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

NCT ID: NCT01920113

Last Updated: 2015-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-03-31

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.

Detailed Description

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Conditions

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Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal Dissection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Dexmedetomidine - remifentanil group

Intervention Type DRUG

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).

Group Type ACTIVE_COMPARATOR

Propofol - remifentanil group

Intervention Type DRUG

Interventions

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Dexmedetomidine - remifentanil group

Intervention Type DRUG

Propofol - remifentanil group

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Anesthesiology & Pain Medicine, Yonsei university college of medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 25834336 (View on PubMed)

Other Identifiers

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4-2012-0621

Identifier Type: -

Identifier Source: org_study_id

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