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

NCT ID: NCT07187037

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-04-30

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.

Conditions

Neuromuscular Block, Residual; Pain; Postoperative Nausea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Methylprednisolone Group

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.

Group Type: ACTIVE_COMPARATOR

Methylprednisolone (MP)

Intervention Type: 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 Group

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

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Dexamethasone

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Konya City Hospital

OTHER

Sponsor Role: lead

Responsible Party

MUSTAFA BÜYÜKCAVLAK

Specialist in Anesthesiology and Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Konya City Hospital

Karatay, Konya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

MUSTAFA BÜYÜKCAVLAK, MD

Role: CONTACT

mustafabcavlak@gmail.com

+905064733392

Facility Contacts

MUSTAFA BÜYÜKCAVLAK, MD

Role: primary

mustafabcavlak@gmail.com

05064733392

References

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.

Reference Type: BACKGROUND

PMID: 21067251 (View on PubMed)

Fortier 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.

Reference Type: BACKGROUND

PMID: 25902322 (View on PubMed)

Other Identifiers

AEŞH-EK-2025- 100

Identifier Type: -

Identifier Source: org_study_id