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

Primary Purpose

Postoperative Agitation of Patients

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Compound Lidocaine Cream
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Agitation of Patients focused on measuring postoperative agitation, endotracheal intubation, general anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The third affiliated hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Compound Lidocaine Cream

blank control

Arm Description

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

No intervention.

Outcomes

Primary Outcome Measures

Vital signs like blood pressure and heart rates during extubation.

Secondary Outcome Measures

The cough reflex and breath holding during extubation.

Full Information

First Posted
December 16, 2013
Last Updated
December 16, 2013
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02017392
Brief Title
A RCT of Compound Lidocaine Cream to Prevent Postoperative Agitation in Patients With Endotracheal Intubation for GA
Official Title
A Randomized Controlled Study of Compound Lidocaine Cream to Prevent Postoperative Agitation in Patients With Endotracheal Intubation for General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Agitation of Patients
Keywords
postoperative agitation, endotracheal intubation, general anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Compound Lidocaine Cream
Arm Type
Experimental
Arm Description
The cuff of endotracheal tube is covered by 1-2g compound lidocaine cream before the general anesthesia.
Arm Title
blank control
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Drug
Intervention Name(s)
Compound Lidocaine Cream
Intervention Description
Compound Lidocaine Cream ,1-2 grams per person.
Primary Outcome Measure Information:
Title
Vital signs like blood pressure and heart rates during extubation.
Time Frame
an hour
Secondary Outcome Measure Information:
Title
The cough reflex and breath holding during extubation.
Time Frame
an hour
Other Pre-specified Outcome Measures:
Title
Application of antihypertensive drugs
Time Frame
an hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xun Liu, Associate Professor
Phone
13711692006
Email
naturestyle@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xun Liu, Associate Professor
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
The third affiliated hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19151306
Citation
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.
Results Reference
background
PubMed Identifier
19151049
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.
Results Reference
background
PubMed Identifier
32366224
Citation
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. Erratum In: BMC Geriatr. 2020 Sep 11;20(1):344.
Results Reference
derived

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

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