Interindividual Variability in Duration of Action of Rocuronium in Pediatric Patients

Muscle Relaxation Clinical Trial

— DurAct  

Official title:

Interindividual Variability in Duration of Action of Rocuronium in Pediatric Patients: a Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05529420
• Other study ID #: KDAR FN Brno DurAct
• Status: Recruiting
• Start date: September 5, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2022
• Source: Brno University Hospital
• Contact: Katarina Szturzova, MD
• Phone: 532234695
• Email: Szturzova.Katarina[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Given the observational study design, we expect that no informed consent will be required. 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. Standard monitoring during general anesthesia will be carried out including measurement of the depth of neuromuscular blockade (Train of Four, TOF, Avance CS2 machine, relaxometry module, stimulating current of 50 mA) every minute and body temperature monitoring. Subsequently, these parameters including the age-related minimum alveolar concentration of sevoflurane will be documented in the Case Report Form (CRF).

Rocuronium will be administered at a dose according to the Summary of Product Characteristics (SPC) and local expertise. Patient demographic parameters, dose of rocuronium, time of its administration, and 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. In addition, reversal of neuromuscular blockade if applicable and the Aldrete score in the first and fifth minute after extubation will be recorded.

In patients monitored after an intervention in a recovery room, possible complications occurring within at least 30 minutes postoperatively will be documented (desaturation, the need for oxygen therapy, tachycardia >150 beats per minute, bradycardia <50 beats per minute, aspiration, sore throat, cough, hoarseness). All patients will be screened for aspiration pneumonia on chest X-ray within the first 24 hours after an intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Muscle Relaxation

Intervention

Other:
• measurement of the depth of neuromuscular blockade
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.

Locations

Country	Name	City	State
Czechia	Brno University Hospital	Brno	South Moravian Region

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	TOF 1 recovery	Comparison of duration of clinical action after single-dose rocuronium to TOF 1 relative to patient weight, gender, and height	Intraoperatively
Secondary	Muscle relaxation recovery time characteristics	Comparison of interval from single-dose rocuronium to TOF 2, 3, and 4 in different pediatric age groups and relative to patient weight, gender, and height	Intraoperatively
Secondary	Time to full muscle relaxation recovery	Comparison of interval from single-dose rocuronium to full recovery in different pediatric age groups and relative to patient weight, gender, and height	Intraoperatively
Secondary	Muscle relaxation reversal	Identification of a patient subgroup requiring antagonization after a surgical procedure	Intraoperatively
Secondary	Postoperative complications	Monitoring of postoperative complications of general anesthesia	24 hours postoperatively
Secondary	Impact of sevoflurane anesthesia on the pharmacodynamics of rocuronium	Influence of sevoflurane concentration on rocuronium pharmacodynamics	intraoperatively
Secondary	Impact of body temperature on pharmacodynamics of rocuronium	Influence of temperature on rocuronium pharmacodynamics	intraoperatively