Adults Undergoing Otorhinolaryngology Surgery
Conditions
Keywords
Adult, dexmedetomidine, emergence agitation, magnesium sulphate, otorhinolaryngology
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.
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.
Interventions
DRUGMagnesium 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.
DRUGDexmedetomidine
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.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Experiencing Emergence Agitation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Emergence Agitation | From discontinuation of anesthetic agents until discharge from PACU, up to approximately 1 hour post-extubation. | Severity of agitation assessed using the Richmond Agitation-Sedation Scale (RASS). Severe agitation defined as RASS ≥ 3 during the early recovery phase. |
| Onset of Emergence Agitation | uring the early recovery period, up to approximately 1 hour post-extubation. | Time interval between discontinuation of anesthetic agents and first documented RASS score ≥ 2. |
| Duration of Emergence Agitation | During the early recovery period, up to approximately 1 hour post-extubation. | Time interval from first documented RASS ≥ 2 until RASS \< 2 is achieved. |
| Mean Arterial Pressure | From baseline (pre-induction) until 1 hour postoperatively. | Serial measurements of mean arterial pressure (MAP) recorded at predefined perioperative time points to evaluate temporal trends and drug-time interaction. |
| Heart Rate | From baseline (pre-induction) until 1 hour postoperatively. | Serial measurements of heart rate (HR) recorded at predefined perioperative time points to evaluate temporal trends and drug-time interaction. |
| Postoperative Pain | During PACU stay (up to approximately 1 hour post-extubation). | Pain intensity assessed using a numeric rating scale (0-10). |
| Extubation Time | From cessation of anesthetic agents until extubation during the immediate recovery phase, up to approximately 1 hour post-extubation. | Time from discontinuation of anesthetic agents to fulfillment of extubation criteria and removal of endotracheal tube. |
Countries
Indonesia
Outcome results
None listed