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Effect of Dexmedetomidine After Thyroidectomy

Primary Purpose

Thyroid Tumor

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Desflurane
Remifentanil
Thyroidectomy
Vital signs
Cough reflex
Ramsay Sedation Scale
Extubation time and Recovery time
Visual analogue scale
Postoperative bleeding
Postoperative complications
Time to remove drainage and duration of hospital staying
Dexmedetomidine
Normal saline
Sponsored by
Chosun University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thyroid Tumor

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chosun University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine (Group D)

Normal Saline (Group N)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postoperative bleeding
Postoperative bleeding: Sum of bleeding via barovac

Secondary Outcome Measures

Ramsay Sedation scale
Ramsay Sedation scale at recovery room
Extubation time
time to extubation from the end of surgery
Recovery time of anesthesia
time to transfer to recovery room from the end of surgery
Duration of hospital stay
Duration of hospital stay
Pain score
Pain score: NRS
Incidence of postoperative complications
Hoarseness, hematoma, and reoperation
Coughing Response
Coughing Response during recovery from anesthesia

Full Information

First Posted
March 31, 2015
Last Updated
November 25, 2020
Sponsor
Chosun University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02412150
Brief Title
Effect of Dexmedetomidine After Thyroidectomy
Official Title
Effect of Dexmedetomidine Infusion for Postoperative Outcome and Smooth Emergence After Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 21, 2020 (Actual)
Study Completion Date
November 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chosun University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Tumor

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine (Group D)
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal Saline (Group N)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Desflurane
Other Intervention Name(s)
Anesthetic gas
Intervention Description
Anesthesia is maintained with desflurane
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Opioid
Intervention Description
Remifentanil is infused for the maintenance of anesthesia during surgery and discontinued 15 min before end of surgery
Intervention Type
Procedure
Intervention Name(s)
Thyroidectomy
Other Intervention Name(s)
Surgery
Intervention Description
The aim of this study is evaluation of effect of dexmedetomidine on emergence response and postoperative outcome after thyroidectomy
Intervention Type
Other
Intervention Name(s)
Vital signs
Other Intervention Name(s)
Hemodynamics
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cough reflex
Intervention Description
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)]
Intervention Type
Behavioral
Intervention Name(s)
Ramsay Sedation Scale
Other Intervention Name(s)
RSS
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Extubation time and Recovery time
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Visual analogue scale
Other Intervention Name(s)
VAS
Intervention Description
The severity of pain after surgery is measured by VAS (at recovery room, POD 1, POD 2, and POD 3)
Intervention Type
Other
Intervention Name(s)
Postoperative bleeding
Intervention Description
The amount of postoperative bleeding which is collected in the barovac is measured.
Intervention Type
Other
Intervention Name(s)
Postoperative complications
Intervention Description
Postoperative complications after thyroidectomy such as hoarseness and hematoma, and reoperation due to such complication is observed.
Intervention Type
Other
Intervention Name(s)
Time to remove drainage and duration of hospital staying
Intervention Description
The time from the end of surgery to remove drainage is measured. And the duration of hospital staying is measured.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr) before end of surgery as experimental intervention
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
NS
Intervention Description
Normal saline has started infusion for 15 min (as same rate of dexmedetomidine) before end of surgery as control intervention
Primary Outcome Measure Information:
Title
Postoperative bleeding
Description
Postoperative bleeding: Sum of bleeding via barovac
Time Frame
From the end of surgery to the 3rd postoperative day (an expected average of 3 days)
Secondary Outcome Measure Information:
Title
Ramsay Sedation scale
Description
Ramsay Sedation scale at recovery room
Time Frame
During the recovery time of anesthesia, an expected average of 20 min
Title
Extubation time
Description
time to extubation from the end of surgery
Time Frame
During the recovery time of anesthesia, an expected average of 20 min
Title
Recovery time of anesthesia
Description
time to transfer to recovery room from the end of surgery
Time Frame
During the recovery time of anesthesia, an expected average of 20 min
Title
Duration of hospital stay
Description
Duration of hospital stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
Pain score
Description
Pain score: NRS
Time Frame
From the end of surgery to the 3rd postoperative day (an expected average of 3 days)
Title
Incidence of postoperative complications
Description
Hoarseness, hematoma, and reoperation
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
Coughing Response
Description
Coughing Response during recovery from anesthesia
Time Frame
During the recovery time of anesthesia, an expected average of 20 min
Other Pre-specified Outcome Measures:
Title
Vital signs
Description
Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate
Time Frame
From 15 min before the end of surgery to the time when the patient has transferred to the recovery room, an expected average of 40 min
Title
Complications of testing drug
Description
Hypertension, hypotension, bradycardia, tachycardia, and desaturation after infusion of dexmedetomidine or normal saline
Time Frame
During infusion of testing drug (15 min)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Tae Jung, M.D.
Organizational Affiliation
Chosun University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chosun University Hospital
City
Gwangju
State/Province
Donggu
ZIP/Postal Code
501-717
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
20705788
Citation
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.
Results Reference
background
PubMed Identifier
10865043
Citation
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.
Results Reference
background
PubMed Identifier
19411668
Citation
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.
Results Reference
result
PubMed Identifier
33845761
Citation
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.
Results Reference
derived

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Effect of Dexmedetomidine After Thyroidectomy

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