Efficacy of Dexmedetomidine for Cough Suppression in Patients Undergoing Thyroid Surgery

Anesthesia Complication Clinical Trial

— EDCSTS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03312413
• Other study ID #: CYYY2017
• Status: Recruiting
• Phase: Phase 4
• First received: September 4, 2017
• Last updated: October 12, 2017
• Start date: August 10, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2017
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: SU Min, M.D.
• Phone: 86-23-89011068
• Email: ms89011068[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Complication

Intervention

Drug:
• Dexmedetomidine 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
• Normal 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
• Dexmedetomidine Hydrochloride
Dexmedetomidine Hydrochloride 0.5 µg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
• Dexmedetomidine Hydrochloride
Dexmedetomidine Hydrochloride 0.7 µg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery

Locations

Country	Name	City	State
China	China,Chongqing The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Min Su

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of coughing during anesthetic emergence	incidence of coughing within 10 minutes after extubation	within 10 minutes after endotracheal extubation
Secondary	Ccoughing on a four-point scale during anesthetic emergence	Evaluate the severity of coughing within 10 minutes after extubation by a four-point scale	within 10 minutes after endotracheal extubation
Secondary	Ramsay score during anesthetic emergence	Ramsay score 1min, 5min, 10min, and 30min after extubation	within 30 minutes after endotracheal extubation
Secondary	Bruggrmann comfort scale score	Bruggrmann comfort scale score 30min and 24 hrs after extubation	within 24 hrs after endotracheal extubation
Secondary	VAS pain score	VAS pain score 30min, 24 hrs and 48 hrs after extubation	within 48 hrs after endotracheal extubation
Secondary	Respiratory rate (RR)	Respiratory rate 1min, 5min, 10min, and 30min after extubation	within 30min after endotracheal extubation
Secondary	Heart rate	Heart rate 1min, 5min, 10min, and 30min after extubation	within 30 minutes after endotracheal extubation
Secondary	mean arterial pressure	Mean arterial pressure 1min, 5min, 10min, and 30min after extubation	within 30 minutes after endotracheal extubation