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

Not Applicable

Completed

• Conditions: Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal Dissection
• Interventions: Drug: Dexmedetomidine - remifentanil group; Drug: Propofol - remifentanil group

• Registration Number: NCT01920113
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-01
• Study Completion: 2013-03
• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-08-06
• Study First Posted: 2013-08-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-07
• Last Update Posted: 2015-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DR group	Dexmedetomidine - remifentanil 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.
PR group	Propofol - remifentanil 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).

Primary Outcome Measures

Name	Time	Method
A comparison of safety during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil	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 Outcome Measures

Name	Time	Method
A comparison of efficacy during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil	right after the drugs had administered	Efficacy : 1. whether a bolus injection of 10 mg of propofol was administered or not; 2. evaluating the depth of sedation using MOAA/S scale all through the procedure; 3. whether the en bloc resection, complete resection were done or not under the sedation

Trial Locations

Locations (1)

Anesthesiology & Pain Medicine, Yonsei university college of medicine; 🇰🇷 Seoul, Korea, Republic of