Low-dose Norepinephrine Infusion for Prevention of Post-induction Hypotension in Emergency Surgery for Peritonitis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBach Mai Hospital
About this trial
This study tests whether giving a low-dose norepinephrine infusion just before induction of anesthesia can reduce low blood pressure during emergency surgery for peritonitis. Adults with secondary peritonitis who are scheduled for emergency surgery and have stable blood pressure after initial resuscitation will be randomly assigned to receive either norepinephrine or placebo (normal saline) during induction of anesthesia. The main outcome is the cumulative time spent with mean arterial pressure (MAP) below 65 mmHg from the start of propofol administration to 10 minutes after endotracheal intubation. The study will also evaluate rescue vasopressor use, heart rate changes, drug-related adverse events, and selected early postoperative outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Secondary peritonitis requiring emergency surgery under general anesthesia with endotracheal intubation.
Planned induction with fentanyl, propofol, and rocuronium according to the study protocol.
Hemodynamically stabilized after initial resuscitation, with MAP at least 65 mmHg and no ongoing vasopressor infusion before induction.
Disqualifiers
Allergy or contraindication to norepinephrine, propofol, fentanyl, or rocuronium.
Severe cardiovascular disease likely to confound hemodynamic assessment, including decompensated heart failure, acute coronary syndrome, severe arrhythmia, severe valvular disease, or major cardiomyopathy.
Ongoing vasopressor therapy before induction.
Shock before surgery, including hypovolemic, septic, or cardiogenic shock.
Trial design
Design model
Parallel
Treatments tested in this trial
Norepinephrine (0.05 μg/kg/min)
DrugNorepinephrine prepared in a blinded syringe and infused continuously at 0.05 micrograms/kg/min starting 3 minutes before fentanyl during induction of general anesthesia. Infusion is adjusted or temporarily stopped according to the protocol-defined hemodynamic safety algorithm.
Placebo
Other interventionPlacebo: 0.9% Sodium Chloride prepared in a blinded syringe and administered with the same timing, presentation, and pump settings as the active study drug.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Low-dose norepinephrine infusionExperimental treatment 1 intervention
Group B: 0.9% sodium chloride infusionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative duration of MAP below 65 mmHg during induction
Total time with mean arterial pressure below 65 mmHg, derived from time-stamped arterial line data after removal of artifacts.
Time frame
From start of propofol administration to 10 minutes after endotracheal intubationSecondary outcomes
1
Incidence of MAP below 65 mmHg
Proportion of participants with at least one episode of MAP below 65 mmHg.
Time frame
From start of propofol administration to 10 minutes after endotracheal intubation2
Incidence of severe hypotension (MAP below 55 mmHg)
Proportion of participants with at least one episode of MAP below 55 mmHg.
Time frame
From start of propofol administration to 10 minutes after endotracheal intubation3
Largest decrease in MAP from baseline
Maximum absolute and relative reduction in MAP compared with baseline.
Time frame
From baseline before study-drug infusion to 10 minutes after endotracheal intubation4
Number of Participants Requiring Rescue Vasopressor
Number of participants who receive any rescue vasopressor to treat hypotension during the induction-intubation study window.
Time frame
From baseline before study-drug infusion to 10 minutes after endotracheal intubationSponsors and contacts
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Source ClinicalTrials.gov
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