Perioperative Muscle Relaxant and Postoperative Outcomes

Postoperative Complications Clinical Trial

— POMPO  

Official title:

Effect of Perioperative Muscle Relaxant Model on Postoperative Outcomes in Chinese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04371588
• Other study ID #: XJH-A-20290110
• Status: Completed
• Start date: March 17, 2018
• Est. completion date: August 12, 2021

Study information

• Verified date: August 2022
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Muscle relaxant is usually needed for surgery. However, the optimal depth of neuro-muscular blockade is still on debate. Deep neuro-muscular blockade may benefit the patients during surgery, but may increase the risk of residual blockade after surgery. Residual blockade has been reported to increase risk of morbidity. In this study, we tend to observe the postoperative outcomes in patients undergoing abdominal surgery under general anesthesia. And to compare the outcomes in patients received different depth of neuro-muscular blockade.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 999
• Est. completion date: August 12, 2021
• Est. primary completion date: August 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age =18 years old

• Body mass <18 kg/m2

• American Society of Anesthesiologists status I-II

• Patients scheduled for elective laparoscopic colorectal or urological surgery

• Patients received general anesthesia and muscle relaxant

• Patients with written informed consent.

Exclusion Criteria:

• Second surgery during the same admission.

• Outpatient surgery

• Retroperitoneal laparoscopic surgery

• Patients scheduled for mechanical ventilation after surgery

• Patients scheduled for muscle relaxant other than rocuronium

• Patients with pregnancy or planned for breeding

• Patients who are involved in other studies

Related Conditions & MeSH terms

• Muscle Hypotonia
• Postoperative Complications

Intervention

Other:
• No Response to Train of Four Stimulation
No response is observed during Train of Four stimulation monitoring during surgery
• 1-2 Response to Train of Four Stimulation
1 to 2 response is observed during Train of Four stimulation monitoring during surgery

Locations

Country	Name	City	State
China	First hospital of Beijing University	Beijing	Beijing
China	Huaxi Hospital	Chengdu	Sichuan
China	Xiehe Hospital of Fujian Medical University	Fuzhou	Fujian
China	People's Hospital of Jiangsu	Nanjing
China	Ruijin Hospital	Shanghai	Shanghai
China	General hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tongji Hospital of Tongji Medical School	Wuhan	Hubei
China	Xiehe Hospital of Tongji Medical School	Wuhan	Hubei
China	First Afiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (2)

Madsen MV, Istre O, Staehr-Rye AK, Springborg HH, Rosenberg J, Lund J, Gätke MR. Postoperative shoulder pain after laparoscopic hysterectomy with deep neuromuscular blockade and low-pressure pneumoperitoneum: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):341-7. doi: 10.1097/EJA.0000000000000360. — View Citation

Torensma B, Martini CH, Boon M, Olofsen E, In 't Veld B, Liem RS, Knook MT, Swank DJ, Dahan A. Deep Neuromuscular Block Improves Surgical Conditions during Bariatric Surgery and Reduces Postoperative Pain: A Randomized Double Blind Controlled Trial. PLoS One. 2016 Dec 9;11(12):e0167907. doi: 10.1371/journal.pone.0167907. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale of pain at rest at 24 hours after surgery	The intensity of pain is reported by the patient by provide a number between 0 and 10. 0 means no pain, and 10 means unbearable pain. Higher score means stronger pain.	from end of surgery to 24 hours after surgery
Primary	Visual Analogue Scale of pain at cough at 24 hours after surgery	The intensity of pain is reported by the patient by provide a number between 0 and 10. 0 means no pain, and 10 means unbearable pain. Higher score means stronger pain.	from end of surgery to 24 hours after surgery
Secondary	Incidence of patients suffering pain at 24 hours after surgery		from end of surgery to 24 hours after surgery
Secondary	Time to flatus		from end of surgery to flatus, on an average of 3 days
Secondary	Time to extubation of the endotracheal tube		from end of surgery to removal of the endotracheal tube, on an average of 15 minutes
Secondary	Incidence of major postoperative complications	Incidence of major postoperative complications (including myocardial ischemia, pulmonary infection, respiratory failure, brain ischemia)	from end of surgery to discharge from the hospital, on an average of 5 days
Secondary	Satisfaction score of the Surgeon to the condition during surgery	The satisfaction of the Surgeon is measured by a scale from 0-10. 0 is for extremely unsatisfied, 10 is for totally satisfied. Higher score means higher satisfaction. The surgeon is asked to give a number between 0 and 10 to describe his satisfaction.	from start of surgery to end of surgery, on an average of 2.5 hours