Minimal Effective Concentration of Lidocaine in Propofol... | NCT05165303

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

NCT05165303

Sponsor

Imam Abdulrahman Bin Faisal University

Status

Unknown status

Last Update Posted

Dec 21, 2021Actual

Enrollment

30Estimated

Phase

Phase 4

Conditions

Pain

Interventions

lidocaine with propofol

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Estimated

Primary Completion Date

Jun 28, 2022Estimated

Completion Date

Jul 30, 2022Estimated

First Submitted Date

Oct 16, 2021

First Submission Date that Met QC Criteria

Dec 9, 2021

First Posted Date

Dec 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2021

Last Update Posted Date

Dec 21, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hitham Mohammed Aly Elsayed, Anesthesia consultant, Imam Abdulrahman Bin Faisal UniversityPrincipal Investigator

Lead Sponsor

Imam Abdulrahman Bin Faisal UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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),

Detailed Description

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),

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lidocaine with propofol	Experimental		Drug: lidocaine with propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lidocaine with propofol	Drug	different concentrations of lidocaine added to propofol varying from	lidocaine with propofol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I &II
Age 18 - 60 years

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Roshdi Youssef, MD	Contact	+966502893485		metwalli@yahoo.com
Hitham M elsayed, MD	Contact	+966581729368		HIMelsayed@iau.edu.sa

Overall Officials

Name	Affiliation	Role
Alaa Mohammed, MD	King Fahd university hospital	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine
D015742	Propofol

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

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.

Who Masked

Not provided