Minimal Effective Concentration of Lidocaine in Propofol Lidocaine Mixture for Relief of Pain on Propofol Injection

The research will be carried out in order to determine the optimal lidocaine concentration in propofol lidocaine mixture to prevent pain on propofol injection during induction of general anesthesia using a modified Dixon's up-and-down method. We hypothesized that focusing on lidocaine concentration and not dose could be more convenient and valuable to alleviate pain with propofol injection.

Patients & methods include assessment of severity of pain on propofol injection using nine concentrations of lidocaine in lidocaine propofol mixture in ASA I&II patients aged 16-60 years with excluxion of patients with history of drug allergy, hepatic or renal impairment, cardiac problems, neurologic deficits or psychiatric disorders.

Demographic data, type and duration of surgery, Time for unconsciousness, volume of propofol-lidocaine mixture used, pain scale during injection, increase in heart rate and/or hand or forearm withdrawal during injection will be recorded and patient satisfaction (will be assessed in the recovery room after regaining consciousness),

Study Overview

• Status: Not yet recruiting
• Conditions: Pain
• Intervention / Treatment: Drug: lidocaine with propofol

Detailed Description

The research will be carried out in order to determine the optimal lidocaine concentration in propofol lidocaine mixture to prevent pain on propofol injection during induction of general anesthesia using a modified Dixon's up-and-down method. We hypothesized that focusing on lidocaine concentration and not dose could be more convenient and valuable to alleviate pain with propofol injection.

Patients & methods include assessment of severity of pain on propofol injection using nine concentrations of lidocaine in in lidocaine propofol mixture in ASA I&II patients aged 18-60 years with exclusion of patients with history of drug allergy, hepatic or renal impairment, cardiac problems, neurologic deficits or psychiatric disorders.

Demographic data, type and duration of surgery, Time for unconsciousness, volume of propofol-lidocaine mixture used, pain scale during injection, increase in heart rate and/or hand or forearm withdrawal during injection, patient satisfaction (will be assessed in the recovery room after regaining consciousness),

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Roshdi Youssef, MD; Phone Number: +966502893485; Email: metwalli@yahoo.com
• Study Contact Backup: Name: Hitham M elsayed, MD; Phone Number: +966581729368; Email: HIMelsayed@iau.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I &II
• Age 18 - 60 years

Exclusion Criteria:

• study drug allergy
• hepatic or renal impairment
• cardiac problem
• neurologic deficits
• psychiatric disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lidocaine with propofol	Drug: lidocaine with propofol; different concentrations of lidocaine added to propofol varying from

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
propofol injection pain	burning pain felt by the participant during injection of propofol according to pain scale including mild, moderate and severe pain degrees	during injection untill patient start loosing conciousness

Collaborators and Investigators

• Sponsor: Imam Abdulrahman Bin Faisal University
• Investigators: Study Director: Alaa Mohammed, MD, King Fahd University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): June 28, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: October 16, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Propofol; Lidocaine
• Other Study ID Numbers: IRB-2020-331-KFUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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