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Efficacy of Dexmedetomidine for Cough Suppression in Patients Undergoing Thyroid Surgery

Efficacy of Dexmedetomidine for Cough Suppression During Anesthetic Emergence in Patients Undergoing Thyroid Surgery: A Randomized, Double Blinded, Controlled Trial

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03312413
Acronym
EDCSTS
Enrollment
400
Registered
2017-10-17
Start date
2017-08-10
Completion date
2018-12-31
Last updated
2017-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Complication

Keywords

dexmedetomidine, coughing during anesthetic emergence, thyroid surgery

Brief summary

Maintenance of a remifentanil infusion during anesthetic emergence has been reported to decrease the incidence of coughing and thereby help to ensure a smooth emergence. It may, however, cause respiratory depression and possibly delay emergence. The purpose of this study was to investigate the effect of different dose of dexmedetomidine infusion on cough suppression during emergence from general anesthesia in patients undergoing thyroid surgery. American Society of Anesthesiologists physical status I-II adults undergoing elective thyroidectomy under general anesthesia are recruited and randomly allocated to receive dexmedetomidine iv infusion of 0.2μg·kg-1·h-1 (Group D1, n = 100), 0.5μg·kg-1·h-1 (Group D2, n = 100), 0.7μg·kg-1·h-1 (Group D3, n = 100) or saline (Group C, n = 100). Primary outcome is the incidence of coughing during emergence. Second outcomes include severity of coughing, which is assessed using a four-point scale; Ramsay score, Bruggrmann comfort scale score, VAS pain score are recorded. The respiratory rate (RR), heart rate (HR), and mean arterial pressure are also recorded.

Interventions

DRUGDexmedetomidine Hydrochloride

Dexmedetomidine Hydrochloride 0.2 μg·kg-1·h-will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery

DRUGNormal Saline

Normal saline 0.5 mL·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery

Sponsors

Min Su
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. 30Kg/m2 ≥ BMI \> 18Kg/m2; 2. undergoing general anesthesia; 3. ASA physical status I and II 4. undergoing elective thyroid surgery.

Exclusion criteria

1. hyperthyroidism; 2. preoperative bradycardia; 3. liver function impairment; 4. renal function impairment; 5. heart function failure; 6. history of asthma or COPD; 7. history of diabetes; 8. cognition function impairment; 9. pregnant or lactating women

Design outcomes

Primary

MeasureTime frameDescription
Incidence of coughing during anesthetic emergencewithin 10 minutes after endotracheal extubationincidence of coughing within 10 minutes after extubation

Secondary

MeasureTime frameDescription
Ramsay score during anesthetic emergencewithin 30 minutes after endotracheal extubationRamsay score 1min, 5min, 10min, and 30min after extubation
Bruggrmann comfort scale scorewithin 24 hrs after endotracheal extubationBruggrmann comfort scale score 30min and 24 hrs after extubation
VAS pain scorewithin 48 hrs after endotracheal extubationVAS pain score 30min, 24 hrs and 48 hrs after extubation
Ccoughing on a four-point scale during anesthetic emergencewithin 10 minutes after endotracheal extubationEvaluate the severity of coughing within 10 minutes after extubation by a four-point scale
Heart ratewithin 30 minutes after endotracheal extubationHeart rate 1min, 5min, 10min, and 30min after extubation
mean arterial pressurewithin 30 minutes after endotracheal extubationMean arterial pressure 1min, 5min, 10min, and 30min after extubation
Respiratory rate (RR)within 30min after endotracheal extubationRespiratory rate 1min, 5min, 10min, and 30min after extubation

Countries

China

Contacts

Primary ContactSU Min, M.D.
ms89011068@163.com86-23-89011068

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026