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

NCT ID: NCT04008433

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-16
• Study Completion Date: 2019-06-13

Brief 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.

Conditions

Lidocaine; Injection Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lidocaine pre-intravenous injection

The initial dose of lidocaine for pre-injection was set at 0.5mg /kg according to previous literature and preliminary test results. The dose of lidocaine was according to the patients' pain level. If there is no pain (negative reaction), the dose of lidocaine in the next patient will be reduced until the patient has pain. If there is pain (positive reaction), the dose of lidocaine will be increased in the next patient until the patient is painless.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

Advanced intravenous injection of lidocaine before the propofol injection

Interventions

Lidocaine

Advanced intravenous injection of lidocaine before the propofol injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Ages ranged from 18 to 65.
• ASA Ⅰ or Ⅱ 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yangzhou University

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Zhang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Countries

China

Other Identifiers

20190604

Identifier Type: -

Identifier Source: org_study_id