Perioperative Muscle Relaxant and Postoperative Outcomes

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Complications

Intervention / Treatment
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* Other: No Response to Train of Four Stimulation
* Other: 1-2 Response to Train of Four Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Deep neuro-muscular blockade<br> | Other: No Response to Train of Four Stimulation<br>* No response is observed during Train of Four stimulation monitoring during surgery<br>|
| Moderate neuro-muscular blockade<br> | Other: 1-2 Response to Train of Four Stimulation<br>* 1 to 2 response is observed during Train of Four stimulation monitoring during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of patients suffering pain at 24 hours after surgery |  | from end of surgery to 24 hours after surgery | 
| Time to flatus |  | from end of surgery to flatus, on an average of 3 days | 
| Time to extubation of the endotracheal tube |  | from end of surgery to removal of the endotracheal tube, on an average of 15 minutes | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle relaxant, general anesthesia, Chinese patient