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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02017392
Enrollment
2000
Registered
2013-12-20
Start date
2013-12-31
Completion date
2014-04-30
Last updated
2013-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Agitation of Patients

Keywords

postoperative agitation, endotracheal intubation, general anesthesia

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.

Interventions

DRUGCompound Lidocaine Cream

Compound Lidocaine Cream ,1-2 grams per person.

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Vital signs like blood pressure and heart rates during extubation.an hour

Secondary

MeasureTime frame
The cough reflex and breath holding during extubation.an hour

Other

MeasureTime frame
Application of antihypertensive drugsan hour

Countries

China

Contacts

Primary ContactXun Liu, Associate Professor
naturestyle@163.com13711692006

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026