Adults Undergoing Otorhinolaryngology SurgeryPhase 4NCT07544173
Intravenous Magnesium Sulphate Versus Dexmedetomidine for Prevention of Emergence Agitation in Adult Otorhinolaryngologic Surgery
A Phase 4 study testing Magnesium sulphate and Dexmedetomidine in people with Adults Undergoing Otorhinolaryngology Surgery, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Adults Undergoing Otorhinolaryngology Surgery
- What is being tested?
- Magnesium sulphate and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2024to 1 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Central National Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Being tested
- Magnesium sulphate, Dexmedetomidine
- Keywords
- Adult, dexmedetomidine, emergence agitation, magnesium sulphate, otorhinolaryngology
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulphateDrug
Also called MgSO4
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.
DexmedetomidineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Severity of agitation assessed using the Richmond Agitation-Sedation Scale (RASS). Severe agitation defined as RASS ≥ 3 during the early recovery phase.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline (pre-induction) until 1 hour postoperatively.
Postoperative Pain
Pain intensity assessed using a numeric rating scale (0-10).
Measured: 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.
Measured: From cessation of anesthetic agents until extubation during the immediate recovery phase, up to approximately 1 hour post-extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 May 2024
- Primary completion31 Aug 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adults Undergoing Otorhinolaryngology SurgeryStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riyadh Firdaus, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544173
- Sponsor's protocol ID
- IndonesiaU260226
- Status last verified
- Feb 2026
- First submitted
- 2 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yunda GA, Firdaus R, Auerkari AN. Comparison on the Effectiveness of Intravenous Magnesium Sulphate and Intravenous Dexmedetomidine in Reducing Emergence Agitation in Adults Undergoing Otorhinolaryngology Surgery. Anesthesiol Res Pract. 2026 Jul 20;2026:5531396. doi: 10.1155/anrp/5531396. eCollection 2026.
PubMed 42518964
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison on the Effectiveness of Intravenous Magnesium Sulphate and Intravenous Dexmedetomidine in Reducing Emergence Agitation in Adults Undergoing Otorhinolaryngology Surgery
- ClinicalTrials.gov ID
- NCT07544173
- Acronym / sponsor ID
- IndonesiaU260226
- Keywords
- Adult, dexmedetomidine, emergence agitation, magnesium sulphate, otorhinolaryngology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulphate | Experimental | Drug: Magnesium sulphateParticipants 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 | Drug: DexmedetomidineParticipants receive continuous intravenous dexmedetomidine infusion administered intraoperatively from induction of anesthesia until the end of surgery as part of standardized general anesthesia management. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Pregnant patients
- Severe cognitive impairment
- Known allergy to study drugs
- Contraindications to study drugs (atrioventricular block, sinoatrial node dysfunction, renal failure)
- Neuromuscular disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulphateAlso: MgSO4Continuous 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. | Drug | Magnesium Sulphate |
| DexmedetomidineContinuous 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. | Drug | Dexmedetomidine |
Primary outcome
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.
7 secondary outcomes
Severity of Emergence Agitation
Time frame: From discontinuation of anesthetic agents until discharge from PACU, up to approximately 1 hour post-extubation.
Onset of Emergence Agitation
Time frame: uring the early recovery period, up to approximately 1 hour post-extubation.
Duration of Emergence Agitation
Time frame: During the early recovery period, up to approximately 1 hour post-extubation.
Mean Arterial Pressure
Time frame: From baseline (pre-induction) until 1 hour postoperatively.
Heart Rate
Time frame: From baseline (pre-induction) until 1 hour postoperatively.
Postoperative Pain
Time frame: During PACU stay (up to approximately 1 hour post-extubation).
Extubation Time
Time frame: From cessation of anesthetic agents until extubation during the immediate recovery phase, up to approximately 1 hour post-extubation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Derived from this study: PubMed 42518964Yunda GA, Firdaus R, Auerkari AN. Comparison on the Effectiveness of Intravenous Magnesium Sulphate and Intravenous Dexmedetomidine in Reducing Emergence Agitation in Adults Undergoing Otorhinolaryngology Surgery. Anesthesiol Res Pract. 2026 Jul 20;2026:5531396. doi: 10.1155/anrp/5531396. eCollection 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium sulphate and Dexmedetomidine in people with Adults Undergoing Otorhinolaryngology Surgery, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07544173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.