Efficacy of Dexmedetomidine for Cough Suppression in Patients Undergoing Thyroid Surgery

Study Overview
=================
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.

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

Conditions
-----------------
Anesthesia Complication

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine Hydrochloride
* Drug: Normal Saline
* Drug: Dexmedetomidine Hydrochloride
* Drug: Dexmedetomidine Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30Kg/m2 ≥ BMI > 18Kg/m2; undergoing general anesthesia; ASA physical status I and II undergoing elective thyroid surgery. Exclusion Criteria: hyperthyroidism; preoperative bradycardia; liver function impairment; renal function impairment; heart function failure; history of asthma or COPD; history of diabetes; cognition function impairment; pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine low dose group<br>Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.2μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery | Drug: Dexmedetomidine Hydrochloride<br>* 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<br>|
| Experimental: Dexmedetomidine median dose group<br>Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.5μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery | Drug: Dexmedetomidine Hydrochloride<br>* 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<br>|
| Experimental: Dexmedetomidine high dose group<br>Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.7μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery | Drug: Dexmedetomidine Hydrochloride<br>* 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<br>|
| Placebo Comparator: Control group (normal saline group)<br>Patients in this group are received saline iv infusion of 5mL·h-1 from incision to 20-30 minutes before the end of surgery | Drug: Normal Saline<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of coughing during anesthetic emergence | incidence of coughing within 10 minutes after extubation | within 10 minutes after endotracheal extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Ramsay score during anesthetic emergence | Ramsay score 1min, 5min, 10min, and 30min after extubation | within 30 minutes after endotracheal extubation | 
| Bruggrmann comfort scale score | Bruggrmann comfort scale score 30min and 24 hrs after extubation | within 24 hrs after endotracheal extubation | 
| VAS pain score | VAS pain score 30min, 24 hrs and 48 hrs after extubation | within 48 hrs after endotracheal extubation | 
| Respiratory rate (RR) | Respiratory rate 1min, 5min, 10min, and 30min after extubation | within 30min after endotracheal extubation | 
| Heart rate | Heart rate 1min, 5min, 10min, and 30min after extubation | within 30 minutes after endotracheal extubation | 
| mean arterial pressure | Mean arterial pressure 1min, 5min, 10min, and 30min after extubation | within 30 minutes after endotracheal extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dexmedetomidine, coughing during anesthetic emergence, thyroid surgery