Effect of Dexmedetomidine After Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study was to compare the effect of dexmedetomidine which is administered during emergence in adult patients undergoing elective thyroidectomy on smooth emergence form general anesthesia (reducing agitation or coughing, signs of hypertension or tachycardia, or etc.) and postoperative outcome (postoperative bleeding and hospital staying).

Detailed Description
-----------------
Smooth emergence from general anaesthesia after surgery is important to prevent potentially dangerous effects such as hypertension, tachycardia, myocardial ischaemia, arrhythmias and increased intracranial and intra-abdominal pressure. After thyroidectomy, activities during emergence such as agitation or coughing, signs of hypertension or tachycardia, or etc. may lead to postoperative bleeding, resulting in acute airway obstruction or reoperation. The purpose of the present study was to compare the effect of dexmedetomidine which is administered during emergence in adult patients undergoing elective thyroidectomy on smooth emergence form general anesthesia and postoperative outcome.

Official Title
-----------------
Effect of Dexmedetomidine Infusion for Postoperative Outcome and Smooth Emergence After Thyroidectomy

Conditions
-----------------
Thyroid Tumor

Intervention / Treatment
-----------------
* Drug: Desflurane
* Drug: Remifentanil
* Procedure: Thyroidectomy
* Other: Vital signs
* Behavioral: Cough reflex
* Behavioral: Ramsay Sedation Scale
* Other: Extubation time and Recovery time
* Behavioral: Visual analogue scale
* Other: Postoperative bleeding
* Other: Postoperative complications
* Other: Time to remove drainage and duration of hospital staying
* Drug: Dexmedetomidine
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patient, Aged 20-60 yr, ASA physical status 1-2, Patients undergoing elective thyroidectomy under general anesthesia Exclusion Criteria: Sighs of difficult airway, History of respiratory disease or chronic cough, Cardiovascular disease, Pregnant or breast-feeding woman

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine (Group D)<br>After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3. | Drug: Desflurane<br>* Anesthesia is maintained with desflurane<br>* Other names: Anesthetic gas;Drug: Remifentanil<br>* Remifentanil is infused for the maintenance of anesthesia during surgery and discontinued 15 min before end of surgery<br>* Other names: Opioid;Procedure: Thyroidectomy<br>* The aim of this study is evaluation of effect of dexmedetomidine on emergence response and postoperative outcome after thyroidectomy<br>* Other names: Surgery;Other: Vital signs<br>* Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate are measured before infusion of testing drugs, after infusion of them (5 min, 10 min, and 15 min), during extubation (0 min and 5 min after extubation), and at recovery room. And the complications such as hypotension, hypertension, bradycardia, tachycardia, and desaturation after infusion of testing drugs are observed.<br>* Other names: Hemodynamics;Behavioral: Cough reflex<br>* During recovery from anesthesia at operation room, cough reflex is measured and rated. [Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking)]<br>Behavioral: Ramsay Sedation Scale<br>* When the patient has fully awaken and transferred to the recovery room, Ramsay Sedation Scale is measured. Awake Patient anxious and agitated or restless or both! Patient cooperative, oriented and tranquil! Patient responds to commands only! Asleep A brisk response to a light glabellar tap or loud auditory stimulus! A sluggish response to a light glabellar tap or loud auditory stimulus! No response to a light glabellar tap or loud auditory stimulus<br>* Other names: RSS;Other: Extubation time and Recovery time<br>* The time from discontinuing anesthetic gas to endotracheal extubation is measured. And the time from the discontinuing of anesthetic gas to transferring to the recovery room is also measured.<br>Behavioral: Visual analogue scale<br>* The severity of pain after surgery is measured by VAS (at recovery room, POD 1, POD 2, and POD 3)<br>* Other names: VAS;Other: Postoperative bleeding<br>* The amount of postoperative bleeding which is collected in the barovac is measured.<br>Other: Postoperative complications<br>* Postoperative complications after thyroidectomy such as hoarseness and hematoma, and reoperation due to such complication is observed.<br>Other: Time to remove drainage and duration of hospital staying<br>* The time from the end of surgery to remove drainage is measured. And the duration of hospital staying is measured.<br>Drug: Dexmedetomidine<br>* Dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr) before end of surgery as experimental intervention<br>* Other names: Precedex;|
| Placebo Comparator: Normal Saline (Group N)<br>After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3. | Drug: Desflurane<br>* Anesthesia is maintained with desflurane<br>* Other names: Anesthetic gas;Drug: Remifentanil<br>* Remifentanil is infused for the maintenance of anesthesia during surgery and discontinued 15 min before end of surgery<br>* Other names: Opioid;Procedure: Thyroidectomy<br>* The aim of this study is evaluation of effect of dexmedetomidine on emergence response and postoperative outcome after thyroidectomy<br>* Other names: Surgery;Other: Vital signs<br>* Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate are measured before infusion of testing drugs, after infusion of them (5 min, 10 min, and 15 min), during extubation (0 min and 5 min after extubation), and at recovery room. And the complications such as hypotension, hypertension, bradycardia, tachycardia, and desaturation after infusion of testing drugs are observed.<br>* Other names: Hemodynamics;Behavioral: Cough reflex<br>* During recovery from anesthesia at operation room, cough reflex is measured and rated. [Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking)]<br>Behavioral: Ramsay Sedation Scale<br>* When the patient has fully awaken and transferred to the recovery room, Ramsay Sedation Scale is measured. Awake Patient anxious and agitated or restless or both! Patient cooperative, oriented and tranquil! Patient responds to commands only! Asleep A brisk response to a light glabellar tap or loud auditory stimulus! A sluggish response to a light glabellar tap or loud auditory stimulus! No response to a light glabellar tap or loud auditory stimulus<br>* Other names: RSS;Other: Extubation time and Recovery time<br>* The time from discontinuing anesthetic gas to endotracheal extubation is measured. And the time from the discontinuing of anesthetic gas to transferring to the recovery room is also measured.<br>Behavioral: Visual analogue scale<br>* The severity of pain after surgery is measured by VAS (at recovery room, POD 1, POD 2, and POD 3)<br>* Other names: VAS;Other: Postoperative bleeding<br>* The amount of postoperative bleeding which is collected in the barovac is measured.<br>Other: Postoperative complications<br>* Postoperative complications after thyroidectomy such as hoarseness and hematoma, and reoperation due to such complication is observed.<br>Other: Time to remove drainage and duration of hospital staying<br>* The time from the end of surgery to remove drainage is measured. And the duration of hospital staying is measured.<br>Drug: Normal saline<br>* Normal saline has started infusion for 15 min (as same rate of dexmedetomidine) before end of surgery as control intervention<br>* Other names: NS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative bleeding | Postoperative bleeding: Sum of bleeding via barovac | From the end of surgery to the 3rd postoperative day (an expected average of 3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ramsay Sedation scale | Ramsay Sedation scale at recovery room | During the recovery time of anesthesia, an expected average of 20 min | 
| Extubation time | time to extubation from the end of surgery | During the recovery time of anesthesia, an expected average of 20 min | 
| Recovery time of anesthesia | time to transfer to recovery room from the end of surgery | During the recovery time of anesthesia, an expected average of 20 min | 
| Duration of hospital stay | Duration of hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 1 week | 
| Pain score | Pain score: NRS | From the end of surgery to the 3rd postoperative day (an expected average of 3 days) | 
| Incidence of postoperative complications | Hoarseness, hematoma, and reoperation | Participants will be followed for the duration of hospital stay, an expected average of 1 week | 
| Coughing Response | Coughing Response during recovery from anesthesia | During the recovery time of anesthesia, an expected average of 20 min |