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The Effect of Dexmedetomidine for Emergence Cough

Primary Purpose

Cough

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
Remifentanil
Normal saline
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cough focused on measuring dexmedetomidine, remifentanil, extubation

Eligibility Criteria

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

Inclusion Criteria:

  • ASA physical status I or II undergoing endoscopic sinus surgery or septoplasty under general anesthesia

Exclusion Criteria:

  • predicted difficult airway
  • body mass index > 35 kg/m2,
  • recent upper respiratory infection
  • asthma
  • current smoker
  • patients using angiotensin converting enzyme-inhibitors
  • uncontrolled hypertension

Sites / Locations

  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexmedetomidine

Remifentanil

Arm Description

Dexmedetomidine was infused before end of surgery and remifentanil was maintained at predetermined effect-site concentration during the emergence period

Normal saline was infused before end of surgery and remifentanil was maintained at predetermined effect-site concentration during the emergence period

Outcomes

Primary Outcome Measures

Number of cough
Number of cough or a strong and sudden contraction of the abdomen during periextubation periextubation periods

Secondary Outcome Measures

Full Information

First Posted
August 6, 2018
Last Updated
January 6, 2020
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03622502
Brief Title
The Effect of Dexmedetomidine for Emergence Cough
Official Title
The Effect of Dexmedetomidine on the Remifentanil Concentration for Preventing Cough During Emergence After Propofol Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 16, 2018 (Actual)
Primary Completion Date
March 22, 2019 (Actual)
Study Completion Date
March 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dexmedetomidine or remifentanil are effective in attenuating cough during peri-extubation period after general anesthesia. The purpose of this study was to investigate the effect of dexmedetomidine on the remifentanil concentration for the cough suppression during anesthetic emergence.
Detailed Description
Administration of dexmedetomidine before end of surgery could reduce airway reflexes and hemodynamic changes during tracheal extubation. Compared with remifentanil alone, administration of dexmedetomidine in combination with remifentanil is effective in relieving cough and hemodynamic changes without inhibition of respiration. The purpose of this study was to investigate the effect of dexmedetomidine on the remifentanil concentration for the cough suppression during anesthetic emergence using the modified up-and-down method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
Keywords
dexmedetomidine, remifentanil, extubation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Dexmedetomidine was infused before end of surgery and remifentanil was maintained at predetermined effect-site concentration during the emergence period
Arm Title
Remifentanil
Arm Type
Active Comparator
Arm Description
Normal saline was infused before end of surgery and remifentanil was maintained at predetermined effect-site concentration during the emergence period
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Prededex
Intervention Description
Dexmedetomidine 0.5mcg/kg was infused over 10 min before end of the surgery
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 2.0 ng/ml)
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
0.9% NaCl
Intervention Description
Normal saline was infused over 10 min before end of the surgery
Primary Outcome Measure Information:
Title
Number of cough
Description
Number of cough or a strong and sudden contraction of the abdomen during periextubation periextubation periods
Time Frame
from end of surgery to 5 min after tracheal extubation]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status I or II undergoing endoscopic sinus surgery or septoplasty under general anesthesia Exclusion Criteria: predicted difficult airway body mass index > 35 kg/m2, recent upper respiratory infection asthma current smoker patients using angiotensin converting enzyme-inhibitors uncontrolled hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Yeop Kim
Organizational Affiliation
Ajou University Hospital, Suwon, Gyeongki-do, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeongki-do
ZIP/Postal Code
443-721
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33941098
Citation
Kim HY, Kwak HJ, Lee D, Lee JH, Min SK, Kim JY. Comparison of remifentanil concentrations with and without dexmedetomidine for the prevention of emergence cough after nasal surgery: a randomized double-blinded trial. BMC Anesthesiol. 2021 May 4;21(1):136. doi: 10.1186/s12871-021-01358-x.
Results Reference
derived

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The Effect of Dexmedetomidine for Emergence Cough

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