Effect of Dexmedetomidine After Thyroidectomy

Thyroid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02412150
• Other study ID #: DEX_ENT
• Secondary ID: 2014-04-004-003
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: November 25, 2020

Study information

• Verified date: November 2020
• Source: Chosun University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (postoperative bleeding and hospital staying).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: November 25, 2020
• Est. primary completion date: November 21, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Neoplasms
• Thyroid Tumor

Intervention

Drug:
• Desflurane
Anesthesia is maintained with desflurane
• Remifentanil
Remifentanil is infused for the maintenance of anesthesia during surgery and discontinued 15 min before end of surgery

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

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.

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)]
• Ramsay Sedation Scale
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:
• 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:
• Postoperative bleeding
The amount of postoperative bleeding which is collected in the barovac is measured.
• Postoperative complications
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
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
• Normal saline
Normal saline has started infusion for 15 min (as same rate of dexmedetomidine) before end of surgery as control intervention

Locations

Country	Name	City	State
Korea, Republic of	Chosun University Hospital	Gwangju	Donggu

Sponsors (1)

Lead Sponsor	Collaborator
Chosun University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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 — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vital signs	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
Other	Complications of testing drug	Hypertension, hypotension, bradycardia, tachycardia, and desaturation after infusion of dexmedetomidine or normal saline	During infusion of testing drug (15 min)
Primary	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	Ramsay Sedation scale	Ramsay Sedation scale at recovery room	During the recovery time of anesthesia, an expected average of 20 min
Secondary	Extubation time	time to extubation from the end of surgery	During the recovery time of anesthesia, an expected average of 20 min
Secondary	Recovery time of anesthesia	time to transfer to recovery room from the end of surgery	During the recovery time of anesthesia, an expected average of 20 min
Secondary	Duration of hospital stay	Duration of hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary	Pain score	Pain score: NRS	From the end of surgery to the 3rd postoperative day (an expected average of 3 days)
Secondary	Incidence of postoperative complications	Hoarseness, hematoma, and reoperation	Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary	Coughing Response	Coughing Response during recovery from anesthesia	During the recovery time of anesthesia, an expected average of 20 min