Clinical trial NCT01871064: Residual Curarization and Its Incidence at Tracheal Extubation in China
Official title: Residual Curarization and Its Incidence at Tracheal Extubation in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Residual Curarization
Keywords: Laparotomy
laparoscopic surgery
general anesthesia
Neuromuscular Block
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-06-06
Enrollment: 1571
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults 18 years of age or older scheduled to undergo an elective open abdominal or laparoscopic surgical procedure for an anticipated duration of less than four hours will be approached for participation in the study.

Brief summary: This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios at tracheal extubation when anesthesiologists have determined that full recovery of neuromuscular function has occurred using standard clinical criteria for participants whose non-depolarizing-induced NMB is either not reversed or reversed with an acetylcholinesterase inhibitor administered as per standard routine care.

Detailed description: This is a prospective, multi-site, anesthesiologist and PACU nurse TOF-Watch SX® blinded observational study of surgical patients undergoing elective laparoscopic or open abdominal procedures requiring general anesthesia and non-depolarizing neuromuscular blockade. There are two temporal aspects to the data collection: a prospective data collection in the OR and PACU; and a retrospective chart review one week after hospital discharge.

Eligibility criteria: Inclusion Criteria:

* Age≥18;
* American Society of Anesthesiologists(ASA) class 1-3;
* Scheduled for elective open or laparoscopic abdominal surgery that is anticipated to last less than 4 hours;
* Administration of general anesthesia and ≥ 1 dose of non-depolarizing neuromuscular blockers for endotracheal intubation or maintenance of neuromuscular blockade;
* Planned for extubation to occur in the OR;
* Signed informed consent.

Exclusion Criteria:

* Redo surgery on the same hospital admission;
* Pre-established need or expected to require post-operative mechanical ventilation;
* Conditions, surgical procedures, or participant positioning that may interfere with TOF-Watch SX® operation, calibration, or accuracy;
* Anesthesiologist use of objective neuromuscular monitoring during surgery (e.g. mechanomyography, electromyography or related method);
* Pregnancy;
* Participation in any other clinical trial;
* Member or a family member of the personnel of the investigational or Sponsor staff directly involved with this trial.

Primary outcomes:
measure: Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation
timeFrame: Immediately prior to tracheal extubation in the OR
Secondary outcomes:
measure: Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)
timeFrame: Immediately upon PACU arrival
measure: Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation
timeFrame: Immediately prior to tracheal extubation in the OR
measure: Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU
timeFrame: Immediately upon PACU Arrival
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: ZhuJiang Hospital of Southern Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of HUST
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu Province People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Xi'an
country: China
facility: Xijing Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Urumqi
country: China
facility: Xinjiang Traditional Chinese Medicine Hospital
state: Xinjiang
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: Second Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Tongren Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Chongqing
country: China
facility: First Affiliated Hospital of Chongqing Medical University
city: Shanghai
country: China
facility: Renji Hospital
city: Shanghai
country: China
facility: Ruijin Hospital
city: Shanghai
country: China
facility: Shanghai Cancer Hospital, China
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
Study officials:
affiliation: Peking University First Hospital
name: Xinmin Wu, MD
role: PRINCIPAL_INVESTIGATOR
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