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临床试验/NCT06231472
NCT06231472已完成不适用

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

Mustafa Burgac1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
1
主要终点
The primary outcome was a comparison of the incidence of post-induction hypotension between the two groups.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

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

时间窗: perioperative/procedural

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.

次要结局

  • 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)
  • 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)

研究者

发起方
Mustafa Burgac
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mustafa Burgac

chief researcher, Assistant doctor

Istanbul Medeniyet University

研究点 (1)

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