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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Sulphate | Experimental | Participants receive continuous intravenous magnesium sulphate infusion administered intraoperatively from induction of anesthesia until the end of surgery as part of standardized general anesthesia management. |
|
| Dexmedetomidine | Active Comparator | Participants receive continuous intravenous dexmedetomidine infusion administered intraoperatively from induction of anesthesia until the end of surgery as part of standardized general anesthesia management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Experiencing Emergence Agitation | 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. | From discontinuation of anesthetic agents until discharge from the post-anesthesia care unit (PACU), up to approximately 1 hour post-extubation. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Emergence Agitation | Severity of agitation assessed using the Richmond Agitation-Sedation Scale (RASS). Severe agitation defined as RASS ≥ 3 during the early recovery phase. | From discontinuation of anesthetic agents until discharge from PACU, up to approximately 1 hour post-extubation. |
| Onset of Emergence Agitation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo Central National Hospital | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 26, 2026 |
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|
|
| 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. |
|
Time interval between discontinuation of anesthetic agents and first documented RASS score ≥ 2. |
| uring the early recovery period, up to approximately 1 hour post-extubation. |
| Duration of Emergence Agitation | Time interval from first documented RASS ≥ 2 until RASS < 2 is achieved. | During the early recovery period, up to approximately 1 hour post-extubation. |
| Mean Arterial Pressure | Serial measurements of mean arterial pressure (MAP) recorded at predefined perioperative time points to evaluate temporal trends and drug-time interaction. | From baseline (pre-induction) until 1 hour postoperatively. |
| Heart Rate | Serial measurements of heart rate (HR) recorded at predefined perioperative time points to evaluate temporal trends and drug-time interaction. | From baseline (pre-induction) until 1 hour postoperatively. |
| Postoperative Pain | Pain intensity assessed using a numeric rating scale (0-10). | During PACU stay (up to approximately 1 hour post-extubation). |
| Extubation Time | Time from discontinuation of anesthetic agents to fulfillment of extubation criteria and removal of endotracheal tube. | From cessation of anesthetic agents until extubation during the immediate recovery phase, up to approximately 1 hour post-extubation. |
| Apr 15, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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