Perioperative Muscle Relaxant and Postoperative Outcomes (POMPO)

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications
• Intervention / Treatment: Other: No Response to Train of Four Stimulation; Other: 1-2 Response to Train of Four Stimulation

• Study Type: Observational
• Enrollment (Actual): 999

Contacts and Locations

Study Locations

• China
  • Nanjing, China
    • People's Hospital of Jiangsu
  • Beijing
    • Beijing, Beijing, China
      • First hospital of Beijing University
  • Fujian
    • Fuzhou, Fujian, China
      • Xiehe Hospital of Fujian Medical University
  • Henan
    • Zhengzhou, Henan, China, 450052
      • First Afiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China
      • Tongji Hospital of Tongji Medical School
    • Wuhan, Hubei, China
      • Xiehe Hospital of Tongji Medical School
  • Shanghai
    • Shanghai, Shanghai, China
      • Ruijin Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • HuaXi hospital
  • Tianjin
    • Tianjin, Tianjin, China
      • General Hospital of Tianjin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients scheduled for laparoscopic surgery are consecutively screened with inclusion and exclusion criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 17, 2018
• Primary Completion (ACTUAL): August 12, 2021
• Study Completion (ACTUAL): August 12, 2021

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (ACTUAL): May 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: general anesthesia; muscle relaxant; Chinese patient
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Postoperative Complications; Muscle Hypotonia
• Other Study ID Numbers: XJH-A-20290110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No