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Clinical Trials/NCT02017392
NCT02017392
Unknown
Phase 4

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

Third Affiliated Hospital, Sun Yat-Sen University1 site in 1 country2,000 target enrollmentDecember 2013

Overview

Phase
Phase 4
Intervention
Compound Lidocaine Cream
Conditions
Postoperative Agitation of Patients
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Enrollment
2000
Locations
1
Primary Endpoint
Vital signs like blood pressure and heart rates during extubation.
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
April 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Responsible Party
Principal Investigator
Principal Investigator

Yanni Wang

student

Third Affiliated Hospital, Sun Yat-Sen University

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

Arms & Interventions

Compound Lidocaine Cream

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

Intervention: Compound Lidocaine Cream

Outcomes

Primary Outcomes

Vital signs like blood pressure and heart rates during extubation.

Time Frame: an hour

Secondary Outcomes

  • The cough reflex and breath holding during extubation.(an hour)

Study Sites (1)

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