Clinical trial NCT02412150: Effect of Dexmedetomidine After Thyroidectomy
Official title: Effect of Dexmedetomidine Infusion for Postoperative Outcome and Smooth Emergence After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Tumor
Lead sponsor: Chosun University Hospital
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 139
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative bleeding
timeFrame: From the end of surgery to the 3rd postoperative day (an expected average of 3 days)
Secondary outcomes:
measure: Ramsay Sedation scale
timeFrame: During the recovery time of anesthesia, an expected average of 20 min
measure: Extubation time
timeFrame: During the recovery time of anesthesia, an expected average of 20 min
measure: Recovery time of anesthesia
timeFrame: During the recovery time of anesthesia, an expected average of 20 min
measure: Duration of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Pain score
timeFrame: From the end of surgery to the 3rd postoperative day (an expected average of 3 days)
measure: Incidence of postoperative complications
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Coughing Response
timeFrame: During the recovery time of anesthesia, an expected average of 20 min
Other outcomes:
measure: Vital signs
timeFrame: 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
measure: Complications of testing drug
timeFrame: During infusion of testing drug (15 min)
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
state: Donggu
Study officials:
affiliation: Chosun University Hospital
name: Ki Tae Jung, M.D.
role: STUDY_CHAIR
References:
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.
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. doi: 10.1007/s002680010160.
citation: 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.
citation: 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.