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NCT Number: NCT06772727

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

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.

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Key information

Conditions

Post-Induction Hypotension Emergency Laparotomy Lidocaine Opioid

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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,
  • Allergy of any of the study drugs
  • Uncontrolled hypertension
  • Opioid drug abusers
  • Patients with increased intracranial tension

Treatment and study plan

Lidocaine

Drug

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)

Fentanyl

Drug

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).

Propofol

Drug

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

Succinyl choline

Drug

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.

Primary outcomes

  1. Hypotension

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

    Incidence of post-induction hypotension

Secondary outcomes

  1. Norepinephrine dose

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

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparison of Hemodynamic Effect of Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy: a Randomized Controlled Trial.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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