An observational study in Postoperative Residual Curarization and Neuromuscular Block Prolonged, sponsored by Istanbul University - Cerrahpasa. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Istanbul University - Cerrahpasa · Observational
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.
This is a prospective, single-center observational cohort study involving children aged 2-12 years undergoing elective dental procedures under general anesthesia in whom rocuronium is administered for neuromuscular blockade. The study is designed to determine the incidence of postoperative residual neuromuscular block (PRNB) after clinical extubation and to investigate whether passive smoke exposure is associated with an increased risk of PRNB.
Anesthetic management will be performed according to the study protocol. Following clinical recovery and extubation, patients will be transferred to the post-anesthesia care unit (PACU), where quantitative neuromuscular function will be assessed using a TOF-Watch SX monitor. Ulnar nerve stimulation and the adductor pollicis response will be used for train-of-four (TOF) monitoring. PRNB will be defined as a TOF ratio \<0.9.
Passive smoke exposure will be assessed using information obtained from the parent or legal guardian, including the presence and number of smokers in the household, smoking by the primary caregiver, smoking inside the home, daily cigarette consumption, and the duration of the child's exposure. Participants will be classified according to the presence or absence of passive smoke exposure.
In addition to determining the incidence of PRNB, the study will evaluate the association between passive smoke exposure and PRNB, the relationship between TOF ratio and postoperative respiratory complications, and the effect of the interval between the last dose of rocuronium and TOF assessment on PRNB.
98 studies on the registry are indexed under Delayed Emergence from Anesthesia; 17 are open to participants now.
This study's planned enrollment of 55 is below the median of 100 across 39 observational studies indexed under Delayed Emergence from Anesthesia.
Browse Delayed Emergence from Anesthesia studies →Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children with passive smoke exposure as reported by the parent or legal guardian
Other: Passive Smoke Exposure
Children without passive smoke exposure as reported by the parent or legal guardian
Passive 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
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 extubation
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 extubation
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 discharge
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 extubation
Plan to share: No
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Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 21 observational studies under Delayed Emergence from Anesthesia, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 32. This study's planned 12 months is above that.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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