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Clinical Practice of Inhalation Anesthesia With Sevoflurane in China

NCT ID: NCT01715857

Last Updated: 2014-08-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-07-31

Brief Summary

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Until recently, there was a lack of understanding and consensus among Chinese anesthesiologists how they should practice general anesthesia with volatile anesthetics, since there was no standard of inhalation practice. In August 2011, the Anesthesiology branch of the Chinese Medical Association launched the first version of Chinese Consensus of Standard Clinical Practice for Inhalation Anesthesia (Consensus) in order to standardize the practice in China.

The proposed registry is aimed to evaluate the current inhalation practice one year after the Consensus has been released, and related patient outcome. This registry evaluated sevoflurane anesthesia, including screening, induction, maintenance, emergence, and follow-up within 24 hours post-operation.

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Detailed Description

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Conditions

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Anesthesia, General

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Chinese Patients Requiring Surgery with Sevoflurane Anesthesia

Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Man or woman, aged from 18 to 70 years old.
2. American Society of Anesthesiologists (ASA) physical status: I, II and III.
3. Surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA).
4. The type of surgery is either general surgery, or orthopedics, or gynecology.
5. The duration of anesthesia ranges from 1 to 5 hours.

Exclusion Criteria

1. History of clinically significant cardiovascular, pulmonary, renal, hepatic or central nervous system or muscle disease.
2. Known hypersensitivity or history of unusual response to any halogenated anesthetics.
3. Personal or familial history of malignant hyperthermia.
4. Female patients who are either pregnant or breast feeding.
5. General anesthesia is administered with total intravenous anesthesia (TIVA) of propofol or sevoflurane maintenance combined with propofol continuous infusion during maintenance.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yue Kang, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 84317

Beijing, , China

Site Status

Site Reference ID/Investigator# 86755

Beijing, , China

Site Status

Site Reference ID/Investigator# 96155

Beijing, , China

Site Status

Site Reference ID/Investigator# 84320

Beijing, , China

Site Status

Site Reference ID/Investigator# 84316

Beijing, Xicheng District, , China

Site Status

Site Reference ID/Investigator# 84321

Changchun, Jilin, , China

Site Status

Site Reference ID/Investigator# 86754

Changchun, Jilin, , China

Site Status

Site Reference ID/Investigator# 86764

Changsha, Hunan, , China

Site Status

Site Reference ID/Investigator# 86767

Changsha, Hunan, , China

Site Status

Site Reference ID/Investigator# 100206

Chengdu, , China

Site Status

Site Reference ID/Investigator# 86762

Chongqing, , China

Site Status

Site Reference ID/Investigator# 84338

Guangzhou, , China

Site Status

Site Reference ID/Investigator# 106416

Guangzhou, , China

Site Status

Site Reference ID/Investigator# 84337

Guangzhou, , China

Site Status

Site Reference ID/Investigator# 102457

Guangzhou, , China

Site Status

Site Reference ID/Investigator# 84333

Guangzhou, Guangdong, , China

Site Status

Site Reference ID/Investigator# 100095

Guangzhou, Guangdong, , China

Site Status

Site Reference ID/Investigator# 84334

Harbin, Heilongjiang, , China

Site Status

Site Reference ID/Investigator# 86759

Jinan, Shandong, , China

Site Status

Site Reference ID/Investigator# 84318

Kunming, Yunnan, , China

Site Status

Site Reference ID/Investigator# 86757

Kunming, Yunnan, , China

Site Status

Site Reference ID/Investigator# 84336

Lanzhou, Gansu, , China

Site Status

Site Reference ID/Investigator# 84322

Lanzhou, Gansu, , China

Site Status

Site Reference ID/Investigator# 86761

Nanchang, Jiangxi, , China

Site Status

Site Reference ID/Investigator# 102455

Qingdao, , China

Site Status

Site Reference ID/Investigator# 78434

Shanghai, , China

Site Status

Site Reference ID/Investigator# 86073

Shanghai, , China

Site Status

Site Reference ID/Investigator# 84342

Shanghai, , China

Site Status

Site Reference ID/Investigator# 84314

Shenyang, Liao Ning, , China

Site Status

Site Reference ID/Investigator# 84319

Shijiazhuang Hebei, , China

Site Status

Site Reference ID/Investigator# 100207

Tianjin, , China

Site Status

Site Reference ID/Investigator# 95295

Tianjin, , China

Site Status

Site Reference ID/Investigator# 86760

Wuhan, Hubei, , China

Site Status

Site Reference ID/Investigator# 86766

Zhengzhou, Henan, , China

Site Status

Site Reference ID/Investigator# 86763

Zhengzhou, Henan, , China

Site Status

Site Reference ID/Investigator# 86769

Zunyi, Guizhou, , China

Site Status

Countries

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China

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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P13-934

Identifier Type: -

Identifier Source: org_study_id

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