Effect of Dexmedetomidine After Thyroidectomy

November 25, 2020 updated by: Ki Tae Jung, Chosun University Hospital

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Donggu
      • Gwangju, Donggu, Korea, Republic of, 501-717
        • Chosun University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Desflurane
Anesthesia is maintained with desflurane
Other Names:
  • Anesthetic gas
Drug: Remifentanil
Remifentanil is infused for the maintenance of anesthesia during surgery and discontinued 15 min before end of surgery
Other Names:
  • Opioid
Procedure: Thyroidectomy
The aim of this study is evaluation of effect of dexmedetomidine on emergence response and postoperative outcome after thyroidectomy
Other Names:
  • Surgery
Other: 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.

Other Names:
  • Hemodynamics
Behavioral: 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)]
Behavioral: 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
Other Names:
  • RSS
Other: 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.

Behavioral: Visual analogue scale
The severity of pain after surgery is measured by VAS (at recovery room, POD 1, POD 2, and POD 3)
Other Names:
  • VAS
Other: Postoperative bleeding
The amount of postoperative bleeding which is collected in the barovac is measured.
Other: Postoperative complications
Postoperative complications after thyroidectomy such as hoarseness and hematoma, and reoperation due to such complication is observed.
Other: 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.
Drug: Dexmedetomidine
Dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr) before end of surgery as experimental intervention
Other Names:
  • Precedex
Placebo Comparator: 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.
Drug: Desflurane
Anesthesia is maintained with desflurane
Other Names:
  • Anesthetic gas
Drug: Remifentanil
Remifentanil is infused for the maintenance of anesthesia during surgery and discontinued 15 min before end of surgery
Other Names:
  • Opioid
Procedure: Thyroidectomy
The aim of this study is evaluation of effect of dexmedetomidine on emergence response and postoperative outcome after thyroidectomy
Other Names:
  • Surgery
Other: 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.

Other Names:
  • Hemodynamics
Behavioral: 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)]
Behavioral: 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
Other Names:
  • RSS
Other: 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.

Behavioral: Visual analogue scale
The severity of pain after surgery is measured by VAS (at recovery room, POD 1, POD 2, and POD 3)
Other Names:
  • VAS
Other: Postoperative bleeding
The amount of postoperative bleeding which is collected in the barovac is measured.
Other: Postoperative complications
Postoperative complications after thyroidectomy such as hoarseness and hematoma, and reoperation due to such complication is observed.
Other: 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.
Drug: Normal saline
Normal saline has started infusion for 15 min (as same rate of dexmedetomidine) before end of surgery as control intervention
Other Names:
  • NS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From the end of surgery to the 3rd postoperative day (an expected average of 3 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ramsay Sedation scale
Time Frame: During the recovery time of anesthesia, an expected average of 20 min
Ramsay Sedation scale at recovery room
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
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 Frame: During the recovery time of anesthesia, an expected average of 20 min
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
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Duration of hospital stay
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)
Pain score: NRS
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
Hoarseness, hematoma, and reoperation
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
Coughing Response during recovery from anesthesia
During the recovery time of anesthesia, an expected average of 20 min

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vital signs
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
Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate
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
Time Frame: During infusion of testing drug (15 min)
Hypertension, hypotension, bradycardia, tachycardia, and desaturation after infusion of dexmedetomidine or normal saline
During infusion of testing drug (15 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chosun University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ki Tae Jung, M.D., Chosun University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DEX_ENT
  • 2014-04-004-003 (Other Identifier: ChounUHIRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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