A Comparison of Efficacy and Safety During Endoscopic Submucosal Dissection Between Dexmedetomidine-remifentanil and Propofol-remifentanil

Study Overview
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Brief Summary
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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.

Conditions
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Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal Dissection

Intervention / Treatment
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* Drug: Dexmedetomidine - remifentanil group
* Drug: Propofol - remifentanil group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DR group<br>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. | Drug: Dexmedetomidine - remifentanil group<br> <br> |
| Active Comparator: PR group<br>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). | Drug: Propofol - remifentanil group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | right after the drugs had administered | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | right after the drugs had administered | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic submucosal dissection, propofol, remifentanil, dexmedetomidine, efficacy, safeness