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CompletedNCT06772727Updated Mar 5, 2026

Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy

A Phase 4 interventional study of Lidocaine and Fentanyl in Post-induction Hypotension, Lidocaine and Opioid, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Cairo University · Phase 4, Interventional, and Other

Phase
Phase 4
Study type
Interventional
Enrollment
149
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Post-induction Hypotension
  • Lidocaine
  • Opioid
  • Emergency Laparotomy
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adult patients
  2. Both gender
  3. American Society of Anesthesiologists (ASA) class I-III undergoing emergency laparotomy.

Exclusion criteria

Exclusion Criteria:

  1. Patient refusal
  2. Severe cardiac morbidities (impaired contractility with ejection fraction \< 45%, heart block, arrhythmias, tight valvular lesions)
  3. Baseline mean arterial pressure \<75 mmHg
  4. Patients on vasopressor infusion,
  5. Patients with high shock index (heart rate / systolic blood pressure >1)
  6. Pregnant or lactating women,
  7. Allergy of any of the study drugs
  8. Uncontrolled hypertension
  9. Opioid drug abusers
  10. Patients with increased intracranial tension
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
149 participants (actual)

Study arms

  • Active comparator
    Lidocaine group

    Patients will receive 1 mg/kg lidocaine intravenously (IV)

    Drug: Lidocaine · Drug: Propofol · Drug: Succinyl choline

  • Active comparator
    Fentanyl group

    Patients will receive 1 mcg/kg fentanyl intravenously (IV)

    Drug: Fentanyl · Drug: Propofol · Drug: Succinyl choline

Interventions

  • DrugLidocaine

    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)

  • DrugFentanyl

    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).

  • DrugPropofol

    After administration of the study drug, all patients will receive 2 mg/kg propofol intravenously

  • DrugSuccinyl choline

    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.

06

What researchers measure

Primary outcomes

  1. Hypotension

    Incidence of post-induction hypotension

    Time frame: immediately after induction of anesthesia until 20 minutes after induction of anesthesia

Secondary outcomes

  1. Norepinephrine dose

    Total norepinephrine dose during the period from induction of anesthesia until 20-minutes after intubation or skin incision

    Time frame: from induction of anesthesia until 20 minutes after skin incision

  2. Heart rate

    Time frame: every 2 minutes for 20 minutes after induction of anesthesia

  3. Mean Arterial Pressure

    Time frame: every 2 minutes for 20 minutes after induction of anesthesia

07

Study locations

1 site
  • Faculty of Medicine, Cairo University
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06772727
Lead sponsor
Cairo University
Responsible party
Kareem Mohammed Assem Nawwar (Lecturer, Cairo University) — Principal investigator
First posted
Jan 13, 2025
Start date
Feb 1, 2025
Primary completion
Oct 30, 2025
Completion
Oct 30, 2025
Last update
Mar 5, 2026

Study contacts

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
Mohsen M Waheeb, M.D.
study director · Cairo University
Samar M Abdel Azeim Ghazala, M.Sc.
principal investigator · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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