Clinical trial NCT03312413: Efficacy of Dexmedetomidine for Cough Suppression in Patients Undergoing Thyroid Surgery
Official title: Efficacy of Dexmedetomidine for Cough Suppression During Anesthetic Emergence in Patients Undergoing Thyroid Surgery: A Randomized, Double Blinded, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia Complication
Keywords: dexmedetomidine
coughing during anesthetic emergence
thyroid surgery
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of coughing during anesthetic emergence
timeFrame: within 10 minutes after endotracheal extubation
Secondary outcomes:
measure: Ccoughing on a four-point scale during anesthetic emergence
timeFrame: within 10 minutes after endotracheal extubation
measure: Ramsay score during anesthetic emergence
timeFrame: within 30 minutes after endotracheal extubation
measure: Bruggrmann comfort scale score
timeFrame: within 24 hrs after endotracheal extubation
measure: VAS pain score
timeFrame: within 48 hrs after endotracheal extubation
measure: Respiratory rate (RR)
timeFrame: within 30min after endotracheal extubation
measure: Heart rate
timeFrame: within 30 minutes after endotracheal extubation
measure: mean arterial pressure
timeFrame: within 30 minutes after endotracheal extubation
Other outcomes:
Locations:
city: Chongqing
country: China
facility: China,Chongqing The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References: