Neuromuscular Block, ResidualNCT07187037
Methylprednisolone vs Dexamethasone: Effects on Sugammadex Reversal, Pain, and Nausea in Adults
A study testing Methylprednisolone (MP) and Dexamethasone in people with Neuromuscular Block, Residual and Pain, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to compare the effects of intravenous methylprednisolone and dexamethasone on the reversal time of rocuronium by sugammadex in adult patients undergoing elective septoplasty or rhinoplasty. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Block, Residual, Pain, Postoperative Nausea
- What is being tested?
- Methylprednisolone (MP) and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 30 Apr 2026
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients aged 18-65 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective septoplasty or rhinoplasty under general anesthesia
- Written informed consent obtained
Who cannot join
- ASA physical status ≥ III
- Emergency surgery
- Known allergy or contraindication to rocuronium, sugammadex, or corticosteroids
- Chronic or recent (within 3 months) systemic corticosteroid therapy
- Concomitant use of drugs that may interact with sugammadex (e.g., toremifene, flucloxacillin, fusidic acid)
- Neuromuscular disorders (e.g., myasthenia gravis, muscular dystrophy)
Show all 10Show fewer
- Significant hepatic, renal, respiratory, or cardiac dysfunction
- Anticipated difficult airway or history of difficult intubation
- Nasopharyngeal or oropharyngeal anomalies interfering with airway management
- Developmental or cognitive impairment interfering with informed consent or cooperation
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
Konya City Hospital
Karatay, Konya, 42050
MUSTAFA BÜYÜKCAVLAK, MD, 05064733392, mustafabcavlak@gmail.com
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 Adult Patients
This randomized controlled trial aims to compare the effects of intravenous methylprednisolone and dexamethasone on the reversal time of rocuronium by sugammadex in adult patients undergoing elective septoplasty or rhinoplasty. The primary outcome is the time from sugammadex administration to recovery of a train-of-four (TOF) ratio of 0.9. Secondary outcomes include extubation time, postoperative nausea and vomiting (PONV), pain scores, complications in the post-anesthesia care unit (PACU), and intraoperative hemodynamic parameters. The study will provide new evidence on whether perioperative corticosteroid choice modifies the efficacy of sugammadex and influences postoperative recovery.
Read the detailed description
Neuromuscular blockade with rocuronium is routinely reversed with sugammadex. Corticosteroids such as methylprednisolone and dexamethasone are frequently used perioperatively for their anti-inflammatory and antiemetic effects. However, possible pharmacological interactions between corticosteroids and sugammadex remain unclear and may affect reversal time.
This prospective, randomized, parallel-group clinical trial will enroll adult ASA I-II patients scheduled for elective septoplasty or rhinoplasty. Patients will be randomized to receive either methylprednisolone (1 mg/kg IV) or dexamethasone (0.2 mg/kg IV) at induction of anesthesia. Rocuronium will be administered for neuromuscular blockade, and sugammadex (2 mg/kg IV) will be given at the reappearance of the second twitch in TOF monitoring. Neuromuscular recovery will be continuously assessed with acceleromyography at the adductor pollicis muscle.
The primary outcome is the time interval from sugammadex injection to a TOF ratio of 0.9.
Secondary outcomes include extubation time, total rocuronium consumption, incidence and severity of PONV (assessed by VAS-B at 0, 30, 60, and 120 minutes in PACU), postoperative pain (VAS-A at the same time points), PACU complications (desaturation, stridor, severe cough), and intraoperative hemodynamic variables.
All anesthetic procedures will be standardized, and outcome assessors and statisticians will be blinded to group allocation. The results of this trial may guide perioperative steroid selection in patients receiving sugammadex reversal and help optimize postoperative recovery.
- Conditions
- Neuromuscular Block, Residual, Pain, Postoperative Nausea
- Being tested
- Methylprednisolone (MP), Dexamethasone
- Keywords
- sugammadex, dexamethasone, methylprednisolone, postoperative nausea, postoperative pain
- Medical subject headings
- Delayed Emergence from Anesthesia, Pain, 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.
Methylprednisolone (MP)Drug
Methylprednisolone 1 mg/kg IV (diluted to 5 mL with saline) will be administered at induction of anesthesia. Neuromuscular blockade will be achieved with rocuronium. Reversal will be performed with sugammadex 2 mg/kg IV at the reappearance of the second twitch in train of four monitoring.
DexamethasoneDrug
Dexamethasone 0.2 mg/kg IV (diluted to 5 mL with saline) will be administered at induction of anesthesia. Neuromuscular blockade will be achieved with rocuronium. Reversal will be performed with sugammadex 2 mg/kg IV at the reappearance of second twitch in train of four monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone Group | Active comparator | Patients will receive intravenous methylprednisolone 1 mg/kg diluted in 5 mL saline, administered at anesthesia induction.
Neuromuscular blockade will be achieved with rocuronium.
Reversal will be performed with sugammadex 2 mg/kg at reappearance of the second twitch in train of four monitoring. Receives: Drug: Methylprednisolone (MP) |
| Dexamethasone Group | Active comparator | Patients will receive intravenous dexamethasone 0.2 mg/kg diluted in 5 mL saline, administered at anesthesia induction.
Neuromuscular blockade will be achieved with rocuronium.
Reversal will be performed with sugammadex 2 mg/kg at reappearance of second twitch in train of four monitoring Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal Time
The interval in seconds between intravenous administration of sugammadex (2 mg/kg) and achievement of a normalised train-of-four ratio ≥0.9 measured at the adductor pollicis muscle using acceleromyography.
Measured: Perioperative period (Immediately after sugammadex administration until achievement of a normalised train-of-four ratio ≥0.9, measured in seconds)
Secondary outcomes (3)
Extubation time
Time in minutes from sugammadex injection to tracheal extubation in perioperative period.
Measured: Perioperative period (from sugammadex administration until tracheal extubation, in minutes)
Postoperative pain scores
Pain intensity assessed with Visual Analogue Scale for Pain (VAS-A; 0-10 scale).
Measured: At 2 hours postoperatively
Postoperative nausea and vomiting (PONV) incidence and severity
Presence and severity of nausea and vomiting, assessed using Visual Analogue Scale for Nausea and Vomiting (VAS-B; 0-10 scale).
Measured: At 2 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
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
- NCT07187037
- Sponsor's protocol ID
- AEŞH-EK-2025- 100
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zwiers A, van den Heuvel M, Smeets J, Rutherford S. Assessment of the potential for displacement interactions with sugammadex: a pharmacokinetic-pharmacodynamic modelling approach. Clin Drug Investig. 2011;31(2):101-11. doi: 10.2165/11584730-000000000-00000.
PubMed 21067251Fortier LP, McKeen D, Turner K, de Medicis E, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.
PubMed 25902322
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 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 Adult Patients
- ClinicalTrials.gov ID
- NCT07187037
- Acronym / sponsor ID
- AEŞH-EK-2025- 100
- Conditions
- Neuromuscular Block, Residual, Pain, Postoperative Nausea
- Keywords
- sugammadex, dexamethasone, methylprednisolone, postoperative nausea, postoperative pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 22 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 effects of intravenous methylprednisolone and dexamethasone on the reversal time of rocuronium by sugammadex in adult patients undergoing elective septoplasty or rhinoplasty. The primary outcome is the time from sugammadex administration to recovery of a train-of-four (TOF) ratio of 0.9. Secondary outcomes include extubation time, postoperative nausea and vomiting (PONV), pain scores, complications in the post-anesthesia care unit (PACU), and intraoperative hemodynamic parameters. The study will provide new evidence on whether perioperative corticosteroid choice modifies the efficacy of sugammadex and influences postoperative recovery.
Detailed description
Neuromuscular blockade with rocuronium is routinely reversed with sugammadex. Corticosteroids such as methylprednisolone and dexamethasone are frequently used perioperatively for their anti-inflammatory and antiemetic effects. However, possible pharmacological interactions between corticosteroids and sugammadex remain unclear and may affect reversal time.
This prospective, randomized, parallel-group clinical trial will enroll adult ASA I-II patients scheduled for elective septoplasty or rhinoplasty. Patients will be randomized to receive either methylprednisolone (1 mg/kg IV) or dexamethasone (0.2 mg/kg IV) at induction of anesthesia. Rocuronium will be administered for neuromuscular blockade, and sugammadex (2 mg/kg IV) will be given at the reappearance of the second twitch in TOF monitoring. Neuromuscular recovery will be continuously assessed with acceleromyography at the adductor pollicis muscle.
The primary outcome is the time interval from sugammadex injection to a TOF ratio of 0.9.
Secondary outcomes include extubation time, total rocuronium consumption, incidence and severity of PONV (assessed by VAS-B at 0, 30, 60, and 120 minutes in PACU), postoperative pain (VAS-A at the same time points), PACU complications (desaturation, stridor, severe cough), and intraoperative hemodynamic variables.
All anesthetic procedures will be standardized, and outcome assessors and statisticians will be blinded to group allocation. The results of this trial may guide perioperative steroid selection in patients receiving sugammadex reversal and help optimize postoperative recovery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone Group | Active comparator | Drug: Methylprednisolone (MP)Patients will receive intravenous methylprednisolone 1 mg/kg diluted in 5 mL saline, administered at anesthesia induction. Neuromuscular blockade will be achieved with rocuronium. Reversal will be performed with sugammadex 2 mg/kg at reappearance of the second twitch in train of four monitoring. |
| Dexamethasone Group | Active comparator | Drug: DexamethasonePatients will receive intravenous dexamethasone 0.2 mg/kg diluted in 5 mL saline, administered at anesthesia induction. Neuromuscular blockade will be achieved with rocuronium. Reversal will be performed with sugammadex 2 mg/kg at reappearance of second twitch in train of four monitoring |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18-65 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective septoplasty or rhinoplasty under general anesthesia
- Written informed consent obtained
Key exclusion criteria (10 listed)
- ASA physical status ≥ III
- Emergency surgery
- Known allergy or contraindication to rocuronium, sugammadex, or corticosteroids
- Chronic or recent (within 3 months) systemic corticosteroid therapy
- Concomitant use of drugs that may interact with sugammadex (e.g., toremifene, flucloxacillin, fusidic acid)
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 |
|---|---|---|
| Methylprednisolone (MP)Methylprednisolone 1 mg/kg IV (diluted to 5 mL with saline) will be administered at induction of anesthesia. Neuromuscular blockade will be achieved with rocuronium. Reversal will be performed with sugammadex 2 mg/kg IV at the reappearance of the second twitch in train of four monitoring. | Drug | Methylprednisolone Group |
| DexamethasoneDexamethasone 0.2 mg/kg IV (diluted to 5 mL with saline) will be administered at induction of anesthesia. Neuromuscular blockade will be achieved with rocuronium. Reversal will be performed with sugammadex 2 mg/kg IV at the reappearance of second twitch in train of four monitoring. | Drug | Dexamethasone Group |
Primary outcome
Reversal Time
Time frame: Perioperative period (Immediately after sugammadex administration until achievement of a normalised train-of-four ratio ≥0.9, measured in seconds)
The interval in seconds between intravenous administration of sugammadex (2 mg/kg) and achievement of a normalised train-of-four ratio ≥0.9 measured at the adductor pollicis muscle using acceleromyography.
3 secondary outcomes
Extubation time
Time frame: Perioperative period (from sugammadex administration until tracheal extubation, in minutes)
Postoperative pain scores
Time frame: At 2 hours postoperatively
Postoperative nausea and vomiting (PONV) incidence and severity
Time frame: At 2 hours postoperatively
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 22 Sep 2025.
- Background: PubMed 21067251Zwiers A, van den Heuvel M, Smeets J, Rutherford S. Assessment of the potential for displacement interactions with sugammadex: a pharmacokinetic-pharmacodynamic modelling approach. Clin Drug Investig. 2011;31(2):101-11. doi: 10.2165/11584730-000000000-00000.
- Background: PubMed 25902322Fortier LP, McKeen D, Turner K, de Medicis E, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.
- 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?
A study testing Methylprednisolone (MP) and Dexamethasone in people with Neuromuscular Block, Residual and Pain, run by Konya City Hospital 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 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: opening soon, as of the sponsor's last update on 22 Sep 2025. 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 MUSTAFA BÜYÜKCAVLAK, MD (+905064733392, mustafabcavlak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reversal Time (time frame: Perioperative period (Immediately after sugammadex administration until achievement of a normalised train-of-four ratio ≥0.9, measured 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 NCT07187037, which also lists 2 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 22 Sep 2025.