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NOT YET RECRUITING
NCT07462195
PHASE4

Dexmedetomidine for Improving Emergence Quality in Thyroid Surgery

Sponsor: Bach Mai Hospital

View on ClinicalTrials.gov

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 until the post-anesthesia care unit (PACU), with an additional bolus before extubation, in patients undergoing 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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-03

Completion Date

2026-10

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

DRUG

Dexmedetomidine

Dexmedetomidine administered perioperatively as an anesthetic adjunct. A loading dose of 1 µg/kg is infused during induction of anesthesia, followed by continuous infusion at 0.5 µg/kg/h during surgery and continued into the post-anesthesia care unit (PACU). An additional bolus dose of 0.5 µg/kg is administered before extubation. 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.

PROCEDURE

Standard General Anesthesia

Standardized 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.