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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04008433
Other study ID # 20190604
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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