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Management of Post-Induction Hypotension in Emergency Abdominal Surgery

NCT07259655 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-11

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the efficacy of two vasopressors (norepinephrine vs. ephedrine) in treating hypotension in adult patients (aged 18+, ASA I-III) undergoing general anesthesia for abdominal surgical emergencies (e.g., appendicitis, intestinal obstruction, peritonitis). The main questions it aims to answer are:

* Which drug is more effective at maintaining intraoperative blood pressure (SBP ≥ 80% of baseline)?
* How many boluses of each vasopressor are required to maintain target blood pressure?

Researchers will compare the norepinephrine group (receiving 10 µg boluses) to the ephedrine group (receiving 6 mg boluses) to see if norepinephrine is superior for maintaining hemodynamic stability and reduces the number of interventions needed.

Participants will:

* Be randomly assigned to receive one of the two study drugs.
* Undergo standard general anesthesia with close hemodynamic monitoring.
* Receive boluses of the assigned vasopressor whenever their blood pressure drops below a predefined threshold.

Conditions

  • Post-induction Hypotension

Interventions

DRUG

Ephedrine (6 mg boluses)

Ephedrine 6 mg IV boluses administered when systolic or diastolic blood pressure decreases by ≥20% from baseline. Bolus may be repeated after 1 minute if hypotension persists.

DRUG

Norepinephrine (10 µg boluses)

Diluted norepinephrine 10 µg IV boluses administered when systolic or diastolic blood pressure decreases by ≥20% from baseline. Bolus may be repeated after 1 minute if hypotension persists.

Sponsors & Collaborators

  • Hopital Charles Nicolle

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-06
Primary Completion
2025-05-06
Completion
2025-05-06

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07259655 on ClinicalTrials.gov