NCT02412150

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2020

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

6.6 years

First QC Date

March 31, 2015

Last Update Submit

November 25, 2020

Conditions

Thyroid Tumor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Ramsay Sedation scale

    During the recovery time of anesthesia, an expected average of 20 min

  • Extubation time

    During the recovery time of anesthesia, an expected average of 20 min

  • Recovery time of anesthesia

    During the recovery time of anesthesia, an expected average of 20 min

  • Duration of hospital stay

    Participants will be followed for the duration of hospital stay, an expected average of 1 week

  • Pain score

    From the end of surgery to the 3rd postoperative day (an expected average of 3 days)

  • +2 more secondary outcomes

Other Outcomes (2)

  • Vital signs

    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

  • Complications of testing drug

    During infusion of testing drug (15 min)

Study Arms (2)

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.

Drug: DesfluraneDrug: RemifentanilProcedure: ThyroidectomyOther: Vital signsBehavioral: Cough reflexBehavioral: Ramsay Sedation ScaleOther: Extubation time and Recovery timeBehavioral: Visual analogue scaleOther: Postoperative bleedingOther: Postoperative complicationsOther: Time to remove drainage and duration of hospital stayingDrug: 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.

Drug: DesfluraneDrug: RemifentanilProcedure: ThyroidectomyOther: Vital signsBehavioral: Cough reflexBehavioral: Ramsay Sedation ScaleOther: Extubation time and Recovery timeBehavioral: Visual analogue scaleOther: Postoperative bleedingOther: Postoperative complicationsOther: Time to remove drainage and duration of hospital stayingDrug: Normal saline

Interventions

DesfluraneDRUG

Anesthesia is maintained with desflurane

Also known as: Anesthetic gas
Dexmedetomidine (Group D)Normal Saline (Group N)
RemifentanilDRUG

Remifentanil is infused for the maintenance of anesthesia during surgery and discontinued 15 min before end of surgery

Also known as: Opioid
Dexmedetomidine (Group D)Normal Saline (Group N)
ThyroidectomyPROCEDURE

The aim of this study is evaluation of effect of dexmedetomidine on emergence response and postoperative outcome after thyroidectomy

Also known as: Surgery
Dexmedetomidine (Group D)Normal Saline (Group N)
Vital signsOTHER

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.

Also known as: Hemodynamics
Dexmedetomidine (Group D)Normal Saline (Group N)
Cough reflexBEHAVIORAL

During recovery from anesthesia at operation room, cough reflex is measured and rated. \[Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking)\]

Dexmedetomidine (Group D)Normal Saline (Group N)
Ramsay Sedation ScaleBEHAVIORAL

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

Also known as: RSS
Dexmedetomidine (Group D)Normal Saline (Group N)
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.

Dexmedetomidine (Group D)Normal Saline (Group N)
Visual analogue scaleBEHAVIORAL

The severity of pain after surgery is measured by VAS (at recovery room, POD 1, POD 2, and POD 3)

Also known as: VAS
Dexmedetomidine (Group D)Normal Saline (Group N)
Postoperative bleedingOTHER

The amount of postoperative bleeding which is collected in the barovac is measured.

Dexmedetomidine (Group D)Normal Saline (Group N)
Postoperative complicationsOTHER

Postoperative complications after thyroidectomy such as hoarseness and hematoma, and reoperation due to such complication is observed.

Dexmedetomidine (Group D)Normal Saline (Group N)
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.

Dexmedetomidine (Group D)Normal Saline (Group N)
DexmedetomidineDRUG

Dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr) before end of surgery as experimental intervention

Also known as: Precedex
Dexmedetomidine (Group D)
Normal salineDRUG

Normal saline has started infusion for 15 min (as same rate of dexmedetomidine) before end of surgery as control intervention

Also known as: NS
Normal Saline (Group N)

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female patient,
  • Aged 20-60 yr,
  • ASA physical status 1-2,
  • Patients undergoing elective thyroidectomy under general anesthesia

You may not qualify if:

  • Sighs of difficult airway,
  • History of respiratory disease or chronic cough,
  • Cardiovascular disease,
  • Pregnant or breast-feeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chosun University Hospital

Gwangju, Donggu, 501-717, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 20705788BACKGROUND

  • 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.

    PMID: 10865043BACKGROUND

  • 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.

    PMID: 19411668RESULT

  • 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.

    PMID: 33845761DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

DesfluraneGas ScavengersRemifentanilAnalgesics, OpioidThyroidectomySurgical Procedures, OperativeHemodynamicsDexmedetomidineSaline Solution

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEquipment and SuppliesPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesEndocrine Surgical ProceduresCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaImidazolesAzolesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ki Tae Jung, M.D.

    Chosun University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Professor

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 9, 2015

Study Start

April 1, 2014

Primary Completion

November 21, 2020

Study Completion

November 25, 2020

Last Updated

November 27, 2020

Record last verified: 2020-11

Locations

KR(1)