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Recruiting NCT07719075

5 Versus 10 mcg Norepinephrine Bolus in Treatment of Postinduction and Early Intraoperative Hypotension in Emergency Abdominal Surgery

No phase Interventional Hypotension on Induction Emergency Surgery Norepinephrine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Norepinephrine 10 mcg, Norepinephrine 5 mcg.
Who it may be relevant to
Registry conditions: Hypotension on Induction, Emergency Surgery, Norepinephrine. Basic parameters: 21 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparing 5 mcg and 10 mcg Norepinephrine Bolus in Treatment of Postinduction and Early Intraoperative Hypotension in Emergency Abdominal Surgery: a Randomized Controlled Trial

Overview

Postinduction hypotension is a frequent intraoperative complication, particularly in emergency abdominal surgery due to factors such as sepsis, hypovolemia, and limited preoperative cardiac assessment. Because it can lead to serious organ injury, prompt prevention and management are essential. Vasopressors, including ephedrine, phenylephrine, and norepinephrine, are commonly used, with NE gaining interest as an intraoperative bolus despite uncertainty about the optimal dose in general surgery population The aim of this study is to compare 5 mcg to 10 mcg norepinephrine bolus for treatment of postinduction hypotension and early intraoperative in emergency abdominal surgery.

Detailed description

fluid assessment using stroke volume change after passive leg raising maneuver will be applied. If stroke volume increase \>10%, 500-mL bolus of lactated ringer will be given. Passive leg raising will be repeated until the patient is non-responder or 1500 mL were infused.

intraoperatively, heart rate and blood pressure will be monitored at 2 min intervals until 30 min after skin incision.

Interventions

  • Drug Norepinephrine 10 mcg
    Norepinephrine dose of 10 mcg will be given if patient developed hypotension (mean arterial pressure \<65 mmHg). The norepinephrine bolus (10 mcg) will be repeated if mean arterial pressure is not restored within 2 min. Norepinephrine infusion will be started if hypotension persisted after three boluses.
  • Drug Norepinephrine 5 mcg
    Norepinephrine dose of 5 mcg will be given if patient developed hypotension (mean arterial pressure \<65 mmHg). The norepinephrine bolus (5 mcg) will be repeated if mean arterial pressure is not restored within 2 min. Norepinephrine infusion will be started if hypotension persisted after three boluses.

Primary outcome measures

  • Incidence of successfully managed hypotensive episode [Time frame: from 0 min of induction of anesthesia until 30 min after skin incision]
Secondary outcome measures (4)
  • Area under a mean arterial pressure of 65 mmHg [Time frame: from 0 min of induction of anesthesia until 30 min after skin incision]
  • Duration of MAP<65 mmHg [Time frame: from 0 min after induction of anesthesia until 30 min after skin incision]
  • bradycardia [Time frame: from 0 min after induction of anesthesia until 30 min after skin incision]
  • hypertension [Time frame: from 0 min after induction of anesthesia until 30 min after skin incision]

Eligibility criteria

Inclusion criteria

  • Adult patients, American Society of anesthesiologists (ASA) I-III undergoing emergency abdominal surgery

Exclusion criteria

  • Severe cardiac morbidities (impaired contractility with ejection fraction < 45%, heart block, arrhythmias, tight valvular lesions)
  • Patients on vasopressor infusion,
  • Pregnant or lactating women,
  • Allergy of any of the study drugs

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Cairo

Identifiers

NCT: NCT07719075 · MS-303-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗