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

Phase 4

• Conditions: Postoperative Agitation of Patients
• Interventions: Drug: Compound Lidocaine Cream

• Registration Number: NCT02017392
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2013-12
• Study Start: 2013-12
• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2013-12-16
• Last Update Submitted: 2013-12-16
• Study First Posted: 2013-12-20
• Last Update Posted: 2013-12-20
• Primary Completion: 2014-03
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compound Lidocaine Cream	Compound Lidocaine Cream	The cuff of endotracheal tube is covered by 1-2g compound lidocaine cream before the general anesthesia.

Primary Outcome Measures

Name	Time	Method
Vital signs like blood pressure and heart rates during extubation.	an hour

Secondary Outcome Measures

Name	Time	Method
The cough reflex and breath holding during extubation.	an hour

Trial Locations

Locations (1)

The third affiliated hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China