Effect of Intravenous Lidocaine on Propofol Requirements

Study Overview
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Brief Summary
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Lidocaine, an amide local anesthetic, has advantages of low price and easily obtaining. Intravenous lidocaine (IVL)initially has been used in the treatment of arrhythmia. It was demonstrated that IVL had analgesic effect, especially in colorectal surgery, but remained controversy in other types of surgeries. Other beneficial effects, such as prevention of hyperalgesia and propofol-induced injection pain, reduction of incidence of postoperative ileus and nausea and vomiting and anti-inflammatory also were proposed.

Detailed Description
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The most frequent drugs for procedural sedation and analgesia are propofol, benzodiazepines and opioids. However, these drugs may cause respiratory depression and circulatory instability. Combination will increase the risk of hypoxia and apnea. In China, most anesthesia for hysteroscopy and gastroenteroscopy is procedural sedation and analgesia(PAS) provided by anesthetists. Foester et,al. have been tested that IVL could significantly reduce propofol requirements 、postoperative pain and fatigue scores in colonoscopy. Chen,et,al. find the same effect of IVL in elderly. However, there is no research reporting IVL used in hysteroscopy and diagnostic curettage. So, our main objective is to evaluate the effect of intravenous lidocaine on propofol requirements in patients undergoing hysteroscopy and diagnostic curettage.

Official Title
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The Effect of Intravenous Lidocaine on Propofol Requirements in Patients Undergoing Hysteroscopy and Diagnostic Curettage

Conditions
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Analgesia

Intervention / Treatment
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* Drug: Lidocaine IV
* Drug: 0.9% normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent hysteroscopy and diagnostic curettage, American Society of Anesthesiologist' physical status 1-2, BMI 18.5-24.9 kg/m2, Exclusion Criteria: Patients with known allergy to lidocaine or other local anesthetics, taken sedatives and analgesics within 1 week before surgery, mental and neurological diseases, hearing impairment, unwilling to sign informed consent or participate in the study, serious arrhythmia and organic heart disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Lidocaine<br>20 eligible patients are received 1.5mg/kg 1%lidocaine intravenously over 30-60s. Then, 4mg/kg/h lidocaine infused intravenously until end of procedure. | Drug: Lidocaine IV<br>* A bolos of 1.5mg/kg lidocaine will be administered before induction. Then, infusion of 4mg/kg/h lidocaine will maintain during procedure.<br>|
| Placebo Comparator: Group Control<br>2020 eligible patients are received equal 0.9% normal saline. | Drug: 0.9% normal saline<br>* 0.9% normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Propofol Requirements | propofol requirements at loss of conciousness and supplemental requirements during procedure | from loss of conciousness to end of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Assessed pain score using 0-10 cm VAS | immediately, 15 min, 30 min in PACU | 
| Fatigue score | Assessed fatigue score using 0-10 cm VAS | immediately, 15 min, 30 min in PACU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravenous lidocaine, propofol, pain score, fatigue score, dose