Interindividual Variability in Duration of Action of Rocuronium in Pediatric Patients (DurAct)

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

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.

Study Overview

• Status: Completed
• Conditions: Muscle Relaxation
• Intervention / Treatment: Other: measurement of the depth of neuromuscular blockade

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 107

Contacts and Locations

Study Locations

• Czechia
  • South Moravian region
    • Brno, South Moravian region, Czechia, 62500
      • Brno University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.; Other Names: neuromuscular blockade depth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
TOF 1 recovery	Comparison of duration of clinical action after single-dose rocuronium to TOF 1 relative to patient weight, gender, and height	Intraoperatively
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
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
Muscle relaxation reversal	Identification of a patient subgroup requiring antagonization after a surgical procedure	Intraoperatively
Postoperative complications	Monitoring of postoperative complications of general anesthesia	24 hours postoperatively
Impact of sevoflurane anesthesia on the pharmacodynamics of rocuronium	Influence of sevoflurane concentration on rocuronium pharmacodynamics	intraoperatively
Impact of body temperature on pharmacodynamics of rocuronium	Influence of temperature on rocuronium pharmacodynamics	intraoperatively

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Investigators: Study Chair: Petr Stourac, prof. MD., Ph.D., MBA, Department of paediatric anaesthesia and intensive care medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: rocuronium; duration; muscle relaxant
• Other Study ID Numbers: KDAR FN Brno DurAct

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No