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Post-induction HypotensionPhase 4NCT07259655

Management of Post-Induction Hypotension in Emergency Abdominal Surgery

A Phase 4 study testing Ephedrine (6 mg boluses) and Norepinephrine (10 µg boluses) in people with Post-induction Hypotension, run by Hopital Charles Nicolle at 1 site in Tunisia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-induction Hypotension
What is being tested?
Ephedrine (6 mg boluses) and Norepinephrine (10 µg boluses)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteTunisia
Study dates
6 Mar 2025to 6 May 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Non-consenting patients.
  • Presence of a rhythm disorder.
  • Patients with pulmonary hypertension .
  • heart failure.
  • intra-abdominal hypertension.
  • Presence of active bleeding.
Show all 9Show fewer
  • patients using vasopressors at the start of the procedure.
  • pregnant women.
  • Septic or hemorrhagic shock requiring catecholamines.

Trial locations and contacts

1 site in 1 country.

Tunisia1 site
  • Hospital of Charles Nicolle

    Tunis, Tunis Governorate, 1006

Other trials in Tunisia

About this study

Official title: Management of Post-Induction Hypotension in Emergency Abdominal Surgery: Norepinephrine Versus Ephedrine

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?
Read more

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.
Read the detailed description

Post-induction hypotension is a frequent and clinically significant event in patients undergoing emergency abdominal surgery, where baseline hemodynamic instability and reduced physiological reserve are common. The combination of absolute or relative hypovolemia, systemic inflammation, sepsis, and the cardiovascular depressive effects of anesthetic drugs increases the likelihood of early intraoperative hypotension. Preventing and promptly correcting this hemodynamic deterioration is essential, as sustained hypotension has been associated with renal injury, myocardial ischemia, and increased postoperative morbidity.

Ephedrine has historically been used as the first-line agent for anesthesia-induced hypotension because of its mixed α- and β-adrenergic activity. However, concerns regarding tachycardia, variable efficacy, and diminished responsiveness in catecholamine-depleted states have encouraged interest in using diluted norepinephrine as an alternative. Low-dose norepinephrine boluses provide predominantly α-adrenergic vasoconstriction with minimal chronotropic effect, offering a potentially more stable hemodynamic profile. Recent evidence from obstetric and non-obstetric anesthesia suggests that norepinephrine may be effective in restoring blood pressure while reducing heart rate fluctuations.

This randomized double-blind study was designed to compare norepinephrine boluses with ephedrine boluses for the management of anesthesia-induced hypotension in the specific setting of emergency abdominal surgery. The study aims to better characterize the hemodynamic response to each drug in a high-risk population frequently presenting with metabolic disturbances, fluid deficits, and variable sympathetic tone. By evaluating the need for repeated vasopressor administration and the rapidity of blood pressure restoration, the study seeks to determine whether norepinephrine may offer superior intraoperative stability compared with the traditional use of ephedrine. The findings may contribute to optimizing vasopressor strategies in emergency surgical anesthesia and reducing short-term hemodynamic complications.

Conditions Conditions: Post-induction Hypotension Keywords: norepinephrine ephedrine post-induction hypotension general anesthesia abdominal emergency Study Design Study Type: Interventional The intraoperative protocol begins with standard patient preparation including verification of the pre-anesthesia checklist and initiation of monitoring with ECG, pulse oximetry and non-invasive blood pressure measurements at 3minute intervals. Three baseline hemodynamic measurements are recorded and averaged to establish reference values, while two 18G peripheral venous lines are secured for fluid and medication administration. Preload status is assessed using ultrasound measurement of inferior vena cava collapsibility, with crystalloid fluid administration of 10-20 mL/kg initiated if the collapsibility index exceeds 40-50%. Following preoxygenation with 100% FiO2, rapid sequence induction is performed using propofol 2-5 mg/kg and succinylcholine 1 mg/kg, followed by endotracheal intubation confirmed by capnography. Anesthesia maintenance consists of propofol infusion at 6-12 mg/kg/h, fentanyl 2-3 μg/kg for analgesia, and intermittent cisatracurium for neuromuscular blockade, with mechanical ventilation parameters set to 6-8 mL/kg tidal volume and 16-25 breaths per minute targeting end-tidal CO2 of 35-45 mmHg. Hypotension, defined as SBP <90 mmHg, MAP <65 mmHg or a 20% decrease from baseline, is managed with 2 mL boluses of the study drug (either 6 mg ephedrine or 10 μg norepinephrine) repeated after 1 minute if needed, with escalation to norepinephrine infusion at 0.25 mg/mL for refractory cases. Hemodynamic parameters are recorded every 3 minutes for the first 20 minutes post-induction and every 5 minutes thereafter, with documentation of hypotensive episodes, vasopressor requirements, and any adverse hemodynamic events including hypertension, bradycardia or tachycardia. The procedure concludes with extubation when standard criteria are met and transfer to the post-anesthesia care unit for continued monitoring.

Statistical Analysis: Data entry and analysis will be performed using SPSS software (version 25.0). Graphical representations will be prepared using Microsoft Excel 2019.

Descriptive Analysis: Normally distributed continuous quantitative variables will be summarized as mean ± standard deviation. Non-normally distributed continuous variables will be reported as median and interquartile range [IQR: 25%-75%]. Categorical variables will be presented as absolute frequencies (n) and relative frequencies (%).

Analytical Analysis: Associations between two categorical variables will be assessed using Pearson's chi-square test when conditions are met; otherwise, Fisher's exact test will be applied. For comparisons between a categorical and a normally distributed quantitative variable, Student's t-test will be used, while the Mann-Whitney U test will be employed for non-parametric data. A significance level of p < 0.05 will be considered statistically significant. In multivariate analysis, risk estimates will be expressed as odds ratios (OR) with 95% confidence intervals (95% CI).

Being tested
Ephedrine (6 mg boluses), Norepinephrine (10 µg boluses)
Keywords
norepinephrine, ephedrine, post-induction hypotension, general anesthesia, abdominal emergency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ephedrine (6 mg boluses)Drug

    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.

  • Norepinephrine (10 µg boluses)Drug

    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.

Study groups in NCT07259655
Study groupRoleWhat they receive
Group 1 (Ephedrine group)Active comparatorParticipants receive ephedrine 6 mg IV boluses for the management of anesthesia-induced hypotension during emergency abdominal surgery.
Receives: Drug: Ephedrine (6 mg boluses)
Group 2 (Norepinephrine group)Active comparatorParticipants receive diluted norepinephrine 10 µg IV boluses for the management of anesthesia-induced hypotension during emergency abdominal surgery.
Receives: Drug: Norepinephrine (10 µg boluses)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of restoration of target blood pressure (Efficacy)

    Percentage of hypotensive episodes where the systolic blood pressure (SBP) was successfully restored to ≥ 80% of the baseline value within the defined time frame.

    Measured: Within 3 to 6 minutes post-hypotensive episode

Secondary outcomes (1)
  1. Number of vasopressor boluses required

    The total count of vasopressor boluses (norepinephrine or ephedrine) administered to maintain a systolic blood pressure greater than 80% of its baseline value.

    Measured: Within 3 to 6 minutes post-hypotensive episode

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study start6 Mar 2025
  3. Primary completion6 May 2025
  4. Study completion6 May 2025

Why it stopped: the investigators collected the necessary sample size for the internal validity of the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This randomized double-blind trial compares diluted norepinephrine (10 µg boluses) versus ephedrine (6 mg boluses) for managing anesthesia-induced hypotension during emergency abdominal surgery. Primary objectives: maintain SBP ≥80% of baseline and compare required bolus numbers. Secondary: incidence of tachycardia (HR \>100 bpm), bradycardia (HR \<60 bpm) or hypertension. Inclusion: adults \>18 years with digestive emergencies (appendicitis, obstruction, etc.), ASA I-III stable. Exclusion: arrhythmias, pulmonary hypertension, septic/hemorrhagic shock. 100 patients randomized to two groups (50 each). Medications prepared in identical syringes (A/B) to maintain blinding.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07259655
Sponsor's protocol ID
FWA 00032748
Status last verified
Dec 2025
First submitted
14 Sep 2025
Last updated
11 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Fathy MM, Wahdan RA, Salah AAA, Elnakera AM. Inferior vena cava collapsibility index as a predictor of hypotension after induction of general anesthesia in hypertensive patients. BMC Anesthesiol. 2023 Dec 19;23(1):420. doi: 10.1186/s12871-023-02355-y.

    PubMed 38114949
  • Hassani V, Movaseghi G, Safaeeyan R, Masghati S, Ghorbani Yekta B, Farahmand Rad R. Comparison of Ephedrine vs. Norepinephrine in Treating Anesthesia-Induced Hypotension in Hypertensive Patients: Randomized Double-Blinded Study. Anesth Pain Med. 2018 Aug 26;8(4):e79626. doi: 10.5812/aapm.79626. eCollection 2018 Aug.

    PubMed 30271750
  • Ali Elnabtity AM, Selim MF. Norepinephrine versus Ephedrine to Maintain Arterial Blood Pressure during Spinal Anesthesia for Cesarean Delivery: A Prospective Double-blinded Trial. Anesth Essays Res. 2018 Jan-Mar;12(1):92-97. doi: 10.4103/aer.AER_204_17.

    PubMed 29628561
  • Ngan Kee WD, Lee SWY, Ng FF, Khaw KS. Prophylactic Norepinephrine Infusion for Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery. Anesth Analg. 2018 Jun;126(6):1989-1994. doi: 10.1213/ANE.0000000000002243.

    PubMed 28678073
  • Wong GTC, Irwin MG. Post-induction hypotension: a fluid relationship? Anaesthesia. 2021 Jan;76(1):15-18. doi: 10.1111/anae.15065. Epub 2020 Jul 1. No abstract available.

    PubMed 32609373
  • Bijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007 Aug;107(2):213-20. doi: 10.1097/01.anes.0000270724.40897.8e.

    PubMed 17667564

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ephedrine (6 mg boluses) and Norepinephrine (10 µg boluses) in people with Post-induction Hypotension, run by Hopital Charles Nicolle at 1 site in Tunisia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: the investigators collected the necessary sample size for the internal validity of the study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of restoration of target blood pressure (Efficacy) (time frame: Within 3 to 6 minutes post-hypotensive episode). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07259655, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.

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