CompletedNot Applicable

Effect of Preoperative Fluid Therapy on Post-induction Hypotension

Turkey (Türkiye)110 participantsStarted 2022-05-01

Plain-language 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. 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.

Who can participate

Age range

18 Years – 80 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Gynaecological pelvic surgery planned for patients aged 18 years and over * Patients with an American Society of Anaesthetists score of 1-2-3 Exclusion Criteria: * 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, * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: perioperative/procedural

Trial details

NCT IDNCT06231472

SponsorMustafa Burgac

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-01

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