Neuromuscular Block, Residual, Pain, Postoperative Nausea
Conditions
Keywords
sugammadex, dexamethasone, methylprednisolone, postoperative nausea, postoperative pain
Brief 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. 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.
Interventions
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.
DRUGDexamethasone
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.
Sponsors
Konya City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reversal Time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extubation time | Perioperative period (from sugammadex administration until tracheal extubation, in minutes) | Time in minutes from sugammadex injection to tracheal extubation in perioperative period. |
| Postoperative pain scores | At 2 hours postoperatively | Pain intensity assessed with Visual Analogue Scale for Pain (VAS-A; 0-10 scale). |
| Postoperative nausea and vomiting (PONV) incidence and severity | At 2 hours postoperatively | Presence and severity of nausea and vomiting, assessed using Visual Analogue Scale for Nausea and Vomiting (VAS-B; 0-10 scale). |
Countries
Turkey (Türkiye)
Contacts
Primary ContactMUSTAFA BÜYÜKCAVLAK, MD
Outcome results
None listed