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Methylprednisolone vs Dexamethasone: Effects on Sugammadex Reversal, Pain, and Nausea in Adults

ConditionsNeuromuscular Block, ResidualPainPostoperative Nausea
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKonya City Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

ASA physical status ≥ III

Emergency surgery

Known allergy or contraindication to rocuronium, sugammadex, or corticosteroids

Chronic or recent (within 3 months) systemic corticosteroid therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Dexamethasone

    Drug

    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.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Methylprednisolone GroupActive comparator 1 intervention
Group B: Dexamethasone GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Perioperative period (Immediately after sugammadex administration until achievement of a normalised train-of-four ratio ≥0.9, measured in seconds)

Secondary outcomes

1

Extubation time

Time in minutes from sugammadex injection to tracheal extubation in perioperative period.

Time frame
Perioperative period (from sugammadex administration until tracheal extubation, in minutes)
2

Postoperative pain scores

Pain intensity assessed with Visual Analogue Scale for Pain (VAS-A; 0-10 scale).

Time frame
At 2 hours postoperatively
3

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).

Time frame
At 2 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Konya City Hospital

Lead sponsor

Source ClinicalTrials.gov

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