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

NCT07529795 | Not Yet Recruiting Phase 4

• 1 other identifier: TTGMHS-NA-PP-2026-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Secondary Peritonitis; Post-induction Hypotension

Keywords

Emergency surgery; General anesthesia; Norepinephrine; Noradrenaline; Induction hypotension; Mean arterial pressure

Outcome Measures

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.

  From start of propofol administration to 10 minutes after endotracheal intubation

Secondary Outcomes (13)

• Incidence of MAP below 65 mmHg

  From start of propofol administration to 10 minutes after endotracheal intubation

• Incidence of severe hypotension (MAP below 55 mmHg)

  From start of propofol administration to 10 minutes after endotracheal intubation

• Largest decrease in MAP from baseline

  From baseline before study-drug infusion to 10 minutes after endotracheal intubation

• Number of Participants Requiring Rescue Vasopressor

  From baseline before study-drug infusion to 10 minutes after endotracheal intubation

• Number of Participants With Bradycardia

  From start of propofol administration to 10 minutes after endotracheal intubation

Study Arms (2)

Low-dose norepinephrine infusion

EXPERIMENTAL

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)

0.9% sodium chloride infusion

PLACEBO COMPARATOR

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

Interventions

Norepinephrine (0.05 μg/kg/min) DRUG

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.

Low-dose norepinephrine infusion

Placebo OTHER

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.

0.9% sodium chloride infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bach Mai Hospital: lead

Study Sites (1)

Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Peritonitis

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Thang Toan Nguyen, PhD

CONTACT

+084916874795; nguyentoanthang@hmu.edu.vn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study drug syringes will be prepared by personnel not involved in anesthesia management, postoperative assessment, or statistical analysis. Participants, anesthesia care providers, investigators, outcome assessors, and statisticians will remain blinded to treatment allocation until database lock unless unblinding is required for participant safety.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesiologist, Director of Center for Anesthesia and Surgical ICU

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 14, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

VN (1)