Neuromuscular BlockadeSUGA-PEDNCT07902193
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
An observational study of Neuromuscular Blockade and Delayed Emergence From Anesthesia, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Neuromuscular Blockade, Delayed Emergence From Anesthesia, Emergence Agitation
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2026to 30 Nov 2029
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- Age 2 to 17 years
- American Society of Anesthesiologists (ASA) physical status I
- Elective adenoidectomy or adenotonsillectomy under general anesthesia maintained with sevoflurane
- Neuromuscular blockade with rocuronium 0.6 milligrams per kilogram (mg/kg)
- Sugammadex 4 mg/kg administered at least 60 minutes after rocuronium
- Planned extubation in the operating room
- Written informed consent from a parent or legal guardian
Who cannot join
- ASA physical status II or higher
- Neuromuscular disease (e.g., myasthenia gravis, muscular dystrophy)
- History of hepatic or renal dysfunction
- Regular use of drugs affecting neuromuscular transmission (e.g., steroids, aminoglycosides, magnesium)
- History of prematurity (less than 37 weeks of gestation)
- Morbid obesity (body mass index [BMI] above the 95th percentile for age and sex)
Show all 11Show fewer
- Serious cardiac, pulmonary or neurological disease
- Known allergy or hypersensitivity, particularly to sugammadex or rocuronium
- End-tidal sevoflurane minimum alveolar concentration (MAC) at the time of sugammadex administration outside the defined cohort ranges
- Unplanned intraoperative events (e.g., major bleeding, prolonged surgery, need for additional drugs)
- Refusal of consent by a parent or legal guardian
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Buğra G Akman contact
Turkey (Türkiye)1 site
Tekirdağ Namık Kemal University Hospital, Department of Anesthesiology and Reanimation
Tekirdağ
Ahmet Gültekin, ahmetgultekin82@yahoo.com
About this study
Official title: Effect of Sugammadex Administration Under Deep Versus Light Sevoflurane Anesthesia on Recovery Characteristics and Complications in Children Undergoing Adenoidectomy or Adenotonsillectomy: A Prospective Observational Cohort Study
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.
Read the detailed description
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:
- Deep cohort: 1.0 to 1.1 MAC
- Light cohort: 0.3 to 0.4 MAC
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.
- Keywords
- sugammadex, sevoflurane, adenotonsillectomy, extubation time, Richmond Agitation-Sedation Scale, neuromuscular blockade reversal, pediatric anesthesia
- Medical subject headings
- Delayed Emergence from Anesthesia, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Deep reversal | 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. | |
| Light reversal | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From sugammadex administration to tracheal extubation, assessed up to 60 minutes
Secondary outcomes (10)
Time from end of surgery to extubation
Time from the end of surgery to tracheal extubation, in seconds.
Measured: 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.
Measured: 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.
Measured: 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)..
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From sugammadex administration to 10 minutes after arrival in the post-anesthesia care unit (PACU)
Incidence of laryngospasm
Number of participants with laryngospasm.
Measured: 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.
Measured: 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.
Measured: From sugammadex administration to 10 minutes after arrival in the post-anesthesia care unit (PACU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Gültekin, Namik Kemal University
- Investigators
- Ahmet Gültekin, MD, Principal investigator, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902193
- Sponsor's protocol ID
- NamikKU-AGultekin-3
- Acronym
- SUGA-PED
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality under national data protection law (KVKK).
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sugammadex Administration Under Deep Versus Light Sevoflurane Anesthesia on Recovery Characteristics and Complications in Children Undergoing Adenoidectomy or Adenotonsillectomy: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07902193
- Acronym / sponsor ID
- SUGA-PED / NamikKU-AGultekin-3
- Keywords
- sugammadex, sevoflurane, adenotonsillectomy, extubation time, Richmond Agitation-Sedation Scale, neuromuscular blockade reversal, pediatric anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 28 Oct 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.
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.
Detailed description
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:
- Deep cohort: 1.0 to 1.1 MAC
- Light cohort: 0.3 to 0.4 MAC
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep reversal | – | –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. |
| Light reversal | – | –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. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (7 listed)
- Age 2 to 17 years
- American Society of Anesthesiologists (ASA) physical status I
- Elective adenoidectomy or adenotonsillectomy under general anesthesia maintained with sevoflurane
- Neuromuscular blockade with rocuronium 0.6 milligrams per kilogram (mg/kg)
- Sugammadex 4 mg/kg administered at least 60 minutes after rocuronium
Key exclusion criteria (11 listed)
- ASA physical status II or higher
- Neuromuscular disease (e.g., myasthenia gravis, muscular dystrophy)
- History of hepatic or renal dysfunction
- Regular use of drugs affecting neuromuscular transmission (e.g., steroids, aminoglycosides, magnesium)
- History of prematurity (less than 37 weeks of gestation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to extubation
Time frame: From sugammadex administration to tracheal extubation, assessed up to 60 minutes
Time from sugammadex administration to tracheal extubation, in minutes and seconds. Time from end of surgery to extubation will also be recorded.
10 secondary outcomes
Time from end of surgery to extubation
Time frame: From the end of surgery to tracheal extubation, assessed up to 60 minutes
Emergence agitation
Time frame: On arrival in the post-anesthesia care unit (PACU) and at 5 and 10 minutes after arrival
Heart rate
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
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)
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
Time frame: From tracheal extubation to 10 minutes after arrival in the post-anesthesia care unit (PACU)
Incidence of bradycardia
Time frame: From sugammadex administration to 10 minutes after arrival in the post-anesthesia care unit (PACU)
Incidence of laryngospasm
Time frame: From sugammadex administration to 10 minutes after arrival in the post-anesthesia care unit (PACU)
Incidence of anaphylaxis
Time frame: From sugammadex administration to 10 minutes after arrival in the post-anesthesia care unit (PACU)
Incidence of skin rash
Time frame: From sugammadex administration to 10 minutes after arrival in the post-anesthesia care unit (PACU)
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 28 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality under national data protection law (KVKK).
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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.
Buğra G Akman contact
Ahmet Gültekin, MD principal investigator
Namik Kemal University
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 Neuromuscular Blockade and Delayed Emergence From Anesthesia, run by Namik Kemal University 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 7 inclusion and 11 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 28 Oct 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 Ahmet Gültekin, MD (+905062732482, ahmetgultekin82@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to extubation (time frame: From sugammadex administration to tracheal extubation, assessed up to 60 minutes). 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 28 Oct 2026.