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NCT Number: NCT02412150

Effect of Dexmedetomidine 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).

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Key information

Conditions

Thyroid Tumor Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chosun University Hospital

Gwangju, Donggu, 501-717, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desflurane

Drug

Anesthesia is maintained with desflurane

Other names: Anesthetic gas

Remifentanil

Drug

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

Other names: Opioid

Thyroidectomy

Procedure

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

Other names: Surgery

Vital signs

Other

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

Cough reflex

Behavioral

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

Behavioral

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

Other names: RSS

Extubation time and Recovery time

Other

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

Behavioral

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

Other names: VAS

Postoperative bleeding

Other

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

Postoperative complications

Other

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

Other

The time from the end of surgery to remove drainage is measured. And the duration of hospital staying is measured.

Dexmedetomidine

Drug

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

Other names: Precedex

normal saline

Drug

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

Other names: NS

Primary outcomes

  1. 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

Secondary outcomes

  1. Ramsay Sedation scale

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

    Ramsay Sedation scale at recovery room

  2. Extubation time

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

    time to extubation from the end of surgery

  3. 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

  4. 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

  5. Pain score

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

    Pain score: NRS

  6. 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

  7. Coughing Response

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

    Coughing Response during recovery from anesthesia

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Chosun University Hospital

Other

Registry information

Official study title

Effect of Dexmedetomidine Infusion for Postoperative Outcome and Smooth Emergence After Thyroidectomy

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2015
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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