Postoperative Residual CurarizationNCT07831434
Postoperative Residual Neuromuscular Block and Passive Smoke Exposure in Pediatric Dental Patients
An observational study of Postoperative Residual Curarization and Neuromuscular Block Prolonged, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Postoperative Residual Curarization, Neuromuscular Block Prolonged
- What is being tested?
- Passive Smoke Exposure
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Institute of Cardiology
Istanbul, Istanbul, 34093
Metin ilteray Kıkılı, MD, +905439782131, metin.kikili@iuc.edu.tr
drkikili@gmail.com
About this study
Official title: Association Between Postoperative Residual Neuromuscular Block After Rocuronium Administration and Passive Smoke Exposure in Pediatric Patients Undergoing Dental Procedures
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.
Read the detailed description
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.
- Being tested
- Passive Smoke Exposure
- Keywords
- Postoperative Residual Neuromuscular Block, Passive Smoke Exposure, Train-of-Four Monitoring, Rocuronium, Pediatric Anesthesia, Neuromuscular Monitoring
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Smoke ExposureOther
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
| Study group | Role | What they receive |
|---|---|---|
| Passive Smoke Exposure | Children with passive smoke exposure as reported by the parent or legal guardian Receives: Other: Passive Smoke Exposure | |
| No Passive Smoke Exposure | Children without passive smoke exposure as reported by the parent or legal guardian |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At admission to the post-anesthesia care unit (PACU), immediately after extubation
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At admission to the post-anesthesia care unit (PACU), immediately after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Residual CurarizationStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Metin İlteray Kıkılı, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831434
- Sponsor's protocol ID
- dM1I4S90
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Postoperative Residual Neuromuscular Block After Rocuronium Administration and Passive Smoke Exposure in Pediatric Patients Undergoing Dental Procedures
- ClinicalTrials.gov ID
- NCT07831434
- Acronym / sponsor ID
- dM1I4S90
- Keywords
- Postoperative Residual Neuromuscular Block, Passive Smoke Exposure, Train-of-Four Monitoring, Rocuronium, Pediatric Anesthesia, Neuromuscular Monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive Smoke Exposure | – | Other: Passive Smoke ExposureChildren with passive smoke exposure as reported by the parent or legal guardian |
| No Passive Smoke Exposure | – | –Children without passive smoke exposure as reported by the parent or legal guardian |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive Smoke ExposurePassive 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 | Other | Passive Smoke Exposure |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Residual Curarization and Neuromuscular Block Prolonged, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Metin ilteray Kıkılı, MD (+905439782131, metin.kikili@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Residual Neuromuscular Block (time frame: At admission to the post-anesthesia care unit (PACU), immediately after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.