NCT07529795

Low-dose Norepinephrine Infusion for Prevention of Post-induction Hypotension in Emergency Surgery for Peritonitis

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Bach Mai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Secondary Peritonitis
• Post-induction Hypotension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: Vietnam