Low-dose Norepinephrine Infusion for Prevention of Post-induction Hypotension in Emergency Surgery for Peritonitis
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 (0.05 μg/kg/min), Placebo.
- Who it may be relevant to
- Registry conditions: Secondary Peritonitis, Post-induction Hypotension. Basic parameters: from 18 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
- Vietnam
- 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
Protocolized Low-dose Norepinephrine Infusion for Prevention of Post-induction Hypotension in Adults Undergoing Emergency Surgery for Secondary Peritonitis: A Randomized Double-blind Placebo-controlled Trial
Overview
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.
Detailed description
The study is a single-center, randomized, double-blind, placebo-controlled interventional trial conducted at the Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital, Hanoi, Vietnam.
Adults undergoing emergency surgery for secondary peritonitis often have marked hemodynamic vulnerability during induction of general anesthesia because of systemic inflammation, vasodilation, capillary leak, and relative hypovolemia. Propofol-based induction may further reduce arterial pressure and organ perfusion in this setting.
Participants who meet eligibility criteria and have a mean arterial pressure (MAP) of at least 65 mmHg after initial resuscitation, without ongoing vasopressor support, will be enrolled and randomized 1:1 to a norepinephrine infusion group or a placebo group.
In the intervention group, norepinephrine will be infused at 0.05 micrograms/kg/min starting 3 minutes before fentanyl. In the placebo group, 0.9% sodium chloride will be infused with the same presentation, timing, and pump settings.
All participants will undergo a standardized induction protocol with fentanyl, titrated propofol, rocuronium, arterial line monitoring before induction, and protocolized hemodynamic rescue treatment.
The primary endpoint is the cumulative duration of MAP below 65 mmHg during the induction-intubation window, defined from the start of propofol administration to 10 minutes after endotracheal intubation. Secondary endpoints include the incidence of MAP below 65 and below 55 mmHg, the largest decrease in MAP from baseline, heart-rate changes, rescue vasopressor requirements, atropine use, and predefined early postoperative outcomes.
Interventions
- Drug Norepinephrine (0.05 μg/kg/min)
Norepinephrine 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. - Other Placebo
Placebo: 0.9% Sodium Chloride prepared in a blinded syringe and administered with the same timing, presentation, and pump settings as the active study drug.
Primary outcome measures
- Cumulative duration of MAP below 65 mmHg during induction [Time frame: From start of propofol administration to 10 minutes after endotracheal intubation]
Secondary outcome measures (12)
- Incidence of MAP below 65 mmHg [Time frame: From start of propofol administration to 10 minutes after endotracheal intubation]
- Incidence of severe hypotension (MAP below 55 mmHg) [Time frame: From start of propofol administration to 10 minutes after endotracheal intubation]
- Largest decrease in MAP from baseline [Time frame: From baseline before study-drug infusion to 10 minutes after endotracheal intubation]
- Number of Participants Requiring Rescue Vasopressor [Time frame: From baseline before study-drug infusion to 10 minutes after endotracheal intubation]
- Number of Participants With Bradycardia [Time frame: From start of propofol administration to 10 minutes after endotracheal intubation]
- Postoperative lactate concentration [Time frame: Preoperative baseline and within 24 hours after surgery]
- Total Rescue Vasopressor Dose [Time frame: From baseline before study-drug infusion to 10 minutes after endotracheal intubation]
- Number of Participants With Tachycardia [Time frame: From start of propofol administration to 10 minutes after endotracheal intubation]
- Number of Participants Requiring Atropine [Time frame: From start of propofol administration to 10 minutes after endotracheal intubation]
- Number of Participants With Clinically Significant Arrhythmias [Time frame: From start of propofol administration to 10 minutes after endotracheal intubation]
- Number of Participants Admitted to the Intensive Care Unit After Surgery [Time frame: From end of surgery to hospital discharge]
- Number of Participants With Early Postoperative Complications [Time frame: From end of surgery to hospital discharge]
Eligibility criteria
Inclusion criteria
- 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.
- ASA physical status I to III.
- Written informed consent from the participant or a legally authorized representative.
Exclusion criteria
- 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.
- Severe hypertension before induction (systolic blood pressure >180 mmHg or mean arterial pressure >110 mmHg).
- Severe peripheral vascular disease or clinically significant limb ischemia.
- Current monoamine oxidase inhibitor use.
- Pregnancy or breastfeeding.
- Contraindication to arterial catheter placement.
- Refusal of consent.
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
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Vietnam · 1 center
- Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital — Hanoi
Identifiers
NCT: NCT07529795 · TTGMHS-NA-PP-2026-02