POMPO: Perioperative Muscle Relaxant and Postoperative Outcomes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Deep neuro-muscular blockade
|
Other: No Response to Train of Four Stimulation
No response is observed during Train of Four stimulation monitoring during surgery
|
| Moderate neuro-muscular blockade
|
Other: 1-2 Response to Train of Four Stimulation
1 to 2 response is observed during Train of Four stimulation monitoring during surgery
|
Outcome Measures
Primary Outcome Measures
- Visual Analogue Scale of pain at rest at 24 hours after surgery [from end of surgery to 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.
- Visual Analogue Scale of pain at cough at 24 hours after surgery [from end of surgery to 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.
Secondary Outcome Measures
- 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 [from end of surgery to discharge from the hospital, on an average of 5 days]
Incidence of major postoperative complications (including myocardial ischemia, pulmonary infection, respiratory failure, brain ischemia)
- Satisfaction score of the Surgeon to the condition during surgery [from start of surgery to end of surgery, on an average of 2.5 hours]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥18 years old
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Body mass <18 kg/m2
-
American Society of Anesthesiologists status I-II
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Patients scheduled for elective laparoscopic colorectal or urological surgery
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Patients received general anesthesia and muscle relaxant
-
Patients with written informed consent.
Exclusion Criteria:
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Second surgery during the same admission.
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Outpatient surgery
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Retroperitoneal laparoscopic surgery
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Patients scheduled for mechanical ventilation after surgery
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Patients scheduled for muscle relaxant other than rocuronium
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Patients with pregnancy or planned for breeding
-
Patients who are involved in other studies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Afiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China | 450052 |
| 2 | People's Hospital of Jiangsu | Nanjing | China |
Sponsors and Collaborators
- Air Force Military Medical University, China
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- XJH-A-20290110