Postinduction HypotensionNCT07722013
Intermittent Ephedrine Boluses for Prophylaxis Against Postinduction Hypotension
A study testing Normal Saline and Ephedrine in people with Postinduction Hypotension, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this work is to assess the efficacy of intermittent ephedrine boluses in prophylaxis against postinduction hypotension in high-risk patients undergoing major abdominal surgery, compared to standard care. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Postinduction Hypotension
- What is being tested?
- Normal Saline and Ephedrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged >50 years,
- weight >50 kg,
- American Society of Anesthesiologists (ASA) Physical Status score of > I,
- undergoing major abdominal surgery
Who cannot join
- Severe cardiac morbidities (impaired contractility with ejection fraction < 40%, heart block, significant uncontrolled arrhythmias, tight stenotic valvular lesions)
- Acute cardiovascular pathologies: acute/decompensated heart failure, acute coronary syndrome
- Uncontrolled hypertension (systolic blood pressure>150 mmHg)
- Preoperative HR more than 110 bpm despite proper fluid management and patients with renal impairment
- Renal impairment
- Patients on vasopressor infusion,
- 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
Kasr Alainy Hospital
Cairo, 11562
ahmed hasanin, 01095076954 ext. +2, ahmedmohamedhasanin@gmail.com
About this study
Official title: Intermittent Ephedrine Boluses for Prophylaxis Against Postinduction Hypotension in High-risk Patients Undergoing Major Abdominal Surgery: a Randomized Double-blinded Controlled Trial: a Randomized Double-blinded Controlled Trial
The aim of this work is to assess the efficacy of intermittent ephedrine boluses in prophylaxis against postinduction hypotension in high-risk patients undergoing major abdominal surgery, compared to standard care.
Read the detailed description
Fluid responders (≥20% rise in perfusion index on passive leg raising) will receive 500-mL Ringer's boluses (up to 1500 mL). Anesthesia will be induced with fentanyl/propofol, intubated after neuromuscular blockade, and maintained with isoflurane (1.2% end-tidal). Study drug will be given at induction and every 5 minutes for 20 minutes, withheld if MAP ≥80 mmHg or a recent vasopressor dose. Hypotension (MAP <65 mmHg) will be treated with 0.1 mg/kg ephedrine boluses (max 9 mg single). Post-incision care follows anesthetist discretion.
- Conditions
- Postinduction Hypotension
- Being tested
- Normal Saline, Ephedrine
- Keywords
- major abdominal surgery, high risk patients, ephedrine, prophylaxis, postinduction hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
four 10-mL syringes of normal saline, The patient will receive the first dose of the intervention with induction (0.1 ml/kg). After induction of anesthesia, the study drug will be given every 5 min for 20 min and will be withheld if MAP was ≥80 mmHg or if any vasopressor is given within 2 min of the current scheduled dose
EphedrineDrug
four 10-mL syringes of ephedrine 1 mg/mL. The patient will receive the first dose of the intervention with induction (0.1 ml/kg). After induction of anesthesia, the study drug will be given every 5 min for 20 min and will be withheld if MAP was ≥80 mmHg or if any vasopressor is given within 2 min of the current scheduled dose.
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | Normal Saline boluses Receives: Drug: Normal Saline |
| ephedrine | Active comparator | ephedrine boluses Receives: Drug: Ephedrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postinduction hypotension
mean arterial pressure < 65 mmHg
Measured: from induction of anesthesia until 20 minutes after induction
Secondary outcomes (1)
area under mean arterial pressure of 65 mmHg
Measured: from induction of anesthesia until 20 minutes after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 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 Postinduction HypotensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 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
- NCT07722013
- Sponsor's protocol ID
- MD-160-2026
- Status last verified
- Aug 2026
- First submitted
- 19 Jul 2026
- Last updated
- 6 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 protocol are available from principle investigator upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Ephedrine Boluses for Prophylaxis Against Postinduction Hypotension in High-risk Patients Undergoing Major Abdominal Surgery: a Randomized Double-blinded Controlled Trial: a Randomized Double-blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT07722013
- Acronym / sponsor ID
- MD-160-2026
- Conditions
- Postinduction Hypotension
- Keywords
- major abdominal surgery, high risk patients, ephedrine, prophylaxis, postinduction hypotension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 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
- 23 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.
The aim of this work is to assess the efficacy of intermittent ephedrine boluses in prophylaxis against postinduction hypotension in high-risk patients undergoing major abdominal surgery, compared to standard care.
Detailed description
Fluid responders (≥20% rise in perfusion index on passive leg raising) will receive 500-mL Ringer's boluses (up to 1500 mL). Anesthesia will be induced with fentanyl/propofol, intubated after neuromuscular blockade, and maintained with isoflurane (1.2% end-tidal). Study drug will be given at induction and every 5 minutes for 20 minutes, withheld if MAP ≥80 mmHg or a recent vasopressor dose. Hypotension (MAP <65 mmHg) will be treated with 0.1 mg/kg ephedrine boluses (max 9 mg single). Post-incision care follows anesthetist discretion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Drug: Normal SalineNormal Saline boluses |
| ephedrine | Active comparator | Drug: Ephedrineephedrine boluses |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged >50 years,
- weight >50 kg,
- American Society of Anesthesiologists (ASA) Physical Status score of > I,
- undergoing major abdominal surgery
Key exclusion criteria (7 listed)
- Severe cardiac morbidities (impaired contractility with ejection fraction < 40%, heart block, significant uncontrolled arrhythmias, tight stenotic valvular lesions)
- Acute cardiovascular pathologies: acute/decompensated heart failure, acute coronary syndrome
- Uncontrolled hypertension (systolic blood pressure>150 mmHg)
- Preoperative HR more than 110 bpm despite proper fluid management and patients with renal impairment
- Renal impairment
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 |
|---|---|---|
| Normal Salinefour 10-mL syringes of normal saline, The patient will receive the first dose of the intervention with induction (0.1 ml/kg). After induction of anesthesia, the study drug will be given every 5 min for 20 min and will be withheld if MAP was ≥80 mmHg or if any vasopressor is given within 2 min of the current scheduled dose | Drug | control |
| Ephedrinefour 10-mL syringes of ephedrine 1 mg/mL. The patient will receive the first dose of the intervention with induction (0.1 ml/kg). After induction of anesthesia, the study drug will be given every 5 min for 20 min and will be withheld if MAP was ≥80 mmHg or if any vasopressor is given within 2 min of the current scheduled dose. | Drug | ephedrine |
Primary outcome
incidence of postinduction hypotension
Time frame: from induction of anesthesia until 20 minutes after induction
mean arterial pressure < 65 mmHg
1 secondary outcome
area under mean arterial pressure of 65 mmHg
Time frame: from induction of anesthesia until 20 minutes after induction
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 6 Aug 2026.
- Individual participant dataSharing planned: No. data related to this protocol are available from principle investigator upon reasonable request
Related trials for Postinduction Hypotension
Not yet recruitingObservational study
SV and IVC Collapsibility Index to Predict Postinduction Hypotension
Post-induction Hypotension, Intestinal Obstruction
Recruiting
5 Versus 10 mcg Norepinephrine Bolus in Treatment of Postinduction and Early Intraoperative Hypotension in Emergency Abdominal Surgery
Hypotension on Induction, Emergency Surgery
Recruiting
Continuous Versus Bolus Norepinephrine Administration to Treat Postinduction Hypotension
Postinduction Hypotension
Active, not recruiting
Pre-op Fluid Study
Hypotension Drug-Induced, Anesthesia
Enrolling by invitationPhase 4
The Effect of Preoperative Intravenous Fluid Bolus on Post-induction Hypotension in Elective Cystoscopies.
Postinduction Hypotension, Hypotension During Surgery
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 Normal Saline and Ephedrine in people with Postinduction Hypotension, 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 4 inclusion and 7 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 6 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. Some participants in this study may receive a placebo. 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 postinduction hypotension (time frame: from induction of anesthesia until 20 minutes after induction). 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 6 Aug 2026.