 8% sevoflurane)
Group 3: 1 L/min FGF with 4% sevofluraneActive comparatorLow-flow sevoflurane wash-in with a fresh gas flow of 1 L/min and a vaporiser setting of 4% until 0.8 MAC is reached.
Receives: Other: Low-flow wash-in (1 L/min, 4% sevoflurane)
Group 4: 2 L/min FGF with 4% sevofluraneActive comparatorModerate-flow sevoflurane wash-in with a fresh gas flow of 2 L/min and a vaporiser setting of 4% until 0.8 MAC is reached.
Receives: Other: Moderate-flow wash-in (2 L/min, 4% sevoflurane)

What is being measured

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

  1. Cardiac index

    Cardiac index (L/min/m2) measured with the pressure recording analytical method (PRAM; MostCare Up) via a radial arterial line, compared between the four wash-in groups.

    Measured: 10 minutes after endotracheal intubation

Secondary outcomes (16)
  1. Systolic arterial pressure

    Systolic arterial pressure (mmHg) measured with the pressure recording analytical method (PRAM; MostCare Up) via a radial arterial line. At each time point, the highest value among five consecutive beats was recorded.

    Measured: Before induction (T0), 30 seconds after intubation (T1), when 0.8 MAC is reached (T2) and 10 minutes after intubation (T3)

  2. Diastolic arterial pressure

    Diastolic arterial pressure (mmHg) measured with the pressure recording analytical method (PRAM; MostCare Up) via a radial arterial line. At each time point, the highest value among five consecutive beats was recorded.

    Measured: Before induction (T0), 30 seconds after intubation (T1), when 0.8 MAC is reached (T2) and 10 minutes after intubation (T3)

  3. Mean arterial pressure

    Mean arterial pressure (mmHg) measured with the pressure recording analytical method (PRAM; MostCare Up) via a radial arterial line. At each time point, the highest value among five consecutive beats was recorded.

    Measured: Before induction (T0), 30 seconds after intubation (T1), when 0.8 MAC is reached (T2) and 10 minutes after intubation (T3)

  4. Heart rate

    Heart rate (beats/min) measured with the pressure recording analytical method (PRAM; MostCare Up) via a radial arterial line. At each time point, the highest value among five consecutive beats was recorded.

    Measured: Before induction (T0), 30 seconds after intubation (T1), when 0.8 MAC is reached (T2) and 10 minutes after intubation (T3)

  5. Cardiac index at other time points

    Cardiac index (L/min/m2) measured with the pressure recording analytical method (PRAM; MostCare Up) via a radial arterial line. At each time point, the highest value among five consecutive beats was recorded.

    Measured: Before induction (T0), 30 seconds after intubation (T1) and when 0.8 MAC is reached (T2)

  6. Stroke volume index

    Stroke volume index (mL/m2) measured with the pressure recording analytical method (PRAM; MostCare Up) via a radial arterial line. At each time point, the highest value among five consecutive beats was recorded.

    Measured: Before induction (T0), 30 seconds after intubation (T1), when 0.8 MAC is reached (T2) and 10 minutes after intubation (T3)

  7. Pulse pressure variation

    Pulse pressure variation (%) measured with the pressure recording analytical method (PRAM; MostCare Up) via a radial arterial line. At each time point, the highest value among five consecutive beats was recorded. Not assessed at T0 because patients were breathing spontaneously.

    Measured: 30 seconds after intubation (T1), when 0.8 MAC is reached (T2) and 10 minutes after intubation (T3)

  8. Cardiac cycle efficiency

    Cardiac cycle efficiency (unitless index, range -1 to +1) measured with the pressure recording analytical method (PRAM; MostCare Up) via a radial arterial line. At each time point, the highest value among five consecutive beats was recorded.

    Measured: Before induction (T0), 30 seconds after intubation (T1), when 0.8 MAC is reached (T2) and 10 minutes after intubation (T3)

  9. Maximum rate of arterial pressure rise (dP/dt)

    Maximum rate of rise of the radial arterial pressure, dP/dt (mmHg/ms) measured with the pressure recording analytical method (PRAM; MostCare Up) via a radial arterial line. At each time point, the highest value among five consecutive beats was recorded.

    Measured: Before induction (T0), 30 seconds after intubation (T1), when 0.8 MAC is reached (T2) and 10 minutes after intubation (T3)

  10. Arterial elastance

    Arterial elastance (mmHg/mL) measured with the pressure recording analytical method (PRAM; MostCare Up) via a radial arterial line. At each time point, the highest value among five consecutive beats was recorded.

    Measured: Before induction (T0), 30 seconds after intubation (T1), when 0.8 MAC is reached (T2) and 10 minutes after intubation (T3)

  11. Cardiac power index

    Cardiac power index (W/m2) measured with the pressure recording analytical method (PRAM; MostCare Up) via a radial arterial line. At each time point, the highest value among five consecutive beats was recorded.

    Measured: Before induction (T0), 30 seconds after intubation (T1), when 0.8 MAC is reached (T2) and 10 minutes after intubation (T3)

  12. Wash-in duration

    Time (seconds) from the start of sevoflurane delivery after intubation until the age-adjusted MAC displayed by the anaesthesia workstation reaches 0.8.

    Measured: From start of sevoflurane delivery until 0.8 MAC is reached (up to 10 minutes after intubation)

  13. Cumulative sevoflurane consumption

    Cumulative liquid sevoflurane consumption (mL) as reported numerically by the anaesthesia workstation.

    Measured: When 0.8 MAC is reached and 10 minutes after intubation

  14. Number of participants requiring ephedrine

    Number of participants who received at least one 10-mg intravenous bolus of ephedrine for hypotension, defined as mean arterial pressure <65 mmHg or a decrease >30% from baseline.

    Measured: From induction of anaesthesia to 10 minutes after intubation

  15. Time to first ephedrine administration

    Time (seconds) from induction of anaesthesia to the first intravenous ephedrine bolus given for hypotension (mean arterial pressure <65 mmHg or a decrease >30% from baseline).

    Measured: From induction of anaesthesia to 10 minutes after intubation

  16. State entropy

    State entropy (units on a scale, 0-91) measured with the GE Entropy module; lower values indicate deeper hypnosis.

    Measured: 30 seconds after intubation (T1), when 0.8 MAC is reached (T2) and 10 minutes after intubation (T3)

Timeline

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

  1. First posted26 Oct 2026
  2. Study start30 Jan 2025
  3. Primary completion30 Jan 2026
  4. Study completion30 Jan 2026

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Four-arm, parallel-group randomised trial comparing four sevoflurane wash-in strategies started immediately after endotracheal intubation.
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07894393
Sponsor's protocol ID
Low Flow-Haemodynamic
Other IDs
TTU-2025-16112
Acronym
WASH-PRAM
Status last verified
Oct 2026
First submitted
19 Oct 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Low-flow high-concentration wash-in (0.5 L/min, 8% sevoflurane), Low-flow wash-in (1 L/min, 4% sevoflurane) and Moderate-flow wash-in (2 L/min, 4% sevoflurane) in people with Anesthesia, General and Hypotension, run by Ataturk 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 6 inclusion and 8 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 26 Oct 2026. 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?

Cardiac index (time frame: 10 minutes after endotracheal intubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 26 Oct 2026.

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