Clinical trial NCT04371588: Perioperative Muscle Relaxant and Postoperative Outcomes
Official title: Effect of Perioperative Muscle Relaxant Model on Postoperative Outcomes in Chinese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Keywords: muscle relaxant
general anesthesia
Chinese patient
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 999
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for laparoscopic surgery are consecutively screened with inclusion and exclusion criteria.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale of pain at rest at 24 hours after surgery
timeFrame: from end of surgery to 24 hours after surgery
measure: Visual Analogue Scale of pain at cough at 24 hours after surgery
timeFrame: from end of surgery to 24 hours after surgery
Secondary outcomes:
measure: Incidence of patients suffering pain at 24 hours after surgery
timeFrame: from end of surgery to 24 hours after surgery
measure: Time to flatus
timeFrame: from end of surgery to flatus, on an average of 3 days
measure: Time to extubation of the endotracheal tube
timeFrame: from end of surgery to removal of the endotracheal tube, on an average of 15 minutes
measure: Incidence of major postoperative complications
timeFrame: from end of surgery to discharge from the hospital, on an average of 5 days
measure: Satisfaction score of the Surgeon to the condition during surgery
timeFrame: from start of surgery to end of surgery, on an average of 2.5 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: First hospital of Beijing University
state: Beijing
city: Fuzhou
country: China
facility: Xiehe Hospital of Fujian Medical University
state: Fujian
city: Zhengzhou
country: China
facility: First Afiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical School
state: Hubei
city: Wuhan
country: China
facility: Xiehe Hospital of Tongji Medical School
state: Hubei
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
city: Chengdu
country: China
facility: Huaxi Hospital
state: Sichuan
city: Tianjin
country: China
facility: General hospital of Tianjin Medical University
state: Tianjin
city: Nanjing
country: China
facility: People's Hospital of Jiangsu
Study officials:
References:
citation: Madsen MV, Istre O, Staehr-Rye AK, Springborg HH, Rosenberg J, Lund J, Gatke 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.
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.