An observational study in Neuromuscular Blockade, Delayed Emergence From Anesthesia and Emergence Agitation, sponsored by Namik Kemal University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Namik Kemal University · Observational
Sugammadex is routinely used to reverse rocuronium-induced neuromuscular blockade in children. In clinical practice, it is given either while the child is still deeply anesthetized or after the anesthetic has lightened. Whether this timing affects the recovery profile is unknown.
This prospective observational study will compare time to extubation, emergence agitation and perioperative complications in children aged 2 to 17 years who receive sugammadex under deep (1.0 to 1.1 minimum alveolar concentration [MAC]) versus light (0.3 to 0.4 MAC) sevoflurane anesthesia, according to the routine practice of the attending anesthesiologist. The investigators will not influence any clinical decision.
All anesthetic management, including drug choice, dosing and the timing of sugammadex administration, will be determined solely by the attending anesthesiologist according to routine clinical practice. The investigators will only record data.
Eligible children are American Society of Anesthesiologists (ASA) physical status I patients aged 2 to 17 years undergoing elective adenoidectomy or adenotonsillectomy under sevoflurane anesthesia. They must have received rocuronium 0.6 milligrams per kilogram (mg/kg), and sugammadex 4 mg/kg must have been administered at least 60 minutes after rocuronium. Patients will be assigned to cohorts according to the age-adjusted end-tidal sevoflurane minimum alveolar concentration (MAC) recorded at the moment of sugammadex administration:
Heart rate and peripheral oxygen saturation (SpO2) will be recorded before the start of emergence, every minute for the first 10 minutes and at 15 minutes after the start of emergence, and at 1, 5 and 10 minutes after arrival in the post-anesthesia care unit (PACU). Blood pressure will be recorded before the start of emergence, every 5 minutes up to 15 minutes, and at 1, 5 and 10 minutes after arrival in the PACU. Time to extubation will be recorded in seconds. Emergence agitation will be assessed with the Richmond Agitation-Sedation Scale (RASS) on arrival in the PACU and at 5 and 10 minutes after arrival. Postoperative nausea and vomiting, skin rash, anaphylaxis, bradycardia and laryngospasm will be recorded.
Differences between cohorts will be adjusted using multivariable regression analysis. Reporting will follow the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.
98 studies on the registry are indexed under Delayed Emergence from Anesthesia; 17 are open to participants now.
This study's planned enrollment of 140 is above the median of 100 across 39 observational studies indexed under Delayed Emergence from Anesthesia.
Browse Delayed Emergence from Anesthesia studies →Namik Kemal University is the lead sponsor of 61 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children aged 2 to 17 years with American Society of Anesthesiologists (ASA) physical status I undergoing elective adenoidectomy or adenotonsillectomy under general anesthesia maintained with sevoflurane at Tekirdag Namik Kemal University Hospital, Department of Anesthesiology and Reanimation. Consecutive eligible patients will be enrolled after written informed consent is obtained from a parent or legal guardian.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children who receive sugammadex 4 mg/kg while end-tidal sevoflurane is 1.0-1.1 MAC, as decided by the attending anesthesiologist in routine practice. Intervention: Drug: Sugammadex. Administered as part of routine care; not assigned by the investigators.
Children who receive sugammadex 4 mg/kg after end-tidal sevoflurane has decreased to 0.3-0.4 MAC, as decided by the attending anesthesiologist in routine practice. Intervention: Drug: Sugammadex. Administered as part of routine care; not assigned by the investigators.
Time to extubation
Time from sugammadex administration to tracheal extubation, in minutes and seconds. Time from end of surgery to extubation will also be recorded.
Time frame: From sugammadex administration to tracheal extubation, assessed up to 60 minutes
Time from end of surgery to extubation
Time from the end of surgery to tracheal extubation, in seconds.
Time frame: From the end of surgery to tracheal extubation, assessed up to 60 minutes
Emergence agitation
Agitation will be assessed with the Richmond Agitation-Sedation Scale (RASS), which ranges from -5 (unarousable) to +4 (combative), with 0 indicating alert and calm; higher scores indicate greater agitation. RASS scores and the incidence of agitation, defined as a RASS score of +1 or higher, will be reported.
Time frame: On arrival in the post-anesthesia care unit (PACU) and at 5 and 10 minutes after arrival
Heart rate
Heart rate in beats per minute.
Time frame: Before the start of emergence; every minute for the first 10 minutes and at 15 minutes after the start of emergence; and at 1, 5 and 10 minutes after arrival in the post-anesthesia care unit (PACU)
Blood pressure
Systolic, diastolic and mean arterial blood pressure in millimeters of mercury (mmHg)..
Time frame: Before the start of emergence; every 5 minutes up to 15 minutes after the start of emergence; and at 1, 5 and 10 minutes after arrival in the post-anesthesia care unit (PACU)
Peripheral oxygen saturation (SpO2)
Peripheral oxygen saturation measured by pulse oximetry, in percent.
Time frame: Before the start of emergence; every minute for the first 10 minutes and at 15 minutes after the start of emergence; and at 1, 5 and 10 minutes after arrival in the post-anesthesia care unit (PACU)
Incidence of postoperative nausea and vomiting
Number of participants with postoperative nausea and/or vomiting.
Time frame: From tracheal extubation to 10 minutes after arrival in the post-anesthesia care unit (PACU)
Incidence of bradycardia
Number of participants with bradycardia, defined as a heart rate below the age-specific lower limit or a decrease of more than 20% from baseline.
Time frame: From sugammadex administration to 10 minutes after arrival in the post-anesthesia care unit (PACU)
Incidence of laryngospasm
Number of participants with laryngospasm.
Time frame: From sugammadex administration to 10 minutes after arrival in the post-anesthesia care unit (PACU)
Incidence of anaphylaxis
Diagnosed according to the NIAID/FAAN clinical criteria and graded by Ring-Messmer.
Time frame: From sugammadex administration to 10 minutes after arrival in the post-anesthesia care unit (PACU)
Incidence of skin rash
Number of participants with skin rash.
Time frame: From sugammadex administration to 10 minutes after arrival in the post-anesthesia care unit (PACU)
Plan to share: No — Individual participant data will not be shared due to patient confidentiality under national data protection law (KVKK).
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Delayed Emergence from Anesthesia →
Namik Kemal University