TerminatedPhase 4

Management of Post-Induction Hypotension in Emergency Abdominal Surgery

Stopped: the investigators collected the necessary sample size for the internal validity of the study

Tunisia100 participantsStarted 2025-03-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 years. * Digestive emergencies: Appendicitis, cholecystitis, peritonitis, penetrating wounds, strangulated hernia or eventration, intestinal obstruction, complicated diverticulitis, mesenteric ischemia, gastrointestinal perforation. * Patients classified according to the American Society of Anesthesiologists (ASA) classification as I, II, and stable III Exclusion Criteria: * Non-consenting patients. * Presence of a rhythm disorder. * Patients with pulmonary hypertension . * heart failure. * intra-abdominal hypertension. * Presence of active bleeding. * patients using vasopressors at the start of the procedure. * pregnant women. * Septic or hemorrhagic shock requiring catecholamines.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of restoration of target blood pressure (Efficacy)

Timeframe: Within 3 to 6 minutes post-hypotensive episode

Trial details

NCT IDNCT07259655

SponsorHopital Charles Nicolle

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-06

View on ClinicalTrials.gov More Post-induction Hypotension trials