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

Sun Yat-sen University

Status and phase: Unknown; Phase 4

Conditions: Postoperative Agitation of Patients

Treatments: Drug: Compound Lidocaine Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT02017392

[2013]2-85

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,000 participants in 2 patient groups

Compound Lidocaine Cream

Experimental group

Description:

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

Treatment:

Drug: Compound Lidocaine Cream

blank control

No Intervention group

Description:

No intervention.