Neuromuscular Block, ResidualNCT07175623
Methylprednisolone vs Dexamethasone Interaction With Sugammadex in Pediatric Patients
A study testing Methyl Prednisolone (MP), Dexamethasone (0.2 mg/kg) and Saline (0.9% NaCl) in people with Neuromuscular Block, Residual and Pain Management, run by Konya City Hospital at 2 sites in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to compare the interaction of methylprednisolone and dexamethasone with sugammadex in pediatric patients undergoing adenoidectomy and/or tonsillectomy. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Neuromuscular Block, Residual, Pain Management, Postoperative Nausea
- What is being tested?
- Methyl Prednisolone (MP), Dexamethasone (0.2 mg/kg) and Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 16 Sep 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-12 years
- American Society of Anesthesiologists (ASA) physical status I-II
Who cannot join
- ASA physical status ≥ III
- Emergency surgery
- Known allergy or contraindication to neuromuscular blocking agents, sugammadex, or corticosteroids
- Chronic or recent systemic corticosteroid use (within the last 3 months)
- Neuromuscular disorders (e.g., muscular dystrophy, myasthenia gravis)
- Severe hepatic or renal dysfunction
Show all 10Show fewer
- Significant respiratory or cardiac disease
- Anticipated difficult airway or history of difficult intubation
- Developmental delay or craniofacial anomalies affecting airway management
- Refusal of consent
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bezmialem Vakıf Univerisity Dragos Hospital
Istanbul
Konya City Hospital
Konya, Karatay, 42050
About this study
Official title: Comparison of the Effects of the Interaction of Methylprednisolone and Dexamethasone With Sugammadex on Rocuronium Reversal Time, Postoperative Pain, and Nausea in Pediatric Patients: A Randomized Controlled Trial
This randomized controlled trial aims to compare the interaction of methylprednisolone and dexamethasone with sugammadex in pediatric patients undergoing adenoidectomy and/or tonsillectomy. The primary objective is to evaluate the effect of these corticosteroids on the reversal time of rocuronium-induced neuromuscular block by sugammadex. Secondary outcomes include postoperative pain, nausea and vomiting, extubation time, and adverse events. Eligible participants are children aged 5 to 12 years, ASA I-II, scheduled for elective surgery under general anesthesia. The study is designed as a triple-blind, parallel-group trial with three arms: methylprednisolone, dexamethasone, and placebo.
Read the detailed description
Neuromuscular blocking agents (NMBAs) are widely used in pediatric anesthesia to facilitate tracheal intubation and optimize surgical conditions. However, residual neuromuscular block may increase the risk of postoperative respiratory complications, especially in children who have shorter safe apnea times due to their unique anatomical and physiological characteristics. Sugammadex, a modified γ-cyclodextrin, is a selective reversal agent for aminosteroid NMBAs such as rocuronium. Its mechanism of encapsulating steroidal neuromuscular blocking molecules raises concerns about potential interactions with other steroidal drugs, including perioperatively used corticosteroids.
Corticosteroids are commonly administered in the perioperative period for their antiemetic, analgesic, and anti-inflammatory effects. Dexamethasone is widely accepted for postoperative nausea and vomiting prophylaxis, while methylprednisolone is preferred for its rapid anti-inflammatory effect. Previous studies have suggested that the structural similarity of corticosteroids to rocuronium may interfere with sugammadex binding, but the available evidence is conflicting, and data on methylprednisolone remain limited. In a prior study, methylprednisolone was shown to prolong sugammadex reversal time slightly, but no direct comparison with another corticosteroid was performed.
This randomized controlled trial is designed to compare the effects of methylprednisolone and dexamethasone on sugammadex reversal time in pediatric patients undergoing adenoidectomy and/or tonsillectomy. The study will assess whether methylprednisolone has a stronger interaction with sugammadex compared with dexamethasone, leading to prolonged recovery from rocuronium block. Secondary outcomes will include postoperative pain, nausea and vomiting, extubation time, and adverse events. The results may provide clinically relevant evidence regarding the choice of corticosteroid in pediatric anesthesia when sugammadex is used for neuromuscular block reversal.
- Being tested
- Methyl Prednisolone (MP), Dexamethasone (0.2 mg/kg), Saline (0.9% NaCl)
- Keywords
- Sugammadex, Methylprednisolone, Dexamethasone, Postoperative pain, Postoperative nausea, Pediatric Anesthesia
- Medical subject headings
- Delayed Emergence from Anesthesia, Agnosia, Postoperative Nausea and Vomiting, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyl Prednisolone (MP)Drug
Dose: 1 mg/kg IV
Timing: at the induction of anesthesia
Dexamethasone (0.2 mg/kg)Drug
Dose: 0.2 mg/kg IV (glucocorticoid equivalent to 1 mg/kg methylprednisolone)
Timing: at the induction of anesthesia
Saline (0.9% NaCl)Drug
Dose: 5 ml IV
Timing: at the induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Experimental | Patients will receive intravenous methylprednisolone 1 mg/kg at the induction of anesthesia. Receives: Drug: Methyl Prednisolone (MP) |
| Dexamethasone | Experimental | Patients will receive intravenous dexamethasone 0.2 mg/kg at the induction of anesthesia Receives: Drug: Dexamethasone (0.2 mg/kg) |
| Control | Placebo comparator | Patients will receive 5 ml of intravenous normal saline at the induction of anesthesia Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery of neuromuscular function (normalised train-of-four ratio ≥ 0.9) after sugammadex injection
Time from intravenous sugammadex administration to restoration of normalised train-of-four ratio ≥ 0.9, measured by quantitative acceleromyography at the adductor pollicis muscle under standardized monitoring conditions.
Measured: From intravenous administration of sugammadex until achievement of normalized TOF ratio ≥ 0.9 (in seconds).
Secondary outcomes (3)
Extubation time
Time from intravenous sugammadex administration to removal of the endotracheal tube, recorded by anesthesia staff.
Measured: From intravenous administration of sugammadex until tracheal extubation (in minutes).
Postoperative pain score
Faces Pain Scale-Revised (0-10) assessed at predefined time points; higher scores indicate more pain.
Measured: At 2 hours after surgery.
Postoperative Nausea Severity
Baxter Retching Faces (0-10) pictorial scale; higher scores indicate more severe nausea/retching.
Measured: At 2 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start16 Sep 2025
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular Block, ResidualStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MUSTAFA BÜYÜKCAVLAK, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175623
- Sponsor's protocol ID
- 12-5/2025
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gulec E, Biricik E, Turktan M, Hatipoglu Z, Unlugenc H. The Effect of Intravenous Dexamethasone on Sugammadex Reversal Time in Children Undergoing Adenotonsillectomy. Anesth Analg. 2016 Apr;122(4):1147-52. doi: 10.1213/ANE.0000000000001142.
PubMed 26771267Buonanno P, Laiola A, Palumbo C, Spinelli G, Servillo G, Di Minno RM, Cafiero T, Di Iorio C. Dexamethasone Does Not Inhibit Sugammadex Reversal After Rocuronium-Induced Neuromuscular Block. Anesth Analg. 2016 Jun;122(6):1826-30. doi: 10.1213/ANE.0000000000001294.
PubMed 27028777Murphy GS, Sherwani SS, Szokol JW, Avram MJ, Greenberg SB, Patel KM, Wade LD, Vaughn J, Gray J. Small-dose dexamethasone improves quality of recovery scores after elective cardiac surgery: a randomized, double-blind, placebo-controlled study. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):950-60. doi: 10.1053/j.jvca.2011.03.002. Epub 2011 May 11.
PubMed 21565530. Gold SJA, Harper NJN. The place of sugammadex in anaesthesia practice. Trends Anaesth Crit Care 2012; 2: 4-9.
Graham LA, Illarmo S, Wren SM, Mudumbai SC, Odden MC. Optimal multimodal analgesia combinations to reduce pain and opioid use following non-cardiac surgery: an instrumental variable analysis. Reg Anesth Pain Med. 2025 Jul 17:rapm-2025-106720. doi: 10.1136/rapm-2025-106720. Online ahead of print.
PubMed 40659442Aouad MT, Nasr VG, Yazbeck-Karam VG, Bitar MA, Bou Khalil M, Beyrouthy O, Harfouche D, Terrin N, Siddik-Sayyid S. A comparison between dexamethasone and methylprednisolone for vomiting prophylaxis after tonsillectomy in inpatient children: a randomized trial. Anesth Analg. 2012 Oct;115(4):913-20. doi: 10.1213/ANE.0b013e3182652a6a. Epub 2012 Jul 13.
PubMed 22798534Buyukcavlak M, Tire Y, Sari M, Ciftci C. Comparison of Methylprednisolone and Dexamethasone in Their Interaction With Sugammadex in Pediatric Patients: A Randomized Controlled Trial. Paediatr Anaesth. 2026 Oct 3. doi: 10.1002/pan.70322. Online ahead of print.
PubMed 42828493
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of the Interaction of Methylprednisolone and Dexamethasone With Sugammadex on Rocuronium Reversal Time, Postoperative Pain, and Nausea in Pediatric Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07175623
- Acronym / sponsor ID
- 12-5/2025
- Keywords
- Sugammadex, Methylprednisolone, Dexamethasone, Postoperative pain, Postoperative nausea, Pediatric Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 16 Sep 2025 (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.
This randomized controlled trial aims to compare the interaction of methylprednisolone and dexamethasone with sugammadex in pediatric patients undergoing adenoidectomy and/or tonsillectomy. The primary objective is to evaluate the effect of these corticosteroids on the reversal time of rocuronium-induced neuromuscular block by sugammadex. Secondary outcomes include postoperative pain, nausea and vomiting, extubation time, and adverse events. Eligible participants are children aged 5 to 12 years, ASA I-II, scheduled for elective surgery under general anesthesia. The study is designed as a triple-blind, parallel-group trial with three arms: methylprednisolone, dexamethasone, and placebo.
Detailed description
Neuromuscular blocking agents (NMBAs) are widely used in pediatric anesthesia to facilitate tracheal intubation and optimize surgical conditions. However, residual neuromuscular block may increase the risk of postoperative respiratory complications, especially in children who have shorter safe apnea times due to their unique anatomical and physiological characteristics. Sugammadex, a modified γ-cyclodextrin, is a selective reversal agent for aminosteroid NMBAs such as rocuronium. Its mechanism of encapsulating steroidal neuromuscular blocking molecules raises concerns about potential interactions with other steroidal drugs, including perioperatively used corticosteroids.
Corticosteroids are commonly administered in the perioperative period for their antiemetic, analgesic, and anti-inflammatory effects. Dexamethasone is widely accepted for postoperative nausea and vomiting prophylaxis, while methylprednisolone is preferred for its rapid anti-inflammatory effect. Previous studies have suggested that the structural similarity of corticosteroids to rocuronium may interfere with sugammadex binding, but the available evidence is conflicting, and data on methylprednisolone remain limited. In a prior study, methylprednisolone was shown to prolong sugammadex reversal time slightly, but no direct comparison with another corticosteroid was performed.
This randomized controlled trial is designed to compare the effects of methylprednisolone and dexamethasone on sugammadex reversal time in pediatric patients undergoing adenoidectomy and/or tonsillectomy. The study will assess whether methylprednisolone has a stronger interaction with sugammadex compared with dexamethasone, leading to prolonged recovery from rocuronium block. Secondary outcomes will include postoperative pain, nausea and vomiting, extubation time, and adverse events. The results may provide clinically relevant evidence regarding the choice of corticosteroid in pediatric anesthesia when sugammadex is used for neuromuscular block reversal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Experimental | Drug: Methyl Prednisolone (MP)Patients will receive intravenous methylprednisolone 1 mg/kg at the induction of anesthesia. |
| Dexamethasone | Experimental | Drug: Dexamethasone (0.2 mg/kg)Patients will receive intravenous dexamethasone 0.2 mg/kg at the induction of anesthesia |
| Control | Placebo comparator | Drug: Saline (0.9% NaCl)Patients will receive 5 ml of intravenous normal saline at the induction of anesthesia |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 5-12 years
- American Society of Anesthesiologists (ASA) physical status I-II
Key exclusion criteria (10 listed)
- ASA physical status ≥ III
- Emergency surgery
- Known allergy or contraindication to neuromuscular blocking agents, sugammadex, or corticosteroids
- Chronic or recent systemic corticosteroid use (within the last 3 months)
- Neuromuscular disorders (e.g., muscular dystrophy, myasthenia gravis)
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 |
|---|---|---|
| Methyl Prednisolone (MP)Dose: 1 mg/kg IV Timing: at the induction of anesthesia | Drug | Methylprednisolone |
| Dexamethasone (0.2 mg/kg)Dose: 0.2 mg/kg IV (glucocorticoid equivalent to 1 mg/kg methylprednisolone) Timing: at the induction of anesthesia | Drug | Dexamethasone |
| Saline (0.9% NaCl)Dose: 5 ml IV Timing: at the induction of anesthesia | Drug | Control |
Primary outcome
Time to recovery of neuromuscular function (normalised train-of-four ratio ≥ 0.9) after sugammadex injection
Time frame: From intravenous administration of sugammadex until achievement of normalized TOF ratio ≥ 0.9 (in seconds).
Time from intravenous sugammadex administration to restoration of normalised train-of-four ratio ≥ 0.9, measured by quantitative acceleromyography at the adductor pollicis muscle under standardized monitoring conditions.
3 secondary outcomes
Extubation time
Time frame: From intravenous administration of sugammadex until tracheal extubation (in minutes).
Postoperative pain score
Time frame: At 2 hours after surgery.
Postoperative Nausea Severity
Time frame: At 2 hours after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Background: PubMed 26771267Gulec E, Biricik E, Turktan M, Hatipoglu Z, Unlugenc H. The Effect of Intravenous Dexamethasone on Sugammadex Reversal Time in Children Undergoing Adenotonsillectomy. Anesth Analg. 2016 Apr;122(4):1147-52. doi: 10.1213/ANE.0000000000001142.
- Background: PubMed 27028777Buonanno P, Laiola A, Palumbo C, Spinelli G, Servillo G, Di Minno RM, Cafiero T, Di Iorio C. Dexamethasone Does Not Inhibit Sugammadex Reversal After Rocuronium-Induced Neuromuscular Block. Anesth Analg. 2016 Jun;122(6):1826-30. doi: 10.1213/ANE.0000000000001294.
- Background: PubMed 21565530Murphy GS, Sherwani SS, Szokol JW, Avram MJ, Greenberg SB, Patel KM, Wade LD, Vaughn J, Gray J. Small-dose dexamethasone improves quality of recovery scores after elective cardiac surgery: a randomized, double-blind, placebo-controlled study. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):950-60. doi: 10.1053/j.jvca.2011.03.002. Epub 2011 May 11.
- Background. Gold SJA, Harper NJN. The place of sugammadex in anaesthesia practice. Trends Anaesth Crit Care 2012; 2: 4-9.
- Background: PubMed 40659442Graham LA, Illarmo S, Wren SM, Mudumbai SC, Odden MC. Optimal multimodal analgesia combinations to reduce pain and opioid use following non-cardiac surgery: an instrumental variable analysis. Reg Anesth Pain Med. 2025 Jul 17:rapm-2025-106720. doi: 10.1136/rapm-2025-106720. Online ahead of print.
- Background: PubMed 22798534Aouad MT, Nasr VG, Yazbeck-Karam VG, Bitar MA, Bou Khalil M, Beyrouthy O, Harfouche D, Terrin N, Siddik-Sayyid S. A comparison between dexamethasone and methylprednisolone for vomiting prophylaxis after tonsillectomy in inpatient children: a randomized trial. Anesth Analg. 2012 Oct;115(4):913-20. doi: 10.1213/ANE.0b013e3182652a6a. Epub 2012 Jul 13.
- Derived from this study: PubMed 42828493Buyukcavlak M, Tire Y, Sari M, Ciftci C. Comparison of Methylprednisolone and Dexamethasone in Their Interaction With Sugammadex in Pediatric Patients: A Randomized Controlled Trial. Paediatr Anaesth. 2026 Oct 3. doi: 10.1002/pan.70322. Online ahead of print.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methyl Prednisolone (MP), Dexamethasone (0.2 mg/kg) and Saline (0.9% NaCl) in people with Neuromuscular Block, Residual and Pain Management, run by Konya City Hospital at 2 sites 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recovery of neuromuscular function (normalised train-of-four ratio ≥ 0.9) after sugammadex injection (time frame: From intravenous administration of sugammadex until achievement of normalized TOF ratio ≥ 0.9 (in seconds).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07175623, which also lists 7 linked publications.
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 29 Dec 2025.