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Completed

NCT Number: NCT04371588

Perioperative Muscle Relaxant and Postoperative Outcomes

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.

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Key information

Conditions

Postoperative Complications Muscle Hypotonia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First hospital of Beijing University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Response to Train of Four Stimulation

Other

No response is observed during Train of Four stimulation monitoring during surgery

1-2 Response to Train of Four Stimulation

Other

1 to 2 response is observed during Train of Four stimulation monitoring during surgery

Primary outcomes

  1. Visual Analogue Scale of pain at rest at 24 hours after surgery

    Time frame: 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.

  2. Visual Analogue Scale of pain at cough at 24 hours after surgery

    Time frame: 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 outcomes

  1. Incidence of patients suffering pain at 24 hours after surgery

    Time frame: from end of surgery to 24 hours after surgery

  2. Time to flatus

    Time frame: from end of surgery to flatus, on an average of 3 days

  3. Time to extubation of the endotracheal tube

    Time frame: from end of surgery to removal of the endotracheal tube, on an average of 15 minutes

  4. Incidence of major postoperative complications

    Time frame: 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)

  5. Satisfaction score of the Surgeon to the condition during surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Acronym: POMPO

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 1, 2020
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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