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

NCT05165303 | Unknown Phase 4 DMC

• 1 other identifier: IRB-2020-331-KFUH
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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),

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

lidocaine with propofol

EXPERIMENTAL

Drug: lidocaine with propofol

Interventions

lidocaine with propofol DRUG

different concentrations of lidocaine added to propofol varying from

lidocaine with propofol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I \&II
• Age 18 - 60 years

You may not qualify if:

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

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Propofol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Alaa Mohammed, MD

  King Fahd university hospital

  STUDY DIRECTOR

Central Study Contacts

Roshdi Youssef, MD

CONTACT

+966502893485; metwalli@yahoo.com

Hitham M elsayed, MD

CONTACT

+966581729368; HIMelsayed@iau.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia consultant

Model Details: clinical trial with a single arm

Study Record Dates

• First Submitted: October 16, 2021
• First Posted: December 21, 2021
• Study Start: March 1, 2022
• Primary Completion: June 28, 2022
• Study Completion: July 30, 2022
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share