Effect of Dexmedetomidine After Thyroidectomy
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
Drug: Remifentanil
Remifentanil is infused for the maintenance of anesthesia during surgery and discontinued 15 min before end of surgery
Other Names:
Procedure: Thyroidectomy
The aim of this study is evaluation of effect of dexmedetomidine on emergence response and postoperative outcome after thyroidectomy
Other Names:
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:
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:
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:
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:
|
| 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:
Drug: Remifentanil
Remifentanil is infused for the maintenance of anesthesia during surgery and discontinued 15 min before end of surgery
Other Names:
Procedure: Thyroidectomy
The aim of this study is evaluation of effect of dexmedetomidine on emergence response and postoperative outcome after thyroidectomy
Other Names:
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:
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:
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:
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:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- Pain score [From the end of surgery to the 3rd postoperative day (an expected average of 3 days)]
Pain score: NRS
- 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
Other Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female patient,
-
Aged 20-60 yr,
-
ASA physical status 1-2,
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chosun University Hospital | Gwangju | Donggu | Korea, Republic of | 501-717 |
Sponsors and Collaborators
- Chosun University Hospital
Investigators
- Study Chair: Ki Tae Jung, M.D., Chosun University Hospital
Study Documents (Full-Text)
None provided.More Information
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. Review.
- DEX_ENT
- 2014-04-004-003