跳至主要内容
临床试验/NCT07259655
NCT07259655终止4 期

Management of Post-Induction Hypotension in Emergency Abdominal Surgery: Norepinephrine Versus Ephedrine

Hopital Charles Nicolle1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月6日最近更新:
干预措施

试验速览

阶段
4 期
状态
终止
入组人数
100
试验地点
1
主要终点
Rate of restoration of target blood pressure (Efficacy)

研究概览

简要总结

The goal of this clinical trial is to compare the efficacy of two vasopressors (norepinephrine vs. ephedrine) in treating hypotension in adult patients (aged 18+, ASA I-III) undergoing general anesthesia for abdominal surgical emergencies (e.g., appendicitis, intestinal obstruction, peritonitis). The main questions it aims to answer are:

  • Which drug is more effective at maintaining intraoperative blood pressure (SBP ≥ 80% of baseline)?
  • How many boluses of each vasopressor are required to maintain target blood pressure?

Researchers will compare the norepinephrine group (receiving 10 µg boluses) to the ephedrine group (receiving 6 mg boluses) to see if norepinephrine is superior for maintaining hemodynamic stability and reduces the number of interventions needed.

Participants will:

  • Be randomly assigned to receive one of the two study drugs.
  • Undergo standard general anesthesia with close hemodynamic monitoring.
  • Receive boluses of the assigned vasopressor whenever their blood pressure drops below a predefined threshold.

详细描述

Post-induction hypotension is a frequent and clinically significant event in patients undergoing emergency abdominal surgery, where baseline hemodynamic instability and reduced physiological reserve are common. The combination of absolute or relative hypovolemia, systemic inflammation, sepsis, and the cardiovascular depressive effects of anesthetic drugs increases the likelihood of early intraoperative hypotension. Preventing and promptly correcting this hemodynamic deterioration is essential, as sustained hypotension has been associated with renal injury, myocardial ischemia, and increased postoperative morbidity.

Ephedrine has historically been used as the first-line agent for anesthesia-induced hypotension because of its mixed α- and β-adrenergic activity. However, concerns regarding tachycardia, variable efficacy, and diminished responsiveness in catecholamine-depleted states have encouraged interest in using diluted norepinephrine as an alternative. Low-dose norepinephrine boluses provide predominantly α-adrenergic vasoconstriction with minimal chronotropic effect, offering a potentially more stable hemodynamic profile. Recent evidence from obstetric and non-obstetric anesthesia suggests that norepinephrine may be effective in restoring blood pressure while reducing heart rate fluctuations.

This randomized double-blind study was designed to compare norepinephrine boluses with ephedrine boluses for the management of anesthesia-induced hypotension in the specific setting of emergency abdominal surgery. The study aims to better characterize the hemodynamic response to each drug in a high-risk population frequently presenting with metabolic disturbances, fluid deficits, and variable sympathetic tone. By evaluating the need for repeated vasopressor administration and the rapidity of blood pressure restoration, the study seeks to determine whether norepinephrine may offer superior intraoperative stability compared with the traditional use of ephedrine. The findings may contribute to optimizing vasopressor strategies in emergency surgical anesthesia and reducing short-term hemodynamic complications.

Conditions Conditions: Post-induction Hypotension Keywords: norepinephrine ephedrine post-induction hypotension general anesthesia abdominal emergency Study Design Study Type: Interventional The intraoperative protocol begins with standard patient preparation including verification of the pre-anesthesia checklist and initiation of monitoring with ECG, pulse oximetry and non-invasive blood pressure measurements at 3minute intervals. Three baseline hemodynamic measurements are recorded and averaged to establish reference values, while two 18G peripheral venous lines are secured for fluid and medication administration. Preload status is assessed using ultrasound measurement of inferior vena cava collapsibility, with crystalloid fluid administration of 10-20 mL/kg initiated if the collapsibility index exceeds 40-50%. Following preoxygenation with 100% FiO2, rapid sequence induction is performed using propofol 2-5 mg/kg and succinylcholine 1 mg/kg, followed by endotracheal intubation confirmed by capnography. Anesthesia maintenance consists of propofol infusion at 6-12 mg/kg/h, fentanyl 2-3 μg/kg for analgesia, and intermittent cisatracurium for neuromuscular blockade, with mechanical ventilation parameters set to 6-8 mL/kg tidal volume and 16-25 breaths per minute targeting end-tidal CO2 of 35-45 mmHg. Hypotension, defined as SBP <90 mmHg, MAP <65 mmHg or a 20% decrease from baseline, is managed with 2 mL boluses of the study drug (either 6 mg ephedrine or 10 μg norepinephrine) repeated after 1 minute if needed, with escalation to norepinephrine infusion at 0.25 mg/mL for refractory cases. Hemodynamic parameters are recorded every 3 minutes for the first 20 minutes post-induction and every 5 minutes thereafter, with documentation of hypotensive episodes, vasopressor requirements, and any adverse hemodynamic events including hypertension, bradycardia or tachycardia. The procedure concludes with extubation when standard criteria are met and transfer to the post-anesthesia care unit for continued monitoring.

Statistical Analysis: Data entry and analysis will be performed using SPSS software (version 25.0). Graphical representations will be prepared using Microsoft Excel 2019.

研究设计

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

入排标准

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

入选标准

  • Age > 18 years.
  • Digestive emergencies: Appendicitis, cholecystitis, peritonitis, penetrating wounds, strangulated hernia or eventration, intestinal obstruction, complicated diverticulitis, mesenteric ischemia, gastrointestinal perforation.
  • Patients classified according to the American Society of Anesthesiologists (ASA) classification as I, II, and stable III

排除标准

  • Non-consenting patients.
  • Presence of a rhythm disorder.
  • Patients with pulmonary hypertension .
  • heart failure.
  • intra-abdominal hypertension.
  • Presence of active bleeding.
  • patients using vasopressors at the start of the procedure.
  • pregnant women.
  • Septic or hemorrhagic shock requiring catecholamines.

研究组 & 干预措施

Group 1 (Ephedrine group)

Active Comparator

Participants receive ephedrine 6 mg IV boluses for the management of anesthesia-induced hypotension during emergency abdominal surgery.

干预措施: Ephedrine (6 mg boluses) (Drug)

Group 2 (Norepinephrine group)

Active Comparator

Participants receive diluted norepinephrine 10 µg IV boluses for the management of anesthesia-induced hypotension during emergency abdominal surgery.

干预措施: Norepinephrine (10 µg boluses) (Drug)

结局指标

主要结局

Rate of restoration of target blood pressure (Efficacy)

时间窗: Within 3 to 6 minutes post-hypotensive episode

Percentage of hypotensive episodes where the systolic blood pressure (SBP) was successfully restored to ≥ 80% of the baseline value within the defined time frame.

次要结局

  • Number of vasopressor boluses required(Within 3 to 6 minutes post-hypotensive episode)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

jebri alia

Head of Anesthesiology and Intensive Care Department at Charles Nicolle Hospital in Tunis

Hopital Charles Nicolle

研究点 (1)

Loading locations...

相似试验