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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05165303
• Other study ID #: IRB-2020-331-KFUH
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 1, 2022
• Est. completion date: July 30, 2022

Study information

• Verified date: December 2021
• Source: Imam Abdulrahman Bin Faisal University
• Contact: Roshdi Youssef, MD
• Phone: +966502893485
• Email: metwalli[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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),

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),

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 30, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA I &II

• Age 18 - 60 years

Exclusion Criteria:

• study drug allergy

• hepatic or renal impairment

• cardiac problem

• neurologic deficits

• psychiatric disorders

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• lidocaine with propofol
different concentrations of lidocaine added to propofol varying from

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Imam Abdulrahman Bin Faisal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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