Postoperative Residual Neuromuscular Block and Passive Smoke Exposure in Pediatric Dental Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-12
SponsorIstanbul University - Cerrahpasa
About this trial
Postoperative residual neuromuscular block (PRNB) may persist despite apparent clinical recovery from neuromuscular blockade and may increase the risk of postoperative respiratory complications. Quantitative neuromuscular monitoring is therefore important for identifying incomplete neuromuscular recovery. This prospective, single-center observational cohort study aims to determine the incidence of PRNB in pediatric patients undergoing dental procedures under general anesthesia with rocuronium and to evaluate the association between passive smoke exposure and PRNB. Children aged 2-12 years will undergo quantitative neuromuscular assessment using the TOF-Watch SX after clinical extubation and admission to the post-anesthesia care unit (PACU). PRNB will be defined as a train-of-four (TOF) ratio \<0.9. The incidence of PRNB will be determined, and its association with passive smoke exposure and perioperative clinical variables will be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 2-12 years
Scheduled to undergo dental procedures under general anesthesia
Administration of rocuronium as part of routine anesthetic management
Written informed consent obtained from a parent or legal guardian
Disqualifiers
Known neuromuscular disease
Known allergy or contraindication to rocuronium
Use of medications known to significantly affect neuromuscular transmission
Severe hepatic or renal dysfunction
Trial population
The study population will consist of children aged 2-12 years undergoing dental procedures under general anesthesia with rocuronium administration. Participants will be categorized according to the presence or absence of passive smoke exposure as reported by a parent or legal guardian. Postoperative neuromuscular function will be assessed using quantitative train-of-four monitoring after extubation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Passive Smoke Exposure
Other interventionPassive smoke exposure is defined based on parental or legal guardian report of the child's exposure to tobacco smoke in the household or other environments. No intervention is administered as part of the study
Treatment groups
55 Participants
are divided into 2 treatment groupsGroup A: Passive Smoke Exposure1 intervention
Group B: No Passive Smoke Exposure0 interventions
Trial outcomes
Primary outcomes
1
Incidence of Postoperative Residual Neuromuscular Block
Percentage of participants with postoperative residual neuromuscular block (PRNB), defined as a normalized train-of-four (TOF) ratio \<0.90 measured at the adductor pollicis using TOF-Watch SX neuromuscular monitoring.
Time frame
At admission to the post-anesthesia care unit (PACU), immediately after extubationSecondary outcomes
1
Association Between Passive Smoke Exposure and Postoperative Residual Neuromuscular Block, Measured as an Odds Ratio
The association between passive smoke exposure and postoperative residual neuromuscular block (PRNB) will be assessed using an odds ratio (OR). PRNB is defined as a normalized TOF ratio \<0.90 measured at the adductor pollicis using TOF-Watch SX neuromuscular monitoring. Multivariable logistic regression will be used to estimate the adjusted odds ratio for PRNB associated with passive smoke exposure.
Time frame
At admission to the post-anesthesia care unit (PACU), immediately after extubation2
Association Between Postoperative TOF Ratio and Postoperative Respiratory Complications, Measured as an Odds Ratio
The association between postoperative TOF ratio and postoperative respiratory complications will be assessed. Postoperative respiratory complications will be defined as the occurrence of one or more of the following events during the PACU stay: oxygen saturation (SpO₂) \<90%, requirement for supplemental oxygen due to hypoxemia, upper airway obstruction requiring intervention, or requirement for assisted ventilation. TOF ratio will be measured at the adductor pollicis using TOF-Watch SX neuromuscular monitoring.
Time frame
From admission to the post-anesthesia care unit (PACU) through PACU discharge3
Association Between Time Since the Last Rocuronium Dose and Postoperative Residual Neuromuscular Block, Measured as an Odds Ratio
The association between the time interval from the last rocuronium administration to postoperative TOF measurement and PRNB will be assessed using an odds ratio (OR). The time interval will be recorded in minutes. PRNB is defined as a normalized TOF ratio \<0.90 measured at the adductor pollicis using TOF-Watch SX neuromuscular monitoring.
Time frame
At admission to the post-anesthesia care unit (PACU), immediately after extubationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: