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

NCT07544173 | Completed Phase 4

• 1 other identifier: IndonesiaU260226
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adults Undergoing Otorhinolaryngology Surgery

Keywords

Adult; dexmedetomidine; emergence agitation; magnesium sulphate; otorhinolaryngology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Severity of Emergence Agitation

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

• Onset of Emergence Agitation

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

• Duration of Emergence Agitation

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

• Mean Arterial Pressure

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

• Heart Rate

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

Study Arms (2)

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.

Drug: Magnesium sulphate

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.

Drug: Dexmedetomidine

Interventions

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.

Also known as: MgSO4

Magnesium Sulphate

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.

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Magnesium Sulfate; Dexmedetomidine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neuroanesthesiologist

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: January 1, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-02

Locations

ID (1)