A RCT of Compound Lidocaine Cream to Prevent Postoperative Agitation in Patients With Endotracheal Intubation for GA

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the compound lidocaine cream is effective in preventing postoperative agitation in patients with endotracheal intubation for general anesthesia.

Detailed Description
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This is a randomized controlled study. Some parameters were provided by preliminary test, provided theα=0.05,and β=0.20, the sample size can be estimated to be 2000 by the Open Epi Version 2.Patients will be recruited on the basis of predefined criterias. A researcher will take charge of the recruitment. Participants provide written consent and no financial incentives are provided. They are divided into experimental group and control group randomly. We need to collect their basic information including ages, genders, heights, weights, underlying diseases, surgical procedures and levels classified by ASA. Blood pressure, heart rate and other vital signs during the tube drawing process will be recorded. All the contents needed to be recorded had been compiled into a watch list with detailed instructions for filling in. All the personal information and observation records of participants will be kept in secret and only used for research. Developing standard operating procedure and training all the researchers. A third party will assess the accuracy, completeness and representativeness of registry data. Experimental data will be analysed with the help of statisticians.

Official Title
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A Randomized Controlled Study of Compound Lidocaine Cream to Prevent Postoperative Agitation in Patients With Endotracheal Intubation for General Anesthesia

Conditions
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Postoperative Agitation of Patients

Intervention / Treatment
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* Drug: Compound Lidocaine Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged over 18 selective operation patients with endotracheal intubation for general anesthesia Exclusion Criteria: highly sensitive to local anesthetics of amide derivatives or anything else in compound lidocaine cream congenital or idiopathic methemoglobinemia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compound Lidocaine Cream<br>The cuff of endotracheal tube is covered by 1-2g compound lidocaine cream before the general anesthesia. | Drug: Compound Lidocaine Cream<br>* Compound Lidocaine Cream ,1-2 grams per person.<br>|
| No Intervention: blank control<br>No intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs like blood pressure and heart rates during extubation. |  | an hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cough reflex and breath holding during extubation. |  | an hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative agitation, endotracheal intubation, general anesthesia