Back to resultsA Comparison of Efficacy and Safety During Endoscopic Submucosal Dissection Between Dexmedetomidine-remifentanil and Propofol-remifentanil
Primary Purpose
Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal Dissection
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine - remifentanil group
Propofol - remifentanil group
Sponsored by
About this trial
This is an interventional treatment trial for Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal Dissection focused on measuring Endoscopic submucosal dissection, propofol, remifentanil, dexmedetomidine, efficacy, safeness
Eligibility Criteria
Inclusion Criteria:
- Age ≥20
- American Society of Anaesthesiologists(ASA) physical status classification I~III
- Early gastric cancer patients who were scheduled for Endoscopic submucosal dissection
Exclusion Criteria:
- Age < 20
- American Society of Anaesthesiologists(ASA) physical status classification IV
- those with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
- known drug allergies or history of drug abuse
- psychological disease
Sites / Locations
- Anesthesiology & Pain Medicine, Yonsei university college of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DR group
PR group
Arm Description
In Group DR, a bolus dose of 0.5mcg/kg dexmedetomidine was injected intravenously 5 minutes before the start of the procedure (Precedex®, Abbott, Istanbul, Turkey). And a continuous infusion dose of 0.3-0.7mcg/hr/kg was started.
In Group PR, a bolus injection of 1 mg/kg of propofol was followed by a continuous infusion at a rate of 3-5mg/hr/kg(Pofol®, Dongkook Pharm. Co. Ltd., Seoul, Korea) using an infusion pump (Syringe Pump TE-331, Terumo Japan).
Outcomes
Primary Outcome Measures
A comparison of safety during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
Safety : whether the complications as follows occur or not
systolic blood pressure under 90mmHg or 20% out of range of the baseline SBP
heart rate under 50bpm
oxygen saturation under 90%, respiratory rate under 7 per minute
Secondary Outcome Measures
A comparison of efficacy during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
Efficacy :
whether a bolus injection of 10 mg of propofol was administered or not
evaluating the depth of sedation using MOAA/S scale all through the procedure
whether the en bloc resection, complete resection were done or not under the sedation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01920113
Brief Title
A Comparison of Efficacy and Safety During Endoscopic Submucosal Dissection Between Dexmedetomidine-remifentanil and Propofol-remifentanil
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Adequate, safe sedation is essential for Endoscopic submucosal dissection. Dexmedetomidine is a potent and selective a2-adrenoceptor agonist used for sedative and analgesic effects, but it is limited to use alone. The investigators designed this study to compare the effect and safety of two sedatives, dexmedetomidine and propofol in Endoscopic Submucosal Dissection (ESD), when sufficient analgesia-remifentanil is administered all throughout the procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal Dissection
Keywords
Endoscopic submucosal dissection, propofol, remifentanil, dexmedetomidine, efficacy, safeness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DR group
Arm Type
Experimental
Arm Description
In Group DR, a bolus dose of 0.5mcg/kg dexmedetomidine was injected intravenously 5 minutes before the start of the procedure (Precedex®, Abbott, Istanbul, Turkey). And a continuous infusion dose of 0.3-0.7mcg/hr/kg was started.
Arm Title
PR group
Arm Type
Active Comparator
Arm Description
In Group PR, a bolus injection of 1 mg/kg of propofol was followed by a continuous infusion at a rate of 3-5mg/hr/kg(Pofol®, Dongkook Pharm. Co. Ltd., Seoul, Korea) using an infusion pump (Syringe Pump TE-331, Terumo Japan).
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine - remifentanil group
Intervention Type
Drug
Intervention Name(s)
Propofol - remifentanil group
Primary Outcome Measure Information:
Title
A comparison of safety during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
Description
Safety : whether the complications as follows occur or not
systolic blood pressure under 90mmHg or 20% out of range of the baseline SBP
heart rate under 50bpm
oxygen saturation under 90%, respiratory rate under 7 per minute
Time Frame
right after the drugs had administered
Secondary Outcome Measure Information:
Title
A comparison of efficacy during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
Description
Efficacy :
whether a bolus injection of 10 mg of propofol was administered or not
evaluating the depth of sedation using MOAA/S scale all through the procedure
whether the en bloc resection, complete resection were done or not under the sedation
Time Frame
right after the drugs had administered
Other Pre-specified Outcome Measures:
Title
A comparison of patient's satisfaction during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
Description
Patients' satisfaction : investigate in four steps questionaire (very good, good, bearable and unbearable) when the patients' were discharged from PACU
Time Frame
within 24hrs after procedure
Title
A comparison of gastric motility, easiness for procedure, operator's satisfaction during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
Description
Subjects' motility grading during procedure, easiness of procedure, operator's satisfaction : investigate in four steps questionaires by the operator after the procedure
Time Frame
right after the drugs had administered
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥20
American Society of Anaesthesiologists(ASA) physical status classification I~III
Early gastric cancer patients who were scheduled for Endoscopic submucosal dissection
Exclusion Criteria:
Age < 20
American Society of Anaesthesiologists(ASA) physical status classification IV
those with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
known drug allergies or history of drug abuse
psychological disease
Facility Information:
Facility Name
Anesthesiology & Pain Medicine, Yonsei university college of medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
25834336
Citation
Kim N, Yoo YC, Lee SK, Kim H, Ju HM, Min KT. Comparison of the efficacy and safety of sedation between dexmedetomidine-remifentanil and propofol-remifentanil during endoscopic submucosal dissection. World J Gastroenterol. 2015 Mar 28;21(12):3671-8. doi: 10.3748/wjg.v21.i12.3671.
Results Reference
derived
Learn more about this trial
A Comparison of Efficacy and Safety During Endoscopic Submucosal Dissection Between Dexmedetomidine-remifentanil and Propofol-remifentanil
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