Trial intelligence / Profile preview

Lidocaine vs Fentanyl for Anesthesia Induction in Hypertensive Adults

NCT06557473Phase 4

Key facts

Status
Completed
Start
Apr 2023
Primary completion
May 2024
Countries
1
Sponsor
Theodor Bilharz Research Institute
Modality
Small Molecules
Conditions
hypotension
01

Overview

Phase 4, randomised, double-blind trial of Lidocaine Hydrochloride Injection, without epinephrine in hypotension (2 arms), sponsored by Theodor Bilharz Research Institute. Primary endpoint: Mean Arterial Pressure. Started Apr 2023; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Lidocaine Group

    Lidocaine 1.5 mg/kg + Propofol 2 mg/kg + Atracurium 0.5 mg

  • Fentanyl Group

    Fentanyl 2 µg/kg + Propofol 2 mg/kg + Atracurium 0.5 mg

03

Who it enrols

Hypertensive adults (ASA II) aged 18-60 undergoing elective non-cardiac surgery, with controlled hypertension (>5 years duration). Excludes obese patients (BMI >= 35), uncontrolled hypertension, pregnancy, drug abuse, and difficult intubation.

04

Endpoints

Primary

  • Mean Arterial Pressure

Secondary

  • Number of hypotensive episodes

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