NCT06772727

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

January 3, 2025

Last Update Submit

March 4, 2026

Conditions

Post-induction HypotensionLidocaineOpioidEmergency Laparotomy

Outcome Measures

Primary Outcomes (1)

  • Hypotension

    Incidence of post-induction hypotension

    immediately after induction of anesthesia until 20 minutes after induction of anesthesia

Secondary Outcomes (3)

  • Norepinephrine dose

    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

Study Arms (2)

Lidocaine group

ACTIVE COMPARATOR

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

Drug: LidocaineDrug: PropofolDrug: Succinyl choline

Fentanyl group

ACTIVE COMPARATOR

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

Drug: FentanylDrug: PropofolDrug: Succinyl choline

Interventions

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)

Lidocaine group
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).

Fentanyl group
PropofolDRUG

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

Fentanyl groupLidocaine group
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.

Fentanyl groupLidocaine group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

LidocaineFentanylPropofol

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Jehan Elkholy, M.D.

    Cairo University

    STUDY CHAIR

  • Eman F Ali,, M.D.

    Cairo University

    STUDY DIRECTOR

  • Kareem MA Nawwar, M.D.

    Cairo University

    STUDY DIRECTOR

  • Mohsen M Waheeb, M.D.

    Cairo University

    STUDY DIRECTOR

  • Samar M Abdel Azeim Ghazala, M.Sc.

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 3, 2025

First Posted

January 13, 2025

Study Start

February 1, 2025

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

EG(1)