The Effect of Methylprednisolone on the… | Clinical Trial

Key information

Conditions

Sugammadex Reversal Time Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Konya City Hospital

Konya, 42050, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who are able to provide informed consent and reliably report symptoms to the research team,
Classified as Physical Status 1 and 2 according to the American Society of Anesthesiologists (ASA).

Exclusion criteria

Patients for whom parental or personal consent could not be obtained
ASA Physical Status 3 or higher
Known history of allergic reactions to the drugs specified in the protocol
Patients requiring emergency surgery
Expected difficult airway
Preoperative corticosteroid use
Presence of respiratory system diseases
Presence of neuromuscular diseases
Presence of enzymatic or endocrine disorders
Presence of liver or kidney failure
Presence of cardiovascular diseases
Patients with abnormal cognitive or physical development
History of treatment with drugs that have a high potential for interaction with sugammadex (e.g., toremifene, flucloxacillin, fusidic acid).

Treatment and study plan

methylprednisolone

Drug

Patients will undergo standard noninvasive blood pressure monitoring, electrocardiogram, peripheral oxygen saturation (SpO2), and capnography. After anesthesia induction, neuromuscular monitoring will also be applied. Anesthesia induction will be performed with 2-4 mg/kg propofol and 1 mcg/kg fentanyl. First group (Group M), patients will receive 1 mg/kg methylprednisolone , while in the second group (Group C), patients will receive 5 ml of normal saline. Immediately afterward, the neuromuscular monitor will be set to measure the Train of Four (TOF). Following this, 0.6-1.2 mg/kg of rocuronium will be administered intravenously. If necessary, additional doses of 0.15 mg/kg rocuronium will be given during the operation when TOF count reaches T2. For postoperative analgesia, 15 mg/kg of i.v. paracetamol will be administered. At the end of the surgery, when anesthesia is terminated and T2 reappears in TOF count, all patients will receive a single bolus injection of sugammadex.

Saline (NaCl 0,9 %) (placebo)

Other

Patients will undergo standard noninvasive blood pressure monitoring, electrocardiogram, peripheral oxygen saturation (SpO2), and capnography. After anesthesia induction, neuromuscular monitoring will also be applied. Anesthesia induction will be performed with 2-4 mg/kg propofol and 1 mcg/kg fentanyl. First group (Group M), patients will receive 1 mg/kg methylprednisolone , while in the second group (Group C), patients will receive 5 ml of normal saline. Immediately afterward, the neuromuscular monitor will be set to measure the Train of Four (TOF). Following this, 0.6-1.2 mg/kg of rocuronium will be administered intravenously. If necessary, additional doses of 0.15 mg/kg rocuronium will be given during the operation when TOF count reaches T2. For postoperative analgesia, 15 mg/kg of i.v. paracetamol will be administered. At the end of the surgery, when anesthesia is terminated and T2 reappears in TOF count, all patients will receive a single bolus injection of sugammadex.

Primary outcomes

reversal time

Time frame: The study will conclude after the patient has been postoperatively monitored for 2 hours in the recovery unit

The time to reach a TOF ratio of 0.9 after sugammadex administration and the time until extubation will be recorded for all patients.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

The Effect of Methylprednisolone Administration on the Reversal Time of Rocuronium by Sugammadex in the Pediatric Patient Group

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 2, 2024
Registry last updated: Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed