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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04008433
Enrollment
31
Registered
2019-07-05
Start date
2018-11-16
Completion date
2019-06-13
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injection Pain, Lidocaine

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.

Interventions

DRUGLidocaine

Advanced intravenous injection of lidocaine before the propofol injection

Sponsors

Yangzhou University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The appearance of intravenous injection painthrough study completion, an average of 2 minutesYes or No

Secondary

MeasureTime frameDescription
The levels of intravenous injection painthrough study completion, an average of 2 minutesThe 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.
If any adverse memory or pain during the induction of general anesthesiaBefore patients left the postanesthetic care unit (PACU)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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026