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

NCT ID: NCT05165303

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-07-30

Brief Summary

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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),

Detailed Description

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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),

Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

clinical trial with a single arm
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Mixtures of propofol, lidocaine and saline will be prepared by an anesthetist who is not involved in the study team, participants, investigator and anesthesia care giver will be blinded for the lidocaine concentration used.

Study Groups

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lidocaine with propofol

Group Type EXPERIMENTAL

lidocaine with propofol

Intervention Type DRUG

different concentrations of lidocaine added to propofol varying from

Interventions

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lidocaine with propofol

different concentrations of lidocaine added to propofol varying from

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA I \&II
* Age 18 - 60 years

Exclusion Criteria

* study drug allergy
* hepatic or renal impairment
* cardiac problem
* neurologic deficits
* psychiatric disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role lead

Responsible Party

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Hitham Mohammed Aly Elsayed

Anesthesia consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alaa Mohammed, MD

Role: STUDY_DIRECTOR

King Fahd university hospital

Central Contacts

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Roshdi Youssef, MD

Role: CONTACT

Phone: +966502893485

Email: [email protected]

Hitham M elsayed, MD

Role: CONTACT

Phone: +966581729368

Email: [email protected]

Other Identifiers

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IRB-2020-331-KFUH

Identifier Type: -

Identifier Source: org_study_id