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Efficacy of Dexmedetomidine for Cough Suppression in Patients Undergoing Thyroid Surgery (EDCSTS)

Primary Purpose

Anesthesia Complication

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine Hydrochloride
Normal Saline
Dexmedetomidine Hydrochloride
Dexmedetomidine Hydrochloride
Sponsored by
Min Su
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia Complication focused on measuring dexmedetomidine, coughing during anesthetic emergence, thyroid surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 30Kg/m2 ≥ BMI > 18Kg/m2;
  2. undergoing general anesthesia;
  3. ASA physical status I and II
  4. undergoing elective thyroid surgery.

Exclusion Criteria:

  1. hyperthyroidism;
  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

Sites / Locations

  • China,Chongqing The First Affiliated Hospital of Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine low dose group

Dexmedetomidine median dose group

Dexmedetomidine high dose group

Control group (normal saline group)

Arm Description

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

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

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

Patients in this group are received saline iv infusion of 5mL·h-1 from incision to 20-30 minutes before the end of surgery

Outcomes

Primary Outcome Measures

Incidence of coughing during anesthetic emergence
incidence of coughing within 10 minutes after extubation

Secondary Outcome Measures

Ccoughing on a four-point scale during anesthetic emergence
Evaluate the severity of coughing within 10 minutes after extubation by a four-point scale
Ramsay score during anesthetic emergence
Ramsay score 1min, 5min, 10min, and 30min after extubation
Bruggrmann comfort scale score
Bruggrmann comfort scale score 30min and 24 hrs after extubation
VAS pain score
VAS pain score 30min, 24 hrs and 48 hrs after extubation
Respiratory rate (RR)
Respiratory rate 1min, 5min, 10min, and 30min after extubation
Heart rate
Heart rate 1min, 5min, 10min, and 30min after extubation
mean arterial pressure
Mean arterial pressure 1min, 5min, 10min, and 30min after extubation

Full Information

First Posted
September 4, 2017
Last Updated
October 12, 2017
Sponsor
Min Su
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1. Study Identification

Unique Protocol Identification Number
NCT03312413
Brief Title
Efficacy of Dexmedetomidine for Cough Suppression in Patients Undergoing Thyroid Surgery
Acronym
EDCSTS
Official Title
Efficacy of Dexmedetomidine for Cough Suppression During Anesthetic Emergence in Patients Undergoing Thyroid Surgery: A Randomized, Double Blinded, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Min Su

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Maintenance of a remifentanil infusion during anesthetic emergence has been reported to decrease the incidence of coughing and thereby help to ensure a smooth emergence. It may, however, cause respiratory depression and possibly delay emergence. The purpose of this study was to investigate the effect of different dose of dexmedetomidine infusion on cough suppression during emergence from general anesthesia in patients undergoing thyroid surgery. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia Complication
Keywords
dexmedetomidine, coughing during anesthetic emergence, thyroid surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine low dose group
Arm Type
Experimental
Arm Description
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
Arm Title
Dexmedetomidine median dose group
Arm Type
Experimental
Arm Description
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
Arm Title
Dexmedetomidine high dose group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group (normal saline group)
Arm Type
Placebo Comparator
Arm Description
Patients in this group are received saline iv infusion of 5mL·h-1 from incision to 20-30 minutes before the end of surgery
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Hydrochloride
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Hydrochloride
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Hydrochloride
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of coughing during anesthetic emergence
Description
incidence of coughing within 10 minutes after extubation
Time Frame
within 10 minutes after endotracheal extubation
Secondary Outcome Measure Information:
Title
Ccoughing on a four-point scale during anesthetic emergence
Description
Evaluate the severity of coughing within 10 minutes after extubation by a four-point scale
Time Frame
within 10 minutes after endotracheal extubation
Title
Ramsay score during anesthetic emergence
Description
Ramsay score 1min, 5min, 10min, and 30min after extubation
Time Frame
within 30 minutes after endotracheal extubation
Title
Bruggrmann comfort scale score
Description
Bruggrmann comfort scale score 30min and 24 hrs after extubation
Time Frame
within 24 hrs after endotracheal extubation
Title
VAS pain score
Description
VAS pain score 30min, 24 hrs and 48 hrs after extubation
Time Frame
within 48 hrs after endotracheal extubation
Title
Respiratory rate (RR)
Description
Respiratory rate 1min, 5min, 10min, and 30min after extubation
Time Frame
within 30min after endotracheal extubation
Title
Heart rate
Description
Heart rate 1min, 5min, 10min, and 30min after extubation
Time Frame
within 30 minutes after endotracheal extubation
Title
mean arterial pressure
Description
Mean arterial pressure 1min, 5min, 10min, and 30min after extubation
Time Frame
within 30 minutes after endotracheal extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 30Kg/m2 ≥ BMI > 18Kg/m2; undergoing general anesthesia; ASA physical status I and II undergoing elective thyroid surgery. Exclusion Criteria: hyperthyroidism; preoperative bradycardia; liver function impairment; renal function impairment; heart function failure; history of asthma or COPD; history of diabetes; cognition function impairment; pregnant or lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SU Min, M.D.
Phone
86-23-89011068
Email
ms89011068@163.com
Facility Information:
Facility Name
China,Chongqing The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su Min, MD
Phone
+86-23-89011068
Email
ms89011068@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Dexmedetomidine for Cough Suppression in Patients Undergoing Thyroid Surgery

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