Management of Post-Induction Hypotension in Emergency Abdominal Surgery

NCT07259655 | Terminated Phase 4

• 1 other identifier: FWA 00032748
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

norepinephrine; ephedrine; post-induction hypotension; general anesthesia; abdominal emergency

Outcome Measures

Primary Outcomes (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.

  Within 3 to 6 minutes post-hypotensive episode

Secondary Outcomes (1)

• Number of vasopressor boluses required

  Within 3 to 6 minutes post-hypotensive episode

Study Arms (2)

Group 1 (Ephedrine group)

ACTIVE COMPARATOR

Participants receive ephedrine 6 mg IV boluses for the management of anesthesia-induced hypotension during emergency abdominal surgery.

Drug: Ephedrine (6 mg boluses)

Group 2 (Norepinephrine group)

ACTIVE COMPARATOR

Participants receive diluted norepinephrine 10 µg IV boluses for the management of anesthesia-induced hypotension during emergency abdominal surgery.

Drug: Norepinephrine (10 µg boluses)

Interventions

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.

Group 2 (Norepinephrine group)

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.

Group 1 (Ephedrine group)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Charles Nicolle: lead

Study Sites (1)

Hospital of Charles Nicolle

Tunis, Tunis Governorate, 1006, Tunisia

Location

Related Publications (6)

• 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.

  PMID: 38114949 BACKGROUND

• 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.

  PMID: 30271750 BACKGROUND

• 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.

  PMID: 29628561 BACKGROUND

• 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.

  PMID: 28678073 BACKGROUND

• 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.

  PMID: 32609373 BACKGROUND

• 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.

  PMID: 17667564 BACKGROUND

MeSH Terms

Interventions

Ephedrine; Norepinephrine

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology and Intensive Care Department at Charles Nicolle Hospital in Tunis

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: December 2, 2025
• Study Start: March 6, 2025
• Primary Completion: May 6, 2025
• Study Completion: May 6, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

TU (1)