Post-induction HypotensionPhase 4NCT06772727
Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy
A Phase 4 study testing Lidocaine, Fentanyl and Propofol in people with Post-induction Hypotension and Lidocaine, run by Cairo University at 1 site in Egypt.
Trial summary
Lidocaine-based anesthesia had been recently reported as a successful regimen for induction of anesthesia in elderly population with better hemodynamic profile than opioid-based induction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-induction Hypotension, Lidocaine, Opioid
- What is being tested?
- Lidocaine, Fentanyl and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 30 Oct 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Both gender
- American Society of Anesthesiologists (ASA) class I-III undergoing emergency laparotomy.
Who cannot join
- Patient refusal
- Severe cardiac morbidities (impaired contractility with ejection fraction < 45%, heart block, arrhythmias, tight valvular lesions)
- Baseline mean arterial pressure <75 mmHg
- Patients on vasopressor infusion,
- Patients with high shock index (heart rate / systolic blood pressure >1)
- Pregnant or lactating women,
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- Allergy of any of the study drugs
- Uncontrolled hypertension
- Opioid drug abusers
- Patients with increased intracranial tension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Hemodynamic Effect of Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy: a Randomized Controlled Trial.
Lidocaine-based anesthesia had been recently reported as a successful regimen for induction of anesthesia in elderly population with better hemodynamic profile than opioid-based induction. The investigators hypothesize that lidocaine-based induction of anesthesia would provide superior hemodynamic profile compared to conventional opioid-based induction of anesthesia in emergency laparotomy.
- Conditions
- Post-induction Hypotension, Lidocaine, Opioid, Emergency Laparotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
After preoxygenation with 100% oxygen for 3 minutes, the study drug (lidocaine) will be administered. Patients will receive 1 mg/kg lidocaine of 10 mg/mL lidocaine solution (prepared by diluting 5 mL of lidocaine 20% in saline to a total volume of 10 mL)
FentanylDrug
After preoxygenation with 100% oxygen for 3 minutes, the study drug (fentanyl) will be administered. Patients will receive 1 mcg/kg fentanyl of 10 mcg/mL fentanyl solution (prepared by diluting 100 mcg fentanyl in saline to a total volume of 10 mL).
PropofolDrug
After administration of the study drug, all patients will receive 2 mg/kg propofol intravenously
Succinyl cholineDrug
After loss of consciousness, 1 mg/kg succinyl choline will be administered over 5 seconds, and tracheal intubation will be done through direct laryngoscopy after 60 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine group | Active comparator | Patients will receive 1 mg/kg lidocaine intravenously (IV) Receives: Drug: Lidocaine; Drug: Propofol; Drug: Succinyl choline |
| Fentanyl group | Active comparator | Patients will receive 1 mcg/kg fentanyl intravenously (IV) Receives: Drug: Fentanyl; Drug: Propofol; Drug: Succinyl choline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension
Incidence of post-induction hypotension
Measured: immediately after induction of anesthesia until 20 minutes after induction of anesthesia
Secondary outcomes (3)
Norepinephrine dose
Total norepinephrine dose during the period from induction of anesthesia until 20-minutes after intubation or skin incision
Measured: from induction of anesthesia until 20 minutes after skin incision
Heart rate
Measured: every 2 minutes for 20 minutes after induction of anesthesia
Mean Arterial Pressure
Measured: every 2 minutes for 20 minutes after induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Feb 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-induction 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Mohammed Assem Nawwar, Cairo University
- Investigators
- Jehan Elkholy, M.D., Study chair, Cairo UniversityEman F Ali,, M.D., Study director, Cairo UniversityKareem MA Nawwar, M.D., Study director, Cairo UniversityMohsen M Waheeb, M.D., Study director, Cairo UniversitySamar M Abdel Azeim Ghazala, M.Sc., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772727
- Sponsor's protocol ID
- MD-265-2024
- Status last verified
- Mar 2026
- First submitted
- 3 Jan 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hemodynamic Effect of Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06772727
- Acronym / sponsor ID
- MD-265-2024
- Conditions
- Post-induction Hypotension, Lidocaine, Opioid, Emergency Laparotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 13 Jan 2025 (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.
Lidocaine-based anesthesia had been recently reported as a successful regimen for induction of anesthesia in elderly population with better hemodynamic profile than opioid-based induction. The investigators hypothesize that lidocaine-based induction of anesthesia would provide superior hemodynamic profile compared to conventional opioid-based induction of anesthesia in emergency laparotomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Active comparator | Drug: Lidocaine, Drug: Propofol, Drug: Succinyl cholinePatients will receive 1 mg/kg lidocaine intravenously (IV) |
| Fentanyl group | Active comparator | Drug: Fentanyl, Drug: Propofol, Drug: Succinyl cholinePatients will receive 1 mcg/kg fentanyl intravenously (IV) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- Both gender
- American Society of Anesthesiologists (ASA) class I-III undergoing emergency laparotomy.
Key exclusion criteria (10 listed)
- Patient refusal
- Severe cardiac morbidities (impaired contractility with ejection fraction < 45%, heart block, arrhythmias, tight valvular lesions)
- Baseline mean arterial pressure <75 mmHg
- Patients on vasopressor infusion,
- Patients with high shock index (heart rate / systolic blood pressure >1)
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 |
|---|---|---|
| LidocaineAfter preoxygenation with 100% oxygen for 3 minutes, the study drug (lidocaine) will be administered. Patients will receive 1 mg/kg lidocaine of 10 mg/mL lidocaine solution (prepared by diluting 5 mL of lidocaine 20% in saline to a total volume of 10 mL) | Drug | Lidocaine group |
| FentanylAfter preoxygenation with 100% oxygen for 3 minutes, the study drug (fentanyl) will be administered. Patients will receive 1 mcg/kg fentanyl of 10 mcg/mL fentanyl solution (prepared by diluting 100 mcg fentanyl in saline to a total volume of 10 mL). | Drug | Fentanyl group |
| PropofolAfter administration of the study drug, all patients will receive 2 mg/kg propofol intravenously | Drug | Fentanyl group, Lidocaine group |
| Succinyl cholineAfter loss of consciousness, 1 mg/kg succinyl choline will be administered over 5 seconds, and tracheal intubation will be done through direct laryngoscopy after 60 seconds. | Drug | Fentanyl group, Lidocaine group |
Primary outcome
Hypotension
Time frame: immediately after induction of anesthesia until 20 minutes after induction of anesthesia
Incidence of post-induction hypotension
3 secondary outcomes
Norepinephrine dose
Time frame: from induction of anesthesia until 20 minutes after skin incision
Heart rate
Time frame: every 2 minutes for 20 minutes after induction of anesthesia
Mean Arterial Pressure
Time frame: every 2 minutes for 20 minutes after induction of anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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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. This study is not recruiting at the moment.
Jehan Elkholy, M.D. study chair
Cairo University
Eman F Ali,, M.D. study director
Cairo University
Kareem MA Nawwar, M.D. study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine, Fentanyl and Propofol in people with Post-induction Hypotension and Lidocaine, 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 5 Mar 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hypotension (time frame: immediately after induction of anesthesia until 20 minutes after induction of anesthesia). 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 Mar 2026.