Effect of Preoperative Fluid Therapy on Post-induction Hypotension

NCT06231472 | Completed

• 1 other identifier: 2022/0263
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypovolemia

Keywords

Post-induction hypotension, Preemptive fluid therapy

Outcome Measures

Primary Outcomes (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.

  perioperative/procedural

Secondary Outcomes (4)

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

  perioperative/procedural

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

  perioperative/procedural

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

  perioperative/procedural

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

  perioperative/procedural

Study Arms (2)

Group A with preoperative weight-based fluid therapy

OTHER

Group A patients received fluid infusion calculated according to hourly weight before surgery.

Other: weight-based fluid therapy

Group B without preoperative weight-based fluid therapy

NO INTERVENTION

No intervention was made to patients in group B.

Interventions

weight-based fluid therapy OTHER

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

Group A with preoperative weight-based fluid therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mustafa Burgac: lead

Study Sites (1)

Istanbul Professor Doctor Süleyman Yalçın City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• hasan koçoğlu

  clinic chief

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief researcher, Assistant doctor

Model Details: 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.

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 30, 2024
• Study Start: May 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)