Hypotension on InductionNCT07719075
5 Versus 10 mcg Norepinephrine Bolus in Treatment of Postinduction and Early Intraoperative Hypotension in Emergency Abdominal Surgery
A study testing Norepinephrine 10 mcg and Norepinephrine 5 mcg in people with Hypotension on Induction and Emergency Surgery, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Hypotension on Induction, Emergency Surgery, Norepinephrine
- What is being tested?
- Norepinephrine 10 mcg and Norepinephrine 5 mcg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Aug 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, American Society of anesthesiologists (ASA) I-III undergoing emergency abdominal surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, Cairo Governorate
ahmed Hasanin, Lecturer, +2010095076954, ahmedmohamedhasanin@gmail.com
About this study
Official title: Comparing 5 mcg and 10 mcg Norepinephrine Bolus in Treatment of Postinduction and Early Intraoperative Hypotension in Emergency Abdominal Surgery: a Randomized Controlled Trial
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.
Read the detailed description
fluid assessment using stroke volume change after passive leg raising maneuver will be applied. If stroke volume increase >10%, 500-mL bolus of lactated ringer will be given. Passive leg raising will be repeated until the patient is non-responder or 1500 mL were infused.
intraoperatively, heart rate and blood pressure will be monitored at 2 min intervals until 30 min after skin incision.
- Conditions
- Hypotension on Induction, Emergency Surgery, Norepinephrine
- Being tested
- Norepinephrine 10 mcg, Norepinephrine 5 mcg
- Keywords
- hypotension, norepinephrine, emergency surgery
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norepinephrine 10 mcgDrug
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 5 mcgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Norepinephrine 10 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of successfully managed hypotensive episode
mean arterial pressure >65 mmHg within 2 min of drug administration
Measured: 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
The area under a mean arterial pressure (MAP) of 65 mm Hg will be calculated by subtracting MAP measurements from 65 mm Hg, multiplying positive differences with the time difference (in minutes) between this MAP measurement and the consecutive MAP measurement, and summing the values
Measured: from 0 min of induction of anesthesia until 30 min after skin incision
Duration of MAP<65 mmHg
in minutes
Measured: from 0 min after induction of anesthesia until 30 min after skin incision
bradycardia
heart rate < 50 bpm following drug administration
Measured: from 0 min after induction of anesthesia until 30 min after skin incision
hypertension
systolic blood pressure >120% of baseline following drug administration
Measured: from 0 min after induction of anesthesia until 30 min after skin incision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start4 Aug 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension on InductionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719075
- Sponsor's protocol ID
- MS-303-2026
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data related to this research is available form the PI upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing 5 mcg and 10 mcg Norepinephrine Bolus in Treatment of Postinduction and Early Intraoperative Hypotension in Emergency Abdominal Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07719075
- Acronym / sponsor ID
- MS-303-2026
- Conditions
- Hypotension on Induction, Emergency Surgery, Norepinephrine
- Keywords
- hypotension, norepinephrine, emergency surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
fluid assessment using stroke volume change after passive leg raising maneuver will be applied. If stroke volume increase >10%, 500-mL bolus of lactated ringer will be given. Passive leg raising will be repeated until the patient is non-responder or 1500 mL were infused.
intraoperatively, heart rate and blood pressure will be monitored at 2 min intervals until 30 min after skin incision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine 5-mcg group | Active comparator | Drug: Norepinephrine 5 mcgThe 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. |
| Norepinephrine 10-mcg group | Active comparator | Drug: Norepinephrine 10 mcgThe 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients, American Society of anesthesiologists (ASA) I-III undergoing emergency abdominal surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norepinephrine 10 mcgNorepinephrine 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. | Drug | Norepinephrine 10-mcg group |
| Norepinephrine 5 mcgNorepinephrine 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. | Drug | Norepinephrine 5-mcg group |
Primary outcome
Incidence of successfully managed hypotensive episode
Time frame: from 0 min of induction of anesthesia until 30 min after skin incision
mean arterial pressure >65 mmHg within 2 min of drug administration
4 secondary outcomes
Area under a mean arterial pressure of 65 mmHg
Time frame: from 0 min of induction of anesthesia until 30 min after skin incision
Duration of MAP<65 mmHg
Time frame: from 0 min after induction of anesthesia until 30 min after skin incision
bradycardia
Time frame: from 0 min after induction of anesthesia until 30 min after skin incision
hypertension
Time frame: from 0 min after induction of anesthesia until 30 min after skin incision
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No. data related to this research is available form the PI upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine 10 mcg and Norepinephrine 5 mcg in people with Hypotension on Induction and Emergency Surgery, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. 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 Egypt. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maha Mostafa, MD (+201000365115, maha.mostafa@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of successfully managed hypotensive episode (time frame: from 0 min of induction of anesthesia until 30 min after skin incision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.