Interindividual Variability in Duration of Action of Rocuronium in Pediatric Patients

NCT05529420 | Completed

• 1 other identifier: KDAR FN Brno DurAct
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

Muscle relaxants represent an important part of general anesthesia in adult and pediatric patients. Their role is to facilitate intubation and enable some surgical interventions. At our workplace, monitoring of the depth of neuromuscular blockade is a standard procedure in accordance with the 2017 recommendation of ČSARIM entitled "Principles of Patient Safety in Anesthesiology" \[1,2\]. At present, we mainly use rocuronium. One of the advantages of this non-depolarizing steroidal muscle relaxant with a rapid onset and intermediate duration of action is the existence of the specific antagonist sugammadex.

Conditions

Muscle Relaxation

Keywords

duration; muscle relaxant; rocuronium

Outcome Measures

Primary Outcomes (1)

• Age-based TOF 1 recovery

  Comparison of duration of clinical action after single-dose rocuronium to TOF 1 in different pediatric age groups

  intraoperatively

Secondary Outcomes (7)

• TOF 1 recovery

  Intraoperatively

• Muscle relaxation recovery time characteristics

  Intraoperatively

• Time to full muscle relaxation recovery

  Intraoperatively

• Muscle relaxation reversal

  Intraoperatively

• Postoperative complications

  24 hours postoperatively

Study Arms (1)

Pediatric patients rocuronium

In pediatric patients undergoing a planned general anesthesia with non-depolarizing muscle relaxants, induction of anesthesia will involve either standard intravenous (an opioid, anesthetic, muscle relaxant) or inhalational agents according to the preference of the anesthesiologist.

Other: measurement of the depth of neuromuscular blockade

Interventions

measurement of the depth of neuromuscular blockade OTHER

time of TOF 1 measurement (= clinical effect, stimulation of the ulnar nerve - adductor pollicis muscle tension) will be documented in the CRF and if there is no need to add further doses of the muscle relaxant, TOF 2, TOF 3, TOF 4, and TOF-R ≥ 0,9 (= time to full recovery from the effect of the non-depolarizing muscle relaxant) will also be registered.

Also known as: neuromuscular blockade depth

Pediatric patients rocuronium

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients aged 0 to 18 years admitted for a planned intervention in general anesthesia with orotracheal or nasotracheal intubation and use of the muscle relaxant rocuronium

You may qualify if:

• Pediatric patients aged 0 to 18 years admitted for a planned intervention in general anesthesia with orotracheal or nasotracheal intubation and use of the muscle relaxant rocuronium
• ASA score 1 or 2

You may not qualify if:

• Patients requiring more types of muscle relaxants during general anesthesia induction
• Patients requiring a rapid sequence induction to general anesthesia
• Neuromuscular disease
• Concomitant medication interfering with the metabolism of muscle relaxants (anticonvulsants, aminoglycosides, polypeptide antibiotics)
• Comorbidities - renal or hepatic disorders
• ASA ≥ 3

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

Brno University Hospital

Brno, South Moravian, 62500, Czechia

Location

MeSH Terms

Conditions

Muscle Hypotonia

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Petr Stourac, prof. MD., Ph.D., MBA

  Department of paediatric anaesthesia and intensive care medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: September 5, 2022
• Primary Completion: August 31, 2023
• Study Completion: September 1, 2023
• Last Updated: November 21, 2024

Record last verified: 2022-09

Locations

CZ (1)