Residual Neuromuscular Block in the Post-Anesthetic Unit and Postoperative Complications

Postoperative Complications Clinical Trial

— Porcerito  

Official title:

Residual Neuromuscular Block in the Post-Anesthetic Unit and Postoperative Complications

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06386354
• Other study ID #: 2023-464-1
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Dr. Negrin University Hospital
• Contact: Ángel Becerra Bolaños, PhD
• Phone: +34928450370
• Email: angbecbol[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient.

Description:

The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient. In this prospective observational study, all patients who underwent general anesthesia with neuromuscular blockade were studied consecutively for one month to evaluate the presence of residual neuromuscular blockade and its potential consequences during hospital admission. .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient undergoing surgical intervention under general anesthesia that requires the use of neuromuscular block during the study time and that required hospital admission.

• Informed consent signature.

Exclusion Criteria:

• Neuromuscular disease

• Not having received neuromuscular block during the intervention

• Admission to the outpatient surgery unit

• Admission to the postoperative intensive care unit

• Patients who signed informed consent, but postoperative data could not be collected upon arrival at the PACU.

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Postoperative Complications
• Postoperative Neuromuscular Block

Intervention

Diagnostic Test:
• Train-of-four
Patients submitted to general anesthesia with neuromuscular block will be monitored at their arrival to the Post-Anesthesia Care Unit to assess the presence of residual neuromuscular block.

Locations

Country	Name	City	State
Spain	Ángel Becerra	Las Palmas De Gran Canaria	Las Palmas

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Negrin University Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual Neuromuscular Block	Train-Of-Four ratio at arrival to the Post-Anesthetic Care Unit	5 minutes postoperatively
Primary	Residual Neuromuscular Block	Train-Of-Four ratio 3 minutes after the arrival to the Post-Anesthetic Care Unit	8 minutes postoperatively
Secondary	Postoperative complications	Postoperative complications during hospital admission	30 days postoperatively