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

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.

Study Overview

• Status: Completed
• Conditions: Emergency Laparotomy; Lidocaine; Post-induction Hypotension; Opioid
• Intervention / Treatment: Drug: Lidocaine; Drug: Propofol; Drug: Succinyl choline; Drug: Fentanyl

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Medicine, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine group; Patients will receive 1 mg/kg lidocaine intravenously (IV)	Drug: Lidocaine; 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); Drug: Propofol; After administration of the study drug, all patients will receive 2 mg/kg propofol intravenously; Drug: Succinyl 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.
Active Comparator: Fentanyl group; Patients will receive 1 mcg/kg fentanyl intravenously (IV)	Drug: Propofol; After administration of the study drug, all patients will receive 2 mg/kg propofol intravenously; Drug: Succinyl 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.; Drug: Fentanyl; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypotension	Incidence of post-induction hypotension	immediately after induction of anesthesia until 20 minutes after induction of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Norepinephrine dose	Total norepinephrine dose during the period from induction of anesthesia until 20-minutes after intubation or skin incision	from induction of anesthesia until 20 minutes after skin incision
Heart rate		every 2 minutes for 20 minutes after induction of anesthesia
Mean Arterial Pressure		every 2 minutes for 20 minutes after induction of anesthesia

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Jehan Elkholy, M.D., Cairo University; Study Director: Kareem MA Nawwar, M.D., Cairo University; Study Director: Eman F Ali,, M.D., Cairo University; Study Director: Mohsen M Waheeb, M.D., Cairo University; Principal Investigator: Samar M Abdel Azeim Ghazala, M.Sc., Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: January 3, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Disease Attributes; Emergencies; Hypotension; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Piperidines; Phenols; Benzene Derivatives; Lidocaine; Propofol; Fentanyl
• Other Study ID Numbers: MD-265-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No