Efficacy of Dexmedetomidine for Cough Suppression in Patients Undergoing Thyroid Surgery
NCT ID: NCT03312413
Last Updated: 2017-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2017-08-10
2018-12-31
Brief Summary
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American Society of Anesthesiologists physical status I-II adults undergoing elective thyroidectomy under general anesthesia are recruited and randomly allocated to receive dexmedetomidine iv infusion of 0.2μg·kg-1·h-1 (Group D1, n = 100), 0.5μg·kg-1·h-1 (Group D2, n = 100), 0.7μg·kg-1·h-1 (Group D3, n = 100) or saline (Group C, n = 100). Primary outcome is the incidence of coughing during emergence. Second outcomes include severity of coughing, which is assessed using a four-point scale; Ramsay score, Bruggrmann comfort scale score, VAS pain score are recorded. The respiratory rate (RR), heart rate (HR), and mean arterial pressure are also recorded.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dexmedetomidine low dose group
Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.2μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery
Dexmedetomidine Hydrochloride
Dexmedetomidine Hydrochloride 0.2 μg·kg-1·h-will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
Dexmedetomidine median dose group
Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.5μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery
Dexmedetomidine Hydrochloride
Dexmedetomidine Hydrochloride 0.5 μg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
Dexmedetomidine high dose group
Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.7μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery
Dexmedetomidine Hydrochloride
Dexmedetomidine Hydrochloride 0.7 μg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
Control group (normal saline group)
Patients in this group are received saline iv infusion of 5mL·h-1 from incision to 20-30 minutes before the end of surgery
Normal Saline
Normal saline 0.5 mL·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
Interventions
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Dexmedetomidine Hydrochloride
Dexmedetomidine Hydrochloride 0.2 μg·kg-1·h-will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
Normal Saline
Normal saline 0.5 mL·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
Dexmedetomidine Hydrochloride
Dexmedetomidine Hydrochloride 0.5 μg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
Dexmedetomidine Hydrochloride
Dexmedetomidine Hydrochloride 0.7 μg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
Eligibility Criteria
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Inclusion Criteria
2. undergoing general anesthesia;
3. ASA physical status I and II
4. undergoing elective thyroid surgery.
Exclusion Criteria
2. preoperative bradycardia;
3. liver function impairment;
4. renal function impairment;
5. heart function failure;
6. history of asthma or COPD;
7. history of diabetes;
8. cognition function impairment;
9. pregnant or lactating women
18 Years
65 Years
ALL
No
Sponsors
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Min Su
OTHER
Responsible Party
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Min Su
clinical professor
Locations
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China,Chongqing The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Su Min, MD
Role: primary
Other Identifiers
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CYYY2017
Identifier Type: -
Identifier Source: org_study_id