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NCT Number: NCT07544173

Intravenous Magnesium Sulphate Versus Dexmedetomidine for Prevention of Emergence Agitation in Adult Otorhinolaryngologic Surgery

The goal of this clinical trial is to learn whether intravenous magnesium sulphate can reduce emergence agitation as effectively as intravenous dexmedetomidine in adult patients undergoing otorhinolaryngology surgery under general anesthesia.

The main questions it aims to answer are:

- Is intravenous magnesium sulphate non-inferior to intravenous - dexmedetomidine in reducing the proportion of emergence agitation (defined as Richmond Agitation-Sedation Scale [RASS] ≥2)? Are there differences between the two drugs in terms of hemodynamic stability, severity, onset and duration of emergence agitation, and recovery profile? Researchers will compare continuous intravenous magnesium sulphate infusion (20 mg/kg/hour) with continuous intravenous dexmedetomidine infusion (0.5 µg/kg/hour) to see if magnesium sulphate provides similar protection against emergence agitation with fewer hemodynamic side effects.

Participants will:

* Be randomized to receive either magnesium sulphate or dexmedetomidine infusion from induction of anesthesia until the end of surgery. * Undergo standardized general anesthesia with sevoflurane, fentanyl, and rocuronium. * Be assessed for emergence agitation using the Richmond Agitation-Sedation Scale (RASS) after discontinuation of anesthetic agents. * Have intraoperative heart rate, mean arterial pressure, anesthetic consumption, and vasoactive drug use recorded. * Be evaluated postoperatively for pain, opioid requirement, and extubation time.

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Key information

Conditions

Adults Undergoing Otorhinolaryngology Surgery Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

This multicenter, double-blinded, randomized controlled trial was designed to evaluate two intraoperative pharmacologic strategies used during general anesthesia for adult otorhinolaryngologic surgery.

The study is based on differing pharmacodynamic mechanisms: dexmedetomidine provides central sympatholysis via selective α2-adrenergic receptor activation, while magnesium sulphate modulates neuronal excitability primarily through NMDA receptor antagonism and calcium channel blockade. Both agents are administered as continuous infusions during surgery without a loading dose to allow steady-state effects and minimize abrupt hemodynamic changes.

Randomization is performed using a computer-generated sequence with allocation concealment. Study medications are prepared by independent pharmacy personnel in identical syringes to maintain blinding of anesthesia providers, patients, and investigators. Perioperative anesthetic management is standardized across sites to reduce variability in clinical practice.

Physiologic parameters are recorded at predefined perioperative intervals using structured case report forms. Data are analyzed using appropriate statistical methods based on distribution characteristics, including longitudinal modeling to account for repeated intra-subject measurements. A two-sided significance threshold is prespecified for all analyses.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients aged 18-70 years
  • ASA physical status I or II
  • Undergoing elective otorhinolaryngology surgery under general anesthesia
  • Willing to participate and provide informed consent

Exclusion criteria

  • Pregnant patients
  • Severe cognitive impairment
  • Known allergy to study drugs
  • Contraindications to study drugs (atrioventricular block, sinoatrial node dysfunction, renal failure)
  • Neuromuscular disorders
  • Regular use of beta-blockers or clonidine
  • Not extubated in the operating room or post-anesthesia care unit after procedure
  • Body mass index (BMI) ≥ 40

Treatment and study plan

Magnesium sulphate

Drug

Continuous intravenous magnesium sulphate infusion administered intraoperatively at a rate of 20 mg/kg/hour (based on total body weight) starting at induction of anesthesia and continued until completion of surgery. The drug is diluted in normal saline to a standardized total volume and infused under blinded conditions as part of standardized general anesthesia management.

Other names: MgSO4

Dexmedetomidine

Drug

Continuous intravenous dexmedetomidine infusion administered intraoperatively at a rate of 0.5 micrograms/kg/hour (based on total body weight) starting at induction of anesthesia and continued until completion of surgery. The drug is diluted in normal saline to a standardized total volume and infused under blinded conditions as part of standardized general anesthesia management.

Primary outcomes

  1. Proportion of Patients Experiencing Emergence Agitation

    Time frame: From discontinuation of anesthetic agents until discharge from the post-anesthesia care unit (PACU), up to approximately 1 hour post-extubation.

    Emergence agitation defined as Richmond Agitation-Sedation Scale (RASS) score ≥ 2 during the early recovery phase following discontinuation of anesthetic agents. Assessment performed by trained blinded assessors in the operating room and post-anesthesia care unit.

Secondary outcomes

  1. Severity of Emergence Agitation

    Time frame: From discontinuation of anesthetic agents until discharge from PACU, up to approximately 1 hour post-extubation.

    Severity of agitation assessed using the Richmond Agitation-Sedation Scale (RASS). Severe agitation defined as RASS ≥ 3 during the early recovery phase.

  2. Onset of Emergence Agitation

    Time frame: uring the early recovery period, up to approximately 1 hour post-extubation.

    Time interval between discontinuation of anesthetic agents and first documented RASS score ≥ 2.

  3. Duration of Emergence Agitation

    Time frame: During the early recovery period, up to approximately 1 hour post-extubation.

    Time interval from first documented RASS ≥ 2 until RASS < 2 is achieved.

  4. Mean Arterial Pressure

    Time frame: From baseline (pre-induction) until 1 hour postoperatively.

    Serial measurements of mean arterial pressure (MAP) recorded at predefined perioperative time points to evaluate temporal trends and drug-time interaction.

  5. Heart Rate

    Time frame: From baseline (pre-induction) until 1 hour postoperatively.

    Serial measurements of heart rate (HR) recorded at predefined perioperative time points to evaluate temporal trends and drug-time interaction.

  6. Postoperative Pain

    Time frame: During PACU stay (up to approximately 1 hour post-extubation).

    Pain intensity assessed using a numeric rating scale (0-10).

  7. Extubation Time

    Time frame: From cessation of anesthetic agents until extubation during the immediate recovery phase, up to approximately 1 hour post-extubation.

    Time from discontinuation of anesthetic agents to fulfillment of extubation criteria and removal of endotracheal tube.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Comparison on the Effectiveness of Intravenous Magnesium Sulphate and Intravenous Dexmedetomidine in Reducing Emergence Agitation in Adults Undergoing Otorhinolaryngology Surgery

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

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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