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

NCT ID: NCT02017392

Last Updated: 2013-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-04-30

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.

Conditions

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Postoperative Agitation of Patients

Keywords

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postoperative agitation endotracheal intubation general anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Compound Lidocaine Cream

The cuff of endotracheal tube is covered by 1-2g compound lidocaine cream before the general anesthesia.

Group Type EXPERIMENTAL

Compound Lidocaine Cream

Intervention Type DRUG

Compound Lidocaine Cream ,1-2 grams per person.

blank control

No intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Compound Lidocaine Cream

Compound Lidocaine Cream ,1-2 grams per person.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Yanni Wang

student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xun Liu, Associate Professor

Role: STUDY_CHAIR

Third Affiliated Hospital, Sun Yat-Sen University

Locations

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The third affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Xun Liu, Associate Professor

Role: CONTACT

Phone: 13711692006

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 19151306 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19151049 (View on PubMed)

Lv L, Yan L, Liu X, Chen M. Effectiveness of lidocaine/prilocaine cream on cardiovascular reactions from endotracheal intubation and cough events during recovery period of older patients under general anesthesia: prospective, randomized placebo-controlled study. BMC Geriatr. 2020 May 4;20(1):157. doi: 10.1186/s12877-020-01567-y.

Reference Type DERIVED
PMID: 32366224 (View on PubMed)

Other Identifiers

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[2013]2-85

Identifier Type: -

Identifier Source: org_study_id