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HypovolemiaNCT06231472

Effect of Preoperative Fluid Therapy on Post-induction Hypotension

A study testing weight-based fluid therapy in people with Hypovolemia, run by Mustafa Burgac 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

Although preoperative dehydration is a known risk factor for post-induction hypotension, evidence regarding preemptive weight-based fluid therapy remains limited. This study aimed to assess whether preemptive weight-based fluid therapy during fasting reduces the risk of post-induction hypotension. Read more about this study

Who is it for?
Ages 18 to 80 years, women onlyHealthy volunteers can take part
Conditions the study is for
Hypovolemia
What is being tested?
weight-based fluid therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2022to 1 Nov 2023
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 80 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Gynaecological pelvic surgery planned for patients aged 18 years and over
  • Patients with an American Society of Anaesthetists score of 1-2-3

Who cannot join

  • Unstable haemodynamics (persistent hypotension preventing extubation at the end of surgery, arrhythmia, ejection fraction (EF) < 40%),
  • Valvular heart disease,
  • Cardiac pacing,
  • Obesity (BMI >35),
  • Chronic obstructive pulmonary disease (COPD),
  • Increased intrabdominal pressure,
Show all 10Show fewer
  • Open wound at the US site,
  • Preoperative severe hypertension (systolic blood pressure >180 mmHg, diastolic >110 mmHg),
  • Use of angiotensin II receptor blockers (ARB), angiotensin coverting enzyme inhibitor (ACE-I)
  • Refusal to participate in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Professor Doctor Süleyman Yalçın City Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Preemptive Weight-Based Fluid Therapy Reduces Post-Induction Hypotension in Gynecological Pelvic Surgery: A Randomized Controlled Trial Using IVC Ultrasonography

Although preoperative dehydration is a known risk factor for post-induction hypotension, evidence regarding preemptive weight-based fluid therapy remains limited. This study aimed to assess whether preemptive weight-based fluid therapy during fasting reduces the risk of post-induction hypotension.

This trial randomized 122 patients. After excluding 12 patients (10 for non-visualized IVC, 2 for vasoactive agents), 110 patients (55 per group) were analyzed. Group A received preemptive fluid therapy versus Group B's standard fasting. The primary objective of the study was to evaluate the efficacy of preemptive weight-based fluid therapy on the prevention of post-induction hypotension following general anesthesia (Mean blood pressure/MBP < 60 mmHg or ≥ 30% decrease from baseline). Secondary outcomes included ultrasonographic parameters (Inferior vena cava diameter/dIVC, collapsibility index/CI%) and hemodynamic indices (Perfusion index/PI, pleth variability index/PVI, pulse pressure variation/PPV). Statistical analyses included receiver operating characteristic (ROC) curves and logistic regression.

Read the detailed description

This prospective, randomized, controlled study was approved by the Ministry of Health, Istanbul Medeniyet University, Göztepe Training and Research Hospital Clinical Research Ethics Committee (approval number 2022/0263, dated 27 April 2022) and was registered in ClinicalTrials.gov (NCT 06231472). The study was conducted by the principles outlined in the Declaration of Helsinki. Written and verbal informed consent was obtained from all participants.

This study was conducted between May 2022 and November 2023. A total of 122 female patients aged 18 years and older, scheduled for gynaecological pelvic surgery with an American Society of Anaesthesiologists (ASA) physical status score of I-III, were included in this study. Exclusion criteria included unstable haemodynamics (persistent hypotension preventing extubation, arrhythmia, ejection fraction/EF < 40%), valvular heart disease, cardiac pacing, obesity (Body mass index/BMI >35), chronic obstructive pulmonary disease (COPD), increased intra-abdominal pressure, open wounds at the ultrasound site, preoperative severe hypertension (systolic blood pressure/SBP > 180 mmHg, diastolic blood pressure/DBP > 110 mmHg), use of angiotensin II receptor blockers (ARB), angiotensin-converting enzyme inhibitors (ACE-I), and refusal to participate in the study.

Randomization was performed using the sealed envelope method. Envelopes were randomly numbered, and each patient selected an envelope to determine her group. Patients who selected an envelope with an even number were assigned to Group A (n = 55), while those who selected an envelope with an odd number were assigned to Group B (n = 55).

All patients underwent preoperative evaluation and medical optimization in the preoperative assessment clinic. A detailed explanation of the weight-based fluid therapy protocol was provided to the patients on the evening before surgery, and informed consent was obtained. Bowel preparation was performed by the gynecological surgery team, and oral intake was discontinued at midnight in accordance with standard institutional protocols.

Patients in Group A were managed according to a weight-based intravenous fluid protocol. The fluid was administered during the preoperative fasting period using a standardized formula: 4 mL/kg for the first 10 kg of body weight, 2 mL/kg for the next 10 kg, and 1 mL/kg for each remaining kilogram. Patients in Group B, who served as the control group, did not receive any preoperative fluid therapy. The total volume of fluid administered to Group A was calculated and documented upon the patient's arrival in the operating room.

Once in the operating theatre, standard monitoring was initiated, including 5-lead electrocardiography (ECG), pulse oximetry, and non-invasive blood pressure monitoring (Fabius GS Premium Drager Anesthesia monitor). A Masimo Rainbow (Adult/Neonatal Pulse CO-Oximeter Adhesive sensor) probe was placed on the left index finger for the measurement of PI and PVI.

Preoperative US assessment of the IVC was performed while the patient was spontaneously breathing in the supine position for at least 5 minutes before induction [14]. The IVC was visualized using a low-frequency convex probe (CA1-7AD Samsung probe) under a subcostal approach with the US (Samsung Medison H60 system). The maximum (IVC max) and minimum (IVC min) diameters of the IVC were measured during the respiratory cycle, and the CI (%) was calculated using the formula:

CI (%) = (dIVCexp-dIVCinsp) / dIVCexp ×100 Where dIVC_exp is the expiratory diameter, and dIVC_insp is the inspiratory diameter of the IVC.

For anesthesia induction, 1 mg/kg midazolam and 1 µg/kg fentanyl were administered intravenously for sedation. Induction agents included 2 mg/kg propofol and 0.6 mg/kg rocuronium bromide. Anesthesia maintenance was achieved using a sevoflurane/oxygen/air mixture with a minimum alveolar concentration (MAC) of 0.8-1.0, and remifentanil was infused at 0.05-1 µg/kg/min as an analgesic. Ventilation settings included a tidal volume of 8 ml/kg, a frequency of 12-16 breaths/min, and positive end-expiratory pressure (PEEP) of 5 cm/H2O.

After induction, an intravenous cannula was inserted into the right radial artery under aseptic conditions for invasive blood pressure monitoring. PPV was recorded post-induction. Non-invasive measurements of heart rate (HR), SBP, MBP, PI, PVI, and PPV were recorded every 10 minutes during the intraoperative period.

Hypotension was defined as an MBP < 60 mmHg or a decrease of 30% or more from baseline. Patients who developed hypotension (Group H) were treated with a 3 ml/kg bolus of infused fluid, and IV 5 mg ephedrine was administered if haemodynamics did not improve. Fluid replacement was provided according to the surgical fluid losses and diuresis during the intraoperative period.

Anaesthesia was discontinued at the end of surgery. Neuromuscular blockade was reversed using IV sugammadex. Patients who met extubation criteria were transferred to the recovery room and later discharged to the ward after achieving a Modified Aldrete score of 12.

The primary outcome of this study was to compare the incidence of hypotension following anaesthesia induction between two groups of patients undergoing elective pelvic gynecological surgery with mechanical bowel preparation: patients receiving prophylactic weight-based fluid therapy (Group A) and those who did not (Group B). Secondary outcomes included the assessment of the predictive efficacy of dIVC, CI (%), PI, PVI, and PPV parameters for hypotension in this patient population.

Conditions
Hypovolemia
Being tested
weight-based fluid therapy
Keywords
Post-induction hypotension, Preemptive fluid therapy
Medical subject headings
Hypovolemia

What participants receive

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

  • weight-based fluid therapyOther

    Group A received weight-based fluid therapy throughout the preoperative fasting period, whereas Group B did not receive any preoperative treatment.

Study groups in NCT06231472
Study groupRoleWhat they receive
Group A with preoperative weight-based fluid therapyOtherGroup A patients received fluid infusion calculated according to hourly weight before surgery.
Receives: Other: weight-based fluid therapy
Group B without preoperative weight-based fluid therapyNo interventionNo intervention was made to patients in group B.

What is being measured

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

  1. The primary outcome was a comparison of the incidence of post-induction hypotension between the two groups.

    All patients were thoroughly evaluated and medically optimised through the preoperative preparation outpatient clinic. The procedure for intra venous (IV) fluid infusion calculated according to preoperative weight was explained to the patient on the night of surgery and consent was obtained. Bowel cleansing procedure was performed by the gynaecological surgeon. Oral nutrition was discontinued at midnight, adhering to the routine practice of the gynaecology clinic. In Group A patients, maintenance fluid infusion calculated according to weight was started IV. The maintenance fluid calculated according to weight was infused hourly during the fasting period according to the method of 4 mL/st for the first 10 kg, 2 mL/st for the second 10 kg and 1 mL/st for each remaining kg.

    Measured: perioperative/procedural

Secondary outcomes (4)
  1. Secondary outcomes included the effect of PI, and PVI (%) in predicting hypotension.

    Baseline measurements of PI and PVİ (%) were recorded before induction of general anaesthesia. PI, and PVI (%) measurements were recorded every 10 minute throughout the procedure. PVI (%) = [(PI max - PI min) / PI max] x 100 calculated with the formula. Measurements were recorded every 10 minutes throughout the procedure

    Measured: perioperative/procedural

  2. Secondary outcomes included the effect of dIVC mm in predicting hypotension.

    IVC ultrasonography was performed before induction. The IVC was visualised in M-mode using a subcostal approach from its junction with the right atrium on the paramedian long axis. Minimum and maximum inferior vena cava diameters (millimetres) due to respiratory cycle were measured in M-mode.

    Measured: perioperative/procedural

  3. Secondary outcomes included the effect of PPV in predicting hypotension.

    Baseline measurements of PPV were recorded after induction of general anaesthesia. PPV measurements were recorded every 10 minute throughout the procedure. PPV= (PPmaks-PPmin)/PPort. x 100 calculated with the formula. Measurements were recorded every 10 minutes throughout the procedure

    Measured: perioperative/procedural

  4. Secondary outcomes included the effect of CI (%) in predicting hypotension.

    Minimum and maximum inferior vena cava diameters (millimetres) due to respiratory cycle were measured in M-mode. The inferior vena cava collapsibility index (IVC-CI)= (dIVC expiration-dIVC inspiration) × 100/dIVCexpiration was calculated using the formula and recorded as a percentage. Measurements were recorded every 10 min throughout the procedure

    Measured: perioperative/procedural

Timeline

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

  1. First posted30 Jan 2024
  2. Study start1 May 2022
  3. Primary completion1 Nov 2023
  4. Study completion1 Nov 2023

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
In the preoperative period, two groups were created: patients who received weight-based fluid therapy and patients who did not receive weight-based fluid therapy.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06231472
Sponsor's protocol ID
2022/0263
Status last verified
Dec 2025
First submitted
22 Dec 2023
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Participants' personal information will not be shared. Only the data and results used during the Study will be disclosed.

Questions about this trial

What is this clinical trial studying?

A study testing weight-based fluid therapy in people with Hypovolemia, run by Mustafa Burgac 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 2 inclusion and 10 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 19 Dec 2025. 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?

The primary outcome was a comparison of the incidence of post-induction hypotension between the two groups. (time frame: perioperative/procedural). 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 19 Dec 2025.

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