A Phase 4 interventional study of Magnesium sulphate and Dexmedetomidine in Adults Undergoing Otorhinolaryngology Surgery, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Indonesia University · Phase 4, Interventional, and Prevention
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.
763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.
This study's enrollment of 64 is below the median of 120 across 475 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
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.
Drug: Magnesium sulphate
Participants receive continuous intravenous dexmedetomidine infusion administered intraoperatively from induction of anesthesia until the end of surgery as part of standardized general anesthesia management.
Drug: Dexmedetomidine
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.
Also known as: MgSO4
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.
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.
Time frame: From discontinuation of anesthetic agents until discharge from the post-anesthesia care unit (PACU), up to approximately 1 hour post-extubation.
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.
Time frame: From discontinuation of anesthetic agents until discharge from PACU, up to approximately 1 hour post-extubation.
Onset of Emergence Agitation
Time interval between discontinuation of anesthetic agents and first documented RASS score ≥ 2.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline (pre-induction) until 1 hour postoperatively.
Postoperative Pain
Pain intensity assessed using a numeric rating scale (0-10).
Time frame: 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.
Time frame: From cessation of anesthetic agents until extubation during the immediate recovery phase, up to approximately 1 hour post-extubation.
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