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

Yonsei University

Status: Completed

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

Treatments: Drug: Propofol - remifentanil group; Drug: Dexmedetomidine - remifentanil group

Study type: Interventional

Funder types: Other

Identifiers

NCT01920113

4-2012-0621

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

DR group

Experimental group

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.

Treatment:

Drug: Dexmedetomidine - remifentanil group

PR group

Active Comparator group

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).

Treatment:

Drug: Propofol - remifentanil group