Thyroid TumorNCT02412150
Effect of Dexmedetomidine After Thyroidectomy
A study testing Desflurane, Remifentanil and Thyroidectomy in people with Thyroid Tumor, run by Chosun University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Thyroid Tumor
- What is being tested?
- Desflurane, Remifentanil and Thyroidectomy
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to 25 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patient,
- Aged 20-60 yr,
- ASA physical status 1-2,
- Patients undergoing elective thyroidectomy under general anesthesia
Who cannot join
- Sighs of difficult airway,
- History of respiratory disease or chronic cough,
- Cardiovascular disease,
- Pregnant or breast-feeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dexmedetomidine Infusion for Postoperative Outcome and Smooth Emergence After Thyroidectomy
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).
Read the 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.
- Conditions
- Thyroid Tumor
- Being tested
- Desflurane, Remifentanil, Thyroidectomy, Vital signs, Cough reflex
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Also called Anesthetic gas
Anesthesia is maintained with desflurane
RemifentanilDrug
Also called Opioid
Remifentanil is infused for the maintenance of anesthesia during surgery and discontinued 15 min before end of surgery
ThyroidectomyProcedure or surgery
Also called Surgery
The aim of this study is evaluation of effect of dexmedetomidine on emergence response and postoperative outcome after thyroidectomy
Vital signsOther
Also called Hemodynamics
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 reflexBehavioural
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 ScaleBehavioural
Also called RSS
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
Extubation time and Recovery timeOther
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 scaleBehavioural
Also called VAS
The severity of pain after surgery is measured by VAS (at recovery room, POD 1, POD 2, and POD 3)
Postoperative bleedingOther
The amount of postoperative bleeding which is collected in the barovac is measured.
Postoperative complicationsOther
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 stayingOther
The time from the end of surgery to remove drainage is measured. And the duration of hospital staying is measured.
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr) before end of surgery as experimental intervention
Normal salineDrug
Also called NS
Normal saline has started infusion for 15 min (as same rate of dexmedetomidine) before end of surgery as control intervention
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine (Group D) | Experimental | 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. Receives: 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 |
| Normal Saline (Group N) | Placebo comparator | 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. Receives: 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: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative bleeding
Postoperative bleeding: Sum of bleeding via barovac
Measured: From the end of surgery to the 3rd postoperative day (an expected average of 3 days)
Secondary outcomes (7)
Ramsay Sedation scale
Ramsay Sedation scale at recovery room
Measured: During the recovery time of anesthesia, an expected average of 20 min
Extubation time
time to extubation from the end of surgery
Measured: 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
Measured: During the recovery time of anesthesia, an expected average of 20 min
Duration of hospital stay
Duration of hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Pain score
Pain score: NRS
Measured: From the end of surgery to the 3rd postoperative day (an expected average of 3 days)
Incidence of postoperative complications
Hoarseness, hematoma, and reoperation
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Coughing Response
Coughing Response during recovery from anesthesia
Measured: During the recovery time of anesthesia, an expected average of 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startApr 2014
- Primary completion21 Nov 2020
- Study completion25 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thyroid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chosun University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Tae Jung, Chosun University Hospital
- Investigators
- Ki Tae Jung, M.D., Study chair, Chosun University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412150
- Sponsor's protocol ID
- DEX_ENT
- Other IDs
- 2014-04-004-003
- Status last verified
- Nov 2020
- First submitted
- 31 Mar 2015
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20705788Reeve 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.
PubMed 10865043Lee 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.
PubMed 19411668Kim 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.
PubMed 33845761
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine Infusion for Postoperative Outcome and Smooth Emergence After Thyroidectomy
- ClinicalTrials.gov ID
- NCT02412150
- Acronym / sponsor ID
- DEX_ENT
- Conditions
- Thyroid Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Chosun University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 21 Nov 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine (Group D) | Experimental | 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: DexmedetomidineAfter 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. |
| Normal Saline (Group N) | Placebo comparator | 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: Normal salineAfter 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patient,
- Aged 20-60 yr,
- ASA physical status 1-2,
- Patients undergoing elective thyroidectomy under general anesthesia
Key exclusion criteria (4 listed)
- Sighs of difficult airway,
- History of respiratory disease or chronic cough,
- Cardiovascular disease,
- Pregnant or breast-feeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesfluraneAlso: Anesthetic gasAnesthesia is maintained with desflurane | Drug | Dexmedetomidine (Group D), Normal Saline (Group N) |
| RemifentanilAlso: OpioidRemifentanil is infused for the maintenance of anesthesia during surgery and discontinued 15 min before end of surgery | Drug | Dexmedetomidine (Group D), Normal Saline (Group N) |
| ThyroidectomyAlso: SurgeryThe aim of this study is evaluation of effect of dexmedetomidine on emergence response and postoperative outcome after thyroidectomy | Procedure or surgery | Dexmedetomidine (Group D), Normal Saline (Group N) |
| Vital signsAlso: HemodynamicsSystolic 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. | Other | Dexmedetomidine (Group D), Normal Saline (Group N) |
| Cough reflexDuring 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)] | Behavioural | Dexmedetomidine (Group D), Normal Saline (Group N) |
| Ramsay Sedation ScaleAlso: RSSWhen 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 | Behavioural | Dexmedetomidine (Group D), Normal Saline (Group N) |
| Extubation time and Recovery timeThe 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. | Other | Dexmedetomidine (Group D), Normal Saline (Group N) |
| Visual analogue scaleAlso: VASThe severity of pain after surgery is measured by VAS (at recovery room, POD 1, POD 2, and POD 3) | Behavioural | Dexmedetomidine (Group D), Normal Saline (Group N) |
| Postoperative bleedingThe amount of postoperative bleeding which is collected in the barovac is measured. | Other | Dexmedetomidine (Group D), Normal Saline (Group N) |
| Postoperative complicationsPostoperative complications after thyroidectomy such as hoarseness and hematoma, and reoperation due to such complication is observed. | Other | Dexmedetomidine (Group D), Normal Saline (Group N) |
| Time to remove drainage and duration of hospital stayingThe time from the end of surgery to remove drainage is measured. And the duration of hospital staying is measured. | Other | Dexmedetomidine (Group D), Normal Saline (Group N) |
| DexmedetomidineAlso: PrecedexDexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr) before end of surgery as experimental intervention | Drug | Dexmedetomidine (Group D) |
| Normal salineAlso: NSNormal saline has started infusion for 15 min (as same rate of dexmedetomidine) before end of surgery as control intervention | Drug | Normal Saline (Group N) |
Primary outcome
Postoperative bleeding
Time frame: From the end of surgery to the 3rd postoperative day (an expected average of 3 days)
Postoperative bleeding: Sum of bleeding via barovac
7 secondary outcomes
Ramsay Sedation scale
Time frame: During the recovery time of anesthesia, an expected average of 20 min
Extubation time
Time frame: During the recovery time of anesthesia, an expected average of 20 min
Recovery time of anesthesia
Time frame: During the recovery time of anesthesia, an expected average of 20 min
Duration of hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Pain score
Time frame: From the end of surgery to the 3rd postoperative day (an expected average of 3 days)
Incidence of postoperative complications
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Coughing Response
Time frame: During the recovery time of anesthesia, an expected average of 20 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Background: PubMed 20705788Patel 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.
- Background: PubMed 10865043Reeve 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 publication: PubMed 19411668Lee 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.
- Derived from this study: PubMed 33845761Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki Tae Jung, M.D. study chair
Chosun University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desflurane, Remifentanil and Thyroidectomy in people with Thyroid Tumor, run by Chosun University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative bleeding (time frame: From the end of surgery to the 3rd postoperative day (an expected average of 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02412150, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.