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

Postoperative Agitation of Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02017392
• Other study ID #: [2013]2-85
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 16, 2013
• Last updated: December 16, 2013
• Start date: December 2013
• Est. completion date: April 2014

Study information

• Verified date: December 2013
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Xun Liu, Associate Professor
• Phone: 13711692006
• Email: naturestyle[@]163.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Agitation of Patients
• Psychomotor Agitation

Intervention

Drug:
• Compound Lidocaine Cream
Compound Lidocaine Cream ,1-2 grams per person.

Locations

Country	Name	City	State
China	The third affiliated hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

Batai I, Bogar L, Juhasz V, Batai R, Kerenyi M. A comparison of the antimicrobial property of lidocaine/prilocaine cream (EMLA) and an alcohol-based disinfectant on intact human skin flora. Anesth Analg. 2009 Feb;108(2):666-8. doi: 10.1213/ane.0b013e31818f887e. — View Citation

Sawyer J, Febbraro S, Masud S, Ashburn MA, Campbell JC. Heated lidocaine/tetracaine patch (Synera, Rapydan) compared with lidocaine/prilocaine cream (EMLA) for topical anaesthesia before vascular access. Br J Anaesth. 2009 Feb;102(2):210-5. doi: 10.1093/bja/aen364. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Application of antihypertensive drugs		an hour	Yes
Primary	Vital signs like blood pressure and heart rates during extubation.		an hour	Yes
Secondary	The cough reflex and breath holding during extubation.		an hour	Yes