Perioperative Muscle Relaxant and Postoperative Outcomes
POMPO
Effect of Perioperative Muscle Relaxant Model on Postoperative Outcomes in Chinese Patients
1 other identifier
observational
999
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 17, 2018
CompletedFirst Submitted
Initial submission to the registry
April 27, 2020
CompletedFirst Posted
Study publicly available on registry
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2021
CompletedSeptember 2, 2022
August 1, 2022
3.4 years
April 27, 2020
August 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
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
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
Study Arms (2)
Deep neuro-muscular blockade
Moderate neuro-muscular blockade
Interventions
No response is observed during Train of Four stimulation monitoring during surgery
1 to 2 response is observed during Train of Four stimulation monitoring during surgery
Eligibility Criteria
Patients scheduled for laparoscopic surgery are consecutively screened with inclusion and exclusion criteria.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
First hospital of Beijing University
Beijing, Beijing Municipality, China
Xiehe Hospital of Fujian Medical University
Fuzhou, Fujian, China
First Afiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Tongji Hospital of Tongji Medical School
Wuhan, Hubei, China
Xiehe Hospital of Tongji Medical School
Wuhan, Hubei, China
Ruijin Hospital
Shanghai, Shanghai Municipality, China
Huaxi Hospital
Chengdu, Sichuan, China
General hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
People's Hospital of Jiangsu
Nanjing, China
Related Publications (2)
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.
PMID: 26479510BACKGROUNDTorensma 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.
PMID: 27936214BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 27, 2020
First Posted
May 1, 2020
Study Start
March 17, 2018
Primary Completion
August 12, 2021
Study Completion
August 12, 2021
Last Updated
September 2, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share