Study Results
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Basic Information
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COMPLETED
NA
139 participants
INTERVENTIONAL
2014-04-30
2020-11-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Dexmedetomidine (Group D)
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.
Desflurane
Anesthesia is maintained with desflurane
Remifentanil
Remifentanil is infused for the maintenance of anesthesia during surgery and discontinued 15 min before end of surgery
Thyroidectomy
The aim of this study is evaluation of effect of dexmedetomidine on emergence response and postoperative outcome after thyroidectomy
Vital signs
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.
Cough reflex
During recovery from anesthesia at operation room, cough reflex is measured and rated. \[Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking)\]
Ramsay Sedation Scale
When the patient has fully awaken and transferred to the recovery room, Ramsay Sedation Scale is measured.
1. Awake Patient anxious and agitated or restless or both!
2. Patient cooperative, oriented and tranquil!
3. Patient responds to commands only!
4. Asleep A brisk response to a light glabellar tap or loud auditory stimulus!
5. A sluggish response to a light glabellar tap or loud auditory stimulus!
6. No response to a light glabellar tap or loud auditory stimulus
Extubation time and Recovery time
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.
Visual analogue scale
The severity of pain after surgery is measured by VAS (at recovery room, POD 1, POD 2, and POD 3)
Postoperative bleeding
The amount of postoperative bleeding which is collected in the barovac is measured.
Postoperative complications
Postoperative complications after thyroidectomy such as hoarseness and hematoma, and reoperation due to such complication is observed.
Time to remove drainage and duration of hospital staying
The time from the end of surgery to remove drainage is measured. And the duration of hospital staying is measured.
Dexmedetomidine
Dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr) before end of surgery as experimental intervention
Normal Saline (Group N)
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.
Desflurane
Anesthesia is maintained with desflurane
Remifentanil
Remifentanil is infused for the maintenance of anesthesia during surgery and discontinued 15 min before end of surgery
Thyroidectomy
The aim of this study is evaluation of effect of dexmedetomidine on emergence response and postoperative outcome after thyroidectomy
Vital signs
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.
Cough reflex
During recovery from anesthesia at operation room, cough reflex is measured and rated. \[Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking)\]
Ramsay Sedation Scale
When the patient has fully awaken and transferred to the recovery room, Ramsay Sedation Scale is measured.
1. Awake Patient anxious and agitated or restless or both!
2. Patient cooperative, oriented and tranquil!
3. Patient responds to commands only!
4. Asleep A brisk response to a light glabellar tap or loud auditory stimulus!
5. A sluggish response to a light glabellar tap or loud auditory stimulus!
6. No response to a light glabellar tap or loud auditory stimulus
Extubation time and Recovery time
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.
Visual analogue scale
The severity of pain after surgery is measured by VAS (at recovery room, POD 1, POD 2, and POD 3)
Postoperative bleeding
The amount of postoperative bleeding which is collected in the barovac is measured.
Postoperative complications
Postoperative complications after thyroidectomy such as hoarseness and hematoma, and reoperation due to such complication is observed.
Time to remove drainage and duration of hospital staying
The time from the end of surgery to remove drainage is measured. And the duration of hospital staying is measured.
Normal saline
Normal saline has started infusion for 15 min (as same rate of dexmedetomidine) before end of surgery as control intervention
Interventions
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Desflurane
Anesthesia is maintained with desflurane
Remifentanil
Remifentanil is infused for the maintenance of anesthesia during surgery and discontinued 15 min before end of surgery
Thyroidectomy
The aim of this study is evaluation of effect of dexmedetomidine on emergence response and postoperative outcome after thyroidectomy
Vital signs
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.
Cough reflex
During recovery from anesthesia at operation room, cough reflex is measured and rated. \[Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking)\]
Ramsay Sedation Scale
When the patient has fully awaken and transferred to the recovery room, Ramsay Sedation Scale is measured.
1. Awake Patient anxious and agitated or restless or both!
2. Patient cooperative, oriented and tranquil!
3. Patient responds to commands only!
4. Asleep A brisk response to a light glabellar tap or loud auditory stimulus!
5. A sluggish response to a light glabellar tap or loud auditory stimulus!
6. No response to a light glabellar tap or loud auditory stimulus
Extubation time and Recovery time
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.
Visual analogue scale
The severity of pain after surgery is measured by VAS (at recovery room, POD 1, POD 2, and POD 3)
Postoperative bleeding
The amount of postoperative bleeding which is collected in the barovac is measured.
Postoperative complications
Postoperative complications after thyroidectomy such as hoarseness and hematoma, and reoperation due to such complication is observed.
Time to remove drainage and duration of hospital staying
The time from the end of surgery to remove drainage is measured. And the duration of hospital staying is measured.
Dexmedetomidine
Dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr) before end of surgery as experimental intervention
Normal saline
Normal saline has started infusion for 15 min (as same rate of dexmedetomidine) before end of surgery as control intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 20-60 yr,
* ASA physical status 1-2,
* Patients undergoing elective thyroidectomy under general anesthesia
Exclusion Criteria
* History of respiratory disease or chronic cough,
* Cardiovascular disease,
* Pregnant or breast-feeding woman
20 Years
60 Years
FEMALE
No
Sponsors
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Chosun University Hospital
OTHER
Responsible Party
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Ki Tae Jung
Assist Professor
Principal Investigators
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Ki Tae Jung, M.D.
Role: STUDY_CHAIR
Chosun University Hospital
Locations
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Chosun University Hospital
Gwangju, Donggu, South Korea
Countries
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References
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Patel A, Davidson M, Tran MC, Quraishi H, Schoenberg C, Sant M, Lin A, Sun X. Dexmedetomidine infusion for analgesia and prevention of emergence agitation in children with obstructive sleep apnea syndrome undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Oct;111(4):1004-10. doi: 10.1213/ANE.0b013e3181ee82fa. Epub 2010 Aug 12.
Reeve T, Thompson NW. Complications of thyroid surgery: how to avoid them, how to manage them, and observations on their possible effect on the whole patient. World J Surg. 2000 Aug;24(8):971-5. doi: 10.1007/s002680010160.
Lee B, Lee JR, Na S. Targeting smooth emergence: the effect site concentration of remifentanil for preventing cough during emergence during propofol-remifentanil anaesthesia for thyroid surgery. Br J Anaesth. 2009 Jun;102(6):775-8. doi: 10.1093/bja/aep090. Epub 2009 May 2.
Kim SH, Kim YS, Kim S, Jung KT. Dexmedetomidine decreased the post-thyroidectomy bleeding by reducing cough and emergence agitation - a randomized, double-blind, controlled study. BMC Anesthesiol. 2021 Apr 12;21(1):113. doi: 10.1186/s12871-021-01325-6.
Other Identifiers
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2014-04-004-003
Identifier Type: OTHER
Identifier Source: secondary_id
DEX_ENT
Identifier Type: -
Identifier Source: org_study_id