5 Versus 10 mcg Norepinephrine Bolus in Treatment of Postinduction and Early Intraoperative Hypotension in Emergency Abdominal Surgery

NCT07719075 | Not Yet Recruiting

• 1 other identifier: MS-303-2026
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Postinduction hypotension is a frequent intraoperative complication, particularly in emergency abdominal surgery due to factors such as sepsis, hypovolemia, and limited preoperative cardiac assessment. Because it can lead to serious organ injury, prompt prevention and management are essential. Vasopressors, including ephedrine, phenylephrine, and norepinephrine, are commonly used, with NE gaining interest as an intraoperative bolus despite uncertainty about the optimal dose in general surgery population The aim of this study is to compare 5 mcg to 10 mcg norepinephrine bolus for treatment of postinduction hypotension and early intraoperative in emergency abdominal surgery.

Conditions

Hypotension on Induction; Emergency Surgery; Norepinephrine

Keywords

hypotension; norepinephrine; emergency surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of successfully managed hypotensive episode

  mean arterial pressure \>65 mmHg within 2 min of drug administration

  from 0 min of induction of anesthesia until 30 min after skin incision

Secondary Outcomes (4)

• Area under a mean arterial pressure of 65 mmHg

  from 0 min of induction of anesthesia until 30 min after skin incision

• Duration of MAP<65 mmHg

  from 0 min after induction of anesthesia until 30 min after skin incision

• bradycardia

  from 0 min after induction of anesthesia until 30 min after skin incision

• hypertension

  from 0 min after induction of anesthesia until 30 min after skin incision

Study Arms (2)

Norepinephrine 5-mcg group

ACTIVE COMPARATOR

The study drug will be prepared by diluting 4000 mcg of NE in 400 mL of normal saline to achieve a concentration of 10 mcg/mL. The assigned dose (5 mcg, 0.5 mL of the prepared solution) will then be further diluted with normal saline in a 10-mL syringe.

Drug: Norepinephrine 5 mcg

Norepinephrine 10-mcg group

ACTIVE COMPARATOR

The study drug will be prepared by diluting 4000 mcg of NE in 400 mL of normal saline to achieve a concentration of 10 mcg/mL. The assigned dose (10 mcg, 1 mL of the prepared solution) will then be further diluted with normal saline in a 10-mL syringe.

Drug: Norepinephrine 10 mcg

Interventions

Norepinephrine 10 mcg DRUG

Norepinephrine dose of 10 mcg will be given if patient developed hypotension (mean arterial pressure \<65 mmHg). The norepinephrine bolus (10 mcg) will be repeated if mean arterial pressure is not restored within 2 min. Norepinephrine infusion will be started if hypotension persisted after three boluses.

Norepinephrine 10-mcg group

Norepinephrine 5 mcg DRUG

Norepinephrine dose of 5 mcg will be given if patient developed hypotension (mean arterial pressure \<65 mmHg). The norepinephrine bolus (5 mcg) will be repeated if mean arterial pressure is not restored within 2 min. Norepinephrine infusion will be started if hypotension persisted after three boluses.

Norepinephrine 5-mcg group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, American Society of anesthesiologists (ASA) I-III undergoing emergency abdominal surgery

You may not qualify if:

• Severe cardiac morbidities (impaired contractility with ejection fraction \< 45%, heart block, arrhythmias, tight valvular lesions)
• Patients on vasopressor infusion,
• Pregnant or lactating women,
• Allergy of any of the study drugs

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Hypotension

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular 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

Maha Mostafa, MD

CONTACT

+201000365115; maha.mostafa@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: Professor

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)