Residual Curarization and Its Incidence at Tracheal Extubation in China
- Conditions
- Residual Curarization
- Registration Number
- NCT01871064
- Lead Sponsor
- Xinmin Wu
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1571
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation Immediately prior to tracheal extubation in the OR Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollices muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of \<0.9 is indicative of residual NMB.
- Secondary Outcome Measures
Name Time Method 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 Immediately upon PACU Arrival Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollices muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB.
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 Immediately prior to tracheal extubation in the OR Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollices muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB
Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU) Immediately upon PACU arrival Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollices muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of \<0.9 is indicative of residual NMB.
Trial Locations
- Locations (32)
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Tongji Hospital, Tongji Medical College of HUST
🇨🇳Wuhan, Hubei, China
Wuhan Union Hospital
🇨🇳Wuhan, Hubei, China
China-Japan Union Hospital of Jilin University
🇨🇳Changchun, Jilin, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Xinjiang Traditional Chinese Medicine Hospital
🇨🇳Urumqi, Xinjiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
Renji Hospital
🇨🇳Shanghai, China
Ruijin Hospital
🇨🇳Shanghai, China
ZhuJiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
Northern Jiangsu Province People's Hospital
🇨🇳Yangzhou, Jiangsu, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Xijing Hospital
🇨🇳Xi'an, Shanxi, China
First Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Second Affiliated Hospital of Wenzhou Medical College
🇨🇳Wenzhou, Zhejiang, China
Peking University First Hospital
🇨🇳Beijing, China
Beijing Tongren Hospital
🇨🇳Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
Peking University Third Hospital
🇨🇳Beijing, China
First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
Shanghai Cancer Hospital, China
🇨🇳Shanghai, China
Shanghai First People's Hospital
🇨🇳Shanghai, China
Shanghai Zhongshan Hospital
🇨🇳Shanghai, China