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Completed

NCT Number: NCT04008433

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

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.

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Key information

Conditions

Lidocaine Injection Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, 225012, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine

Drug

Advanced intravenous injection of lidocaine before the propofol injection

Primary outcomes

  1. The appearance of intravenous injection pain

    Time frame: through study completion, an average of 2 minutes

    Yes or No

Secondary outcomes

  1. The levels of intravenous injection pain

    Time frame: through study completion, an average of 2 minutes

    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.

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

    Time frame: Before 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.

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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