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Combining Diaphragmatic Ultrasound with Acceleromyography (TOF-Watch) Monitor in Patients with General Anesthesia: a Clinical Application Study

Combining Diaphragmatic Ultrasound with Acceleromyography (TOF-Watch) Monitor in Patients with General Anesthesia: a Clinical Application Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024270
Enrollment
Unknown
Registered
2019-07-04
Start date
2021-10-01
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Residual neuromuscular block after general anesthesia

Interventions

ultrasonography group:TOF-Watch neuromuscular monitoring during operation
ultrasound monitoring of diaphragm thickness fraction rate to guide patients after extubation
neuromuscular monitor group:full neuromuscular monitoring
tradition experience group:experience guidance

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who underwent elective thyroid cancer radical surgery were expected to have anesthesia time of 1.5h ~ 4h. 2. After surgery, neostigmine is used to antagonize the residual muscle relaxant effect of non-depolarizing muscle relaxants; 3. Aged 18 to 65 years, male or female; 4. ASA rating: Level I - Level II; 5. 18kg/m2 <= BMI <= 27.9 kg/m2; 6. Voluntary signing of informed consent; 7. Non-lactating women, women of childbearing age must have a negative pregnancy test.

Exclusion criteria

Exclusion criteria: 1. A patient who is allergic to cholinergic drugs and their components; 2. Patients with glaucoma, hyperthyroidism, and body temperature >38 degree C; 3. Patients with severe cardiovascular and cerebrovascular diseases, such as coronary heart disease, congestive heart failure, severe arrhythmia (such as atrial flutter, atrial fibrillation, II-III atrioventricular block, etc.), myocardial infarction within 6 months, Stroke, transient cerebral ischemia, etc.; 4. Hypertensive patients who are not satisfactorily controlled, ie, resting systolic blood pressure >= 140mmHg, and/or diastolic blood pressure >= 90 mmHg; hypotensive patients, ie resting systolic blood pressure = 2 x ULN, or TBIL >= 2 x ULN; 8. Abnormal renal function, BUN and/or Ur >= 1.5 x ULN, or Cr exceeds the upper limit of normal; 9. Patients with abnormal blood K+ and Ca2+ before surgery; 10. Patients who are influencing cholinergic drugs or anticholinergic agents (such as phenothiazines, anti-Parkinson's drugs, tricyclic antidepressants) are being used; 11. A patient who is acting on an adrenergic receptor drug is being used; 12. The muscle lesion monitoring site has a history of surgery or trauma within 3 months; 13. Have been allergic to non-depolarizing muscle relaxants in the past; 14. There are contraindications to neostigmine, such as bronchial asthma, arrhythmia, especially atrioventricular block, myocardial ischemia, severe stenosis, mechanical intestinal obstruction, urinary tract infection or urinary tract obstruction, pregnant women, bromine Allergies, etc.; 15. Suffering from a history of neuromuscular disease or arthritis; 16. Diaphragm dysfunction, pneumothorax, pleural effusion, mediastinal gas; 17. Alcoholism or drug abuse in the past; 18. Check the acid-base balance disorder before surgery; 19. Preoperative assessment of patients with difficult airways; 20. Fasting blood glucose >=11.1 mmol/L during screening period; 21. Non-Asian population; 22. He has participated in drug clinical trials as a subject in the past 3 months; 23. Planned to be discharged within 12 hours after surgery, intubation before operation, planned to be admitted to the intensive care unit before surgery, and surgery or anesthesia plan for 7 days per operation; 24. The investigator judged that the patient was not eligible for the other conditions of the clinical trial.

Design outcomes

Primary

MeasureTime frame
Incidence of residual neuromuscular block in each group;hypoxaemia;

Secondary

MeasureTime frame
Extubation time for each group;

Countries

China

Contacts

Public ContactXia Haifa

Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

haifaxia@163.com+86 15827639333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026