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NCT Number: NCT07831434

Postoperative Residual Neuromuscular Block and Passive Smoke Exposure in Pediatric Dental Patients

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.

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Key information

Conditions

Postoperative Residual Curarization Delayed Emergence from Anesthesia Neuromuscular Block Prolonged Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University-Cerrahpasa, Institute of Cardiology

Istanbul, 34093, Turkey (Türkiye)

Location contact

Metin ilteray Kıkılı, MD

CONTACT

[email protected]

+905439782131

Metin ilteray Kıkılı, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Known neuromuscular disease
  • Known allergy or contraindication to rocuronium
  • Use of medications known to significantly affect neuromuscular transmission
  • Severe hepatic or renal dysfunction
  • Inability to obtain reliable postoperative TOF measurements

Treatment and study plan

Passive Smoke Exposure

Other

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

Primary outcomes

  1. Incidence of Postoperative Residual Neuromuscular Block

    Time frame: At admission to the post-anesthesia care unit (PACU), immediately after extubation

    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.

Secondary outcomes

  1. Association Between Passive Smoke Exposure and Postoperative Residual Neuromuscular Block, Measured as an Odds Ratio

    Time frame: At admission to the post-anesthesia care unit (PACU), immediately after extubation

    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.

  2. Association Between Postoperative TOF Ratio and Postoperative Respiratory Complications, Measured as an Odds Ratio

    Time frame: From admission to the post-anesthesia care unit (PACU) through PACU discharge

    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.

  3. Association Between Time Since the Last Rocuronium Dose and Postoperative Residual Neuromuscular Block, Measured as an Odds Ratio

    Time frame: At admission to the post-anesthesia care unit (PACU), immediately after extubation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Metin ilteray Kıkılı, MD

CONTACT

[email protected]

+905439782131

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Association Between Postoperative Residual Neuromuscular Block After Rocuronium Administration and Passive Smoke Exposure in Pediatric Patients Undergoing Dental Procedures

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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