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

NCT04008433 | Completed

• 1 other identifier: 20190604
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The appearance of intravenous injection pain

  Yes or No

  through study completion, an average of 2 minutes

Secondary Outcomes (2)

• The levels of intravenous injection pain

  through study completion, an average of 2 minutes

• If any adverse memory or pain during the induction of general anesthesia

  Before patients left the postanesthetic care unit (PACU)

Study Arms (1)

Lidocaine pre-intravenous injection

EXPERIMENTAL

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.

Drug: Lidocaine

Interventions

Lidocaine DRUG

Advanced intravenous injection of lidocaine before the propofol injection

Lidocaine pre-intravenous injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, 225012, China

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 5, 2019
• Study Start: November 16, 2018
• Primary Completion: November 16, 2018
• Study Completion: June 13, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

CN (1)