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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2019/06/25
    • Registered Date : 2019/07/12
    • Last Updated Date : 2019/07/10
Background Information
1.Background  
CRIS Registration Number KCT0004136 
Unique Protocol ID SCHCA 2018-06-041-002 
Public/Brief Title Dosing study of esmolol for reducing hemodynamic changes during lightwand intubation 
Scientific Title Dosing study of esmolol for reducing hemodynamic changes during lightwand intubation  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered at Other Registry No
Healthcare Benefit
Approval Status
Not applicable
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number SCHCA 2018-06-041-002 
Approval Date 2018-08-20 
Institutional Review Board  
- Name Soonchunhyang university hospital IRB  
- Address 44, Suncheonhyang 4-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea 
- Telephone 041-570-2721 
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Jinku Kang 
- Title Dr 
- Telephone +82-2-364-5689 
- Affiliation Soon Chun Hyang University Hospital Cheonan 
- Address 44, Suncheonhyang 4-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea 
Contact Person for Public Queries
- Name Jinku Kang 
- Title Dr 
- Telephone +82-2-364-5689 
- Affiliation Soon Chun Hyang University Hospital Cheonan 
- Address 44, Suncheonhyang 4-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea 
Contact Person for Updating Information
- Name Jinku Kang 
- Title Dr 
- Telephone +82-2-364-5689 
- Affiliation Soon Chun Hyang University Hospital Cheonan 
- Address 44, Suncheonhyang 4-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea 
Status
4. Status Status  
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2018-09-03 , Actual
Target Number of Participant 140
Primary Completion Date 2019-02-04 , Actual
Study Completion Date 2019-02-11 , Actual
Recruitment Status by Participating Study Site 1 
- Name of Study Site Soon Chun Hyang University Hospital Cheonan 
- Recruitment Status Completed  
- Date of First Enrollment 2018-09-03 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Soon Chun Hyang University Hospital Cheonan 
- Organization Type Medical Institute  
- Project ID 2018-06-041-002 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Soon Chun Hyang University Hospital Cheonan 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
Lay Summary Intubation is an inevitable procedure during general anesthesia. However, the traditionally used direct laryngoscope involves lifting the epiglottis and endotracheal tube, passing by the vocal cords, and exerting a strong stimulation to the trachea. This results in an elevated level of catecholamine and consequent increases in blood pressure and heart rate, exerting a negative influence on the patients’ cardiovascular system. Lightwand is a tool that can be utilized in patients with poor teeth conditions or difficulties in mouth opening due to temporomandibular joint problems. This tool allows for intubation without lifting the glottis using light wave. Esmolol is a relatively cardiac-selective beta blocker with an extremely short onset and half-life. Several studies have assessed the volume of esmolol required to minimize hemodynamic changes, in case of intubation through direct laryngoscope. On the other hand, for lightwand-based intubation, which is known to result in similar hemodynamic changes, only a few studies have indicated an attempt to identify the appropriate volume of esmolol. Thus, the authors of this study aimed to identify the appropriate volume of esmolol that will minimize hemodynamic changes during intubation using a lightwand.  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Supportive Care
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Double 
Blinded Subject Subject, Investigator 
Allocation RCT 
Intervention Type Drug  
Intervention Description Esmolol. For the ‘C’ group, 20 mL of normal saline was prepared, while the ‘E0.5’, ‘E1’, and ‘E2’ groups had 20 mL of normal saline containing esmolol 0.5 mg/kg, 1 mg/kg, and 2 mg/kg, respectively.  
Number of Arms
Arm 1 Arm Label C group 
Target Number of Participant 35 
Arm Type Placebo comparator 
Arm Description Normal saline 20mL IV blous injection 
Arm 2 Arm Label E0.5 group 
Target Number of Participant 35 
Arm Type Experimental 
Arm Description Esmolol, 0.5mg/kg IV blous injection 
Arm 3 Arm Label E1 group 
Target Number of Participant 35 
Arm Type Experimental 
Arm Description Esmolol, 1mg/kg IV blous injection 
Arm 4 Arm Label E2 group 
Target Number of Participant 35 
Arm Type Experimental 
Arm Description Esmolol, 2mg/kg IV blous injection 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Not Applicable
American Society of Anesthesiologists (ASA) class I & II who required general anesthesia for elective surgery, aged 20-59 yesrs  
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 20 Year ~ 60 Year
Description American Society of Anesthesiologists (ASA) class I & II who required general anesthesia for elective surgery  
Exclusion Criteria Intubation time exceeding 15 seconds, and patients with hypertension, cardiac problems, cervical spine fracture, tumors, or polyps in the upper airway, those with expected airway difficulties, and patients currently using beta blockers were excluded from the study.  
Healthy Volunteers  
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
- Outcome mean arterial blood pressure 
- Timepoint Before induction(Baseline), 2 minutes before intubation, 1 minute after intubation, 3 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation 
Primary Outcome(s) 2 
- Outcome heart rate 
- Timepoint Before induction(Baseline), 2 minutes before intubation, 1 minute after intubation, 3 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation 
Secondary Outcome(s) 1 
- Outcome rate-pressure product 
- Timepoint Before induction(Baseline), 2 minutes before intubation, 1 minute after intubation, 3 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Undecided