A Phase 4 interventional study of Norepinephrine (0.05 μg/kg/min) and Placebo in Secondary Peritonitis and Post-induction Hypotension, sponsored by Bach Mai Hospital. Not yet recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Bach Mai Hospital · Phase 4, Interventional, and Prevention
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.
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.
167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.
This study's planned enrollment of 60 is below the median of 79 across 106 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →Bach Mai Hospital is the lead sponsor of 10 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a norepinephrine infusion at 0.05 micrograms/kg/min starting 3 minutes before fentanyl during standardized induction of general anesthesia.
Drug: Norepinephrine (0.05 μg/kg/min)
Participants receive 0.9% sodium chloride with the same presentation, timing, and infusion settings as the intervention arm during standardized induction of general anesthesia.
Other: Placebo
Drug page: Norepinephrine
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.
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.
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 intubation
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 intubation
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 intubation
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 intubation
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 intubation
Number of Participants With Bradycardia
Number of participants with bradycardia during the induction-intubation study window. Bradycardia should be defined according to the protocol-specified threshold
Time frame: From start of propofol administration to 10 minutes after endotracheal intubation
Postoperative lactate concentration
Arterial or venous lactate concentration used as an exploratory marker of tissue perfusion and physiologic recovery
Time frame: Preoperative baseline and within 24 hours after surgery
Total Rescue Vasopressor Dose
Total dose of rescue vasopressor administered to treat hypotension during the induction-intubation study window.
Time frame: From baseline before study-drug infusion to 10 minutes after endotracheal intubation
Number of Participants With Tachycardia
Number of participants with tachycardia during the induction-intubation study window. Tachycardia should be defined according to the protocol-specified threshold.
Time frame: From start of propofol administration to 10 minutes after endotracheal intubation
Number of Participants Requiring Atropine
Number of participants who receive atropine according to the protocol-defined criteria during the induction-intubation study window.
Time frame: From start of propofol administration to 10 minutes after endotracheal intubation
Number of Participants With Clinically Significant Arrhythmias
Number of participants with clinically significant arrhythmias during the induction-intubation study window.
Time frame: From start of propofol administration to 10 minutes after endotracheal intubation
Number of Participants Admitted to the Intensive Care Unit After Surgery
Number of participants transferred to the intensive care unit (ICU) after surgery.
Time frame: From end of surgery to hospital discharge
Number of Participants With Early Postoperative Complications
Number of participants with predefined early postoperative complications after surgery.
Time frame: From end of surgery to hospital discharge
Postoperative Length of Stay
Postoperative length of hospital stay from the end of surgery until hospital discharge.
Time frame: From end of surgery to hospital discharge
Plan to share: Undecided — The investigators have not yet determined whether de-identified individual participant data will be shared. Any future data sharing decision will depend on institutional policy, ethics approval requirements, and participant privacy considerations.
No publications or documents are linked to this record.
Start is estimated for Apr 2026; primary completion for Sep 2026, 5 months later.
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Studies of the drug tested here: Norepinephrine
Bach Mai Hospital