Effects of Intravenous Lidocaine on ED50, ED95 and NTI Values of Propofol Induced Unconsciousness

Study Overview
=================
Brief Summary
-----------------
The effect of intravenous lidocaine on ED50 and ED95 of propofol, which causes unconsciousness, is unclear. In addition, it is not clear whether the depth of anesthesia induced by propofol changes when lidocaine is used in combination. Therefore, the purpose of this study was to study the effects of intravenous lidocaine on ED50, ED95 and NTI values of propofol induced unconsciousness .

Detailed Description
-----------------
Intravenous lidocaine has many advantages in perioperative period, in addition to reducing the amount of opioids and propofol, thus reducing the incidence of adverse reactions caused by them, it also has the effect on organ protection, can shorten the length of hospital stay, and promote postoperative recovery. The effect of intravenous lidocaine on ED50 and ED95 of propofol, which causes unconsciousness, is unclear. In addition, it is not clear whether the depth of anesthesia induced by propofol changes when lidocaine is used in combination. Therefore, the purpose of this study was to study the effects of intravenous lidocaine on ED50, ED95 and NTI values of propofol induced unconsciousness .

Official Title
-----------------
Effects of Intravenous Lidocaine on ED50, ED95 and NTI Values of Propofol Induced Unconsciousness

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Drug: Lidocaine
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The informed consent is signed Aged 18 to 65 years old ASA is rated from I to II Body mass index ranged from 18.5 to 24.9 kg/m2 Exclusion Criteria: Unwilling to sign informed consent or refuse to participate in the study Patients with serious arrhythmia and organic heart disease before surgery Sedative and analgesic drugs were taken within 1 week before surgery Lidocaine allergy Patients with mental and neurological diseases Patients with difficult airway People with hearing impairment

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LP group<br>The experimental group received 1.5 mg/kg lidocaine intravenously,after 90s, the corresponding dose of propofol was injected intravenously at 30mg/kg/h, and to observe Whether consciousness disappears or not，recording NTI values, heart rate, oxygen saturation, mean arterial pressure and drug side effects in the baseline state, 90s after lidocaine administration, 60s and 120s after propofol administration | Drug: Lidocaine<br>* The experimental group was injected with lidocaine 1.5mg/kg, and propofol was pumped intravenously at 90s after lidocaine injection.The dose of propofol was further set according to groups. The heart rate, mean arterial pressure, pulse oxygen saturation and NTI values of subjects were recorded in tne basic state,during the 90s after lidocaine administration, 60s after propofol administration and consciousness loss.The control group simply replaced lidocaine with equal volume normal saline<br>|
| Placebo Comparator: P group<br>Replace lidocaine with equal volume normal saline,Others are the same as the experimental group. | Drug: Normal saline<br>* Normal saline<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with loss of consciousness | Effects of intravenous lidocaine on ED50 and ED95 of propofol induced unconsciousness | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of intravenous lidocaine on NTI values of propofol induced unconsciousness | The NTI values at T1,T2,T3 and T4 were recorded and statistically analyzed | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ED50, ED95, intravinious lidocaine, propofol, NTI