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

ConditionsHypotension on InductionEmergency SurgeryNorepinephrine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Norepinephrine 10 mcg

    Drug

    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.

  • Norepinephrine 5 mcg

    Drug

    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.

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: Norepinephrine 5-mcg groupActive comparator 1 intervention
Group B: Norepinephrine 10-mcg groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of successfully managed hypotensive episode

mean arterial pressure \>65 mmHg within 2 min of drug administration

Time frame
from 0 min of induction of anesthesia until 30 min after skin incision

Secondary outcomes

1

Area under a mean arterial pressure of 65 mmHg

The area under a mean arterial pressure (MAP) of 65 mm Hg will be calculated by subtracting MAP measurements from 65 mm Hg, multiplying positive differences with the time difference (in minutes) between this MAP measurement and the consecutive MAP measurement, and summing the values

Time frame
from 0 min of induction of anesthesia until 30 min after skin incision
2

Duration of MAP<65 mmHg

in minutes

Time frame
from 0 min after induction of anesthesia until 30 min after skin incision
3

bradycardia

heart rate \< 50 bpm following drug administration

Time frame
from 0 min after induction of anesthesia until 30 min after skin incision
4

hypertension

systolic blood pressure \>120% of baseline following drug administration

Time frame
from 0 min after induction of anesthesia until 30 min after skin incision

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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