A Comparison of Efficacy and Safety During Endoscopic Submucosal Dissection Between Dexmedetomidine-remifentanil and Propofol-remifentanil
Overview
- Phase
- N/A
- Intervention
- Dexmedetomidine - remifentanil group
- Conditions
- Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal Dissection
- Sponsor
- Yonsei University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- A comparison of safety during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
DR group
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.
Intervention: Dexmedetomidine - remifentanil group
PR group
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: Propofol - remifentanil group
Outcomes
Primary Outcomes
A comparison of safety during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
Time Frame: right after the drugs had administered
Safety : whether the complications as follows occur or not 1. systolic blood pressure under 90mmHg or 20% out of range of the baseline SBP 2. heart rate under 50bpm 3. oxygen saturation under 90%, respiratory rate under 7 per minute
Secondary Outcomes
- A comparison of efficacy during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil(right after the drugs had administered)