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

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

Study Overview

• Status: Completed
• Conditions: Adults Undergoing Otorhinolaryngology Surgery
• Intervention / Treatment: Drug: Magnesium sulphate; Drug: Dexmedetomidine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo Central National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnesium Sulphate; 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; 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
Active Comparator: Dexmedetomidine; 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: emergence agitation; dexmedetomidine; Adult; magnesium sulphate; otorhinolaryngology
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Inorganic Chemicals; Sulfur Acids; Sulfates; Sulfuric Acids; Magnesium Compounds; Dexmedetomidine; Magnesium Sulfate
• Other Study ID Numbers: IndonesiaU260226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No