Effect of Dexmedetomidine After Thyroidectomy

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: Completed
• Conditions: Thyroid Tumor
• Intervention / Treatment: 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; Drug: Normal saline

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: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Donggu
    • Gwangju, Donggu, Korea, Republic of, 501-717
      • Chosun university hospital

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; 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; 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.; 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; 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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ramsay Sedation scale	Ramsay Sedation scale at recovery room	During the recovery time of anesthesia, an expected average of 20 min
Extubation time	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 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	Duration of hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 1 week
Pain score	Pain score: NRS	From the end of surgery to the 3rd postoperative day (an expected average of 3 days)
Incidence of postoperative complications	Hoarseness, hematoma, and reoperation	Participants will be followed for the duration of hospital stay, an expected average of 1 week
Coughing Response	Coughing Response during recovery from anesthesia	During the recovery time of anesthesia, an expected average of 20 min

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Complications of testing drug	Hypertension, hypotension, bradycardia, tachycardia, and desaturation after infusion of dexmedetomidine or normal saline	During infusion of testing drug (15 min)

Collaborators and Investigators

• Sponsor: Chosun University Hospital
• Investigators: Study Chair: Ki Tae Jung, M.D., Chosun university hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): November 21, 2020
• Study Completion (Actual): November 25, 2020

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: April 3, 2015
• First Posted (Estimate): April 9, 2015

Study Record Updates

• Last Update Posted (Actual): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Anesthetics; Remifentanil; Dexmedetomidine; Desflurane; Anesthetics, Inhalation
• Other Study ID Numbers: DEX_ENT; 2014-04-004-003 (Other Identifier: ChounUHIRB)