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RecruitingNCT07462195

Dexmedetomidine for Improving Emergence Quality in Thyroid Surgery

Effect of Perioperative Dexmedetomidine Infusion on Anesthetic Requirements and Quality of Emergence in Patients Undergoing Thyroid Surgery: A Randomized Controlled Trial

Status
Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Bach Mai Hospital · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Thyroid surgery requires smooth emergence from anesthesia to minimize coughing, hemodynamic fluctuations, and agitation during extubation, which may contribute to postoperative complications such as bleeding or cervical hematoma. Dexmedetomidine, a selective α2-adrenergic receptor agonist, has sedative, analgesic-sparing, and sympatholytic properties that may improve anesthetic stability and recovery quality. This randomized controlled trial aims to evaluate the effectiveness of a continuous perioperative dexmedetomidine regimen initiated at induction of anesthesia and maintained during thyroid surgery. The study will compare dexmedetomidine combined with standard balanced anesthesia versus standard anesthesia alone in terms of anesthetic requirements and emergence quality. The primary hypothesis is that perioperative dexmedetomidine administration reduces anesthetic and opioid requirements and improves emergence quality by decreasing coughing during extubation and hemodynamic responses.

Detailed description

Dexmedetomidine has been widely studied as an anesthetic adjunct due to its sedative and analgesic-sparing effects without significant respiratory depression. Previous randomized trials have demonstrated its ability to reduce coughing during extubation, attenuate sympathetic responses, and improve recovery quality after thyroid surgery. However, most studies have administered dexmedetomidine only during emergence or intraoperatively. This study investigates a comprehensive perioperative dexmedetomidine protocol consisting of: * A loading dose immediately before induction of anesthesia * Continuous infusion during surgery The aim is to assess whether this regimen improves intraoperative anesthetic efficiency and postoperative recovery quality. Patients scheduled for thyroid surgery under general anesthesia will be randomized to receive dexmedetomidine or standard anesthesia without dexmedetomidine. Standardized anesthetic techniques will be used for induction, maintenance, and postoperative care. Outcome measures include anesthetic requirements, opioid consumption, coughing at extubation, emergence agitation, hemodynamic responses, postoperative nausea and vomiting (PONV), and postoperative bleeding complications.

Conditions

Interventions

TypeNameDescription
DRUGDexmedetomidineDexmedetomidine administered perioperatively as an anesthetic adjunct. A loading dose of 1 µg/kg is infused immediately before induction of anesthesia (in 10 minutes), followed by continuous infusion at 0.5 µg/kg/h during surgery. Depth of anesthesia is monitored using bispectral index (BIS), and volatile anesthetic concentration is titrated to a target BIS range (40-60). Neuromuscular blockade is monitored using train-of-four (TOF) stimulation, and neuromuscular blocking agents are titrated accordingly, with extubation performed after standard neuromuscular recovery criteria are met.
PROCEDUREStandard General AnesthesiaStandardized balanced general anesthesia using intravenous induction with propofol, opioid analgesia, and neuromuscular blockade, followed by maintenance with inhalational anesthetic agents according to institutional practice. Depth of anesthesia is monitored using bispectral index (BIS), and volatile anesthetic concentration is titrated to a target BIS range (40-60). Neuromuscular blockade is monitored using train-of-four (TOF) stimulation, and neuromuscular blocking agents are titrated accordingly, with extubation performed after standard neuromuscular recovery criteria are met.

Timeline

Start date
2026-04-13
Primary completion
2026-10-31
Completion
2026-11-30
First posted
2026-03-10
Last updated
2026-04-15

Locations

1 site across 1 country: Vietnam

Source: ClinicalTrials.gov record NCT07462195. Inclusion in this directory is not an endorsement.