Median Effective Dose of Lidocaine for the Prevention of Pain Caused by the Injection of Propofol Formulated With Medium-/Long-chain Triglycerides

Lidocaine Clinical Trial

Official title:

Median Effective Dose of Lidocaine for the Prevention of Pain Caused by the Injection of Propofol Formulated With Medium-/Long-chain Triglycerides

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008433
• Other study ID #: 20190604
• Status: Completed
• Phase: N/A
• Start date: November 16, 2018
• Est. completion date: June 13, 2019

Study information

• Verified date: January 2020
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Propofol is widely used in general anesthesia induction, but the occurrence of peripheral intravenous pain is relatively high, causing anxiety, fear and other adverse emotions in patients , aggravating the stress response, and even leading to adverse events of cardiovascular system . The use of mediate-long chain fat emulsion propofol partly reduces the incidence of injection pain but patients can still suffer from different degrees of pain. Advanced intravenous injection of lidocaine can alleviate the pain of propofol injection, but its application method and dose are controversial. It is worthy of further discussion on how to select the appropriate dose of advanced intravenous injection of lidocaine to effectively prevent the injection pain of mediate-long chain fat emulsion propofol, and simultaneously avoid the adverse reactions of intravenous lidocaine, thus improving patient satisfaction and perioperative safety. In this study, in order to provide clinical references, sequential method was used to find the median effective dose (ED50) by means of pre-intravenous injection of lidocaine to suppress pain in mediate-long chain fat emulsion propofol injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 13, 2019
• Est. primary completion date: November 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Ages ranged from 18 to 65.

• ASA ? or ? level.

Exclusion Criteria:

• Allergy or contraindication to lidocaine or propofol; required for Central venipuncture catheterization;

• Abnormal liver or kidney function;

• Heavy drinking and long-term use of sedatives, analgesics or anti-anxiety drugs;

• Hearing and language impairment;

• Peripheral vascular disease;

• Severe cardiovascular disease or neurological disorders;

• Failure of one-time peripheral venipuncture;

• Infection of hand or wrist skin.

Related Conditions & MeSH terms

• Injection Pain
• Lidocaine

Intervention

Drug:
• Lidocaine
Advanced intravenous injection of lidocaine before the propofol injection

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The appearance of intravenous injection pain	Yes or No	through study completion, an average of 2 minutes
Secondary	The levels of intravenous injection pain	The intravenous injection pain in this study was divided into the following 5 levels according to its severity: level 0: After repeated questioning, the patient did not feel any abnormal sensation; level 1: upon inquiry, the patient felt swelling at the intravenous injection site; Level 2: Upon inquiry, the patient felt pain and had no body movement reaction (facial pain expression, arm withdrawal, tears, etc.); Level 3: Upon inquiry, the patient had pain and body movement reaction. Or complain of pain without inquiry; Level 4: the patient has a strong reaction and body movement reaction. Level 2 and above is defined as injection pain.	through study completion, an average of 2 minutes
Secondary	If any adverse memory or pain during the induction of general anesthesia	Patients recalled by visual analogue scale (VAS) to assess injection pain level : Mark 0 is painless. Mark 10 is violent pain, The numbers between them was pain of varying degrees.	Before patients left the postanesthetic care unit (PACU)