Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
ID07462195

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

Led by Bach Mai Hospital · Updated on 2026-04-15

100

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

B

Bach Mai Hospital

Lead Sponsor

H

Hanoi Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research investigates the use of dexmedetomidine, a drug with sedative and pain-reducing properties, to improve the quality of recovery after thyroid surgery. The study focuses on whether using dexmedetomidine throughout the surgery reduces the need for anesthesia and opioids and lessens coughing, agitation, and blood pressure changes during breathing tube removal. The trial takes place in patients aged 18 to 65 undergoing elective thyroid surgery under general anesthesia. Participants are randomly assigned to one of two groups: one receiving dexmedetomidine along with standard anesthesia, and the other receiving standard anesthesia alone. The dexmedetomidine group gets a loading dose before anesthesia induction followed by continuous infusion during surgery. Both groups have anesthesia managed with monitored techniques to maintain proper sedation and muscle relaxation until the breathing tube is safely removed. During the study, patients will be closely monitored for coughing during extubation, anesthetic and opioid use, agitation after waking, heart rate, blood pressure, pain levels, nausea, bleeding complications, and overall recovery quality. These assessments occur during surgery and up to 24 hours afterward. The total participation duration includes surgery and immediate postoperative care to evaluate the drug's impact on recovery.

CONDITIONS

Brief Title

Dexmedetomidine for Improving Emergence Quality in Thyroid Surgery

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-65 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective thyroid surgery under general anesthesia with endotracheal intubation
  • Able to understand the study procedures and provide written informed consent
Not Eligible

You will not qualify if you...

  • Known hypersensitivity or contraindication to dexmedetomidine or study-related medications
  • Clinically significant cardiac conduction abnormality or arrhythmia (e.g., second- or third-degree atrioventricular block without a pacemaker), severe bradyarrhythmia, or unstable cardiovascular disease
  • Severe hepatic dysfunction or severe renal failure
  • Pregnancy or breastfeeding
  • Planned postoperative ICU admission or postoperative deterioration requiring ICU admission
  • Major intraoperative complications such as major bleeding requiring urgent hemostatic intervention, tracheal or esophageal injury, or recurrent laryngeal nerve injury
  • Any condition that would interfere with outcome assessment or increase risk, such as inability to reliably report pain scores or complete quality of recovery questionnaires (QoR-15)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of surgery and immediate recovery (hours)

Participants undergo thyroid surgery under general anesthesia. They receive dexmedetomidine infusion perioperatively as an anesthetic adjunct or standard general anesthesia without dexmedetomidine during surgery.

1 perioperative visit (in-person)

Follow-up

Duration - 24 hours post-surgery

Participants are monitored for postoperative recovery quality, pain, nausea, vomiting, bleeding complications, and other outcomes within 24 hours after surgery.

Multiple assessments within 24 hours after surgery (in-person)

Trial Site Locations

Total: 1 location

1

Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital

Hanoi, Vietnam

Actively Recruiting

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Research Team

T

Thang Toan Nguyen, MD, PhD, Assoc Prof

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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