Thyroid Tumor
Conditions
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.
Interventions
DRUGDesflurane
Anesthesia is maintained with desflurane
DRUGRemifentanil
Remifentanil is infused for the maintenance of anesthesia during surgery and discontinued 15 min before end of surgery
PROCEDUREThyroidectomy
The aim of this study is evaluation of effect of dexmedetomidine on emergence response and postoperative outcome after thyroidectomy
OTHERVital 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.
BEHAVIORALCough reflex
During recovery from anesthesia at operation room, cough reflex is measured and rated. \[Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking)\]
BEHAVIORALRamsay 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
OTHERExtubation 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.
BEHAVIORALVisual analogue scale
The severity of pain after surgery is measured by VAS (at recovery room, POD 1, POD 2, and POD 3)
OTHERPostoperative bleeding
The amount of postoperative bleeding which is collected in the barovac is measured.
OTHERPostoperative complications
Postoperative complications after thyroidectomy such as hoarseness and hematoma, and reoperation due to such complication is observed.
OTHERTime 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.
DRUGDexmedetomidine
Dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr) before end of surgery as experimental intervention
DRUGNormal saline
Normal saline has started infusion for 15 min (as same rate of dexmedetomidine) before end of surgery as control intervention
Sponsors
Chosun University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative bleeding | From the end of surgery to the 3rd postoperative day (an expected average of 3 days) | Postoperative bleeding: Sum of bleeding via barovac |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ramsay Sedation scale | During the recovery time of anesthesia, an expected average of 20 min | Ramsay Sedation scale at recovery room |
| Extubation time | During the recovery time of anesthesia, an expected average of 20 min | time to extubation from the end of surgery |
| Recovery time of anesthesia | During the recovery time of anesthesia, an expected average of 20 min | time to transfer to recovery room from the end of surgery |
| Duration of hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 1 week | Duration of hospital stay |
| Incidence of postoperative complications | Participants will be followed for the duration of hospital stay, an expected average of 1 week | Hoarseness, hematoma, and reoperation |
| Coughing Response | During the recovery time of anesthesia, an expected average of 20 min | Coughing Response during recovery from anesthesia |
| Pain score | From the end of surgery to the 3rd postoperative day (an expected average of 3 days) | Pain score: NRS |
Other
| Measure | Time frame | Description |
|---|---|---|
| Vital signs | 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 |
| Complications of testing drug | During infusion of testing drug (15 min) | Hypertension, hypotension, bradycardia, tachycardia, and desaturation after infusion of dexmedetomidine or normal saline |
Countries
South Korea
Outcome results
None listed