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Clinical Trials/NCT02325882
NCT02325882
Completed
Not Applicable

The Postoperative Analgesic Effect of Combination With Dexmedetomidine in Fentanyl-based Intravenous Patient Controlled Analgesia Compared With Conventional Thoracic Epidural and Intravenous Patient Controlled Analgesia After Radical Open Gastrectomy

Yonsei University1 site in 1 country171 target enrollmentMarch 2015
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ConditionsPostoperative Pain
InterventionsFentanyl 2Fentanyl 1Dexmedetomidine
DrugsDexmedetomidineFentanyl 1Fentanyl 2

Overview

Phase
Not Applicable
Intervention
Fentanyl 2
Conditions
Postoperative Pain
Sponsor
Yonsei University
Enrollment
171
Locations
1
Primary Endpoint
Postoperative pain
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The aim of this study to test hypothesis that addition of dexmedetomidine to fentanyl based intravenous patient controlled analgesia (PCA) improves postoperative pain compared with conventional thoracic epidural and intravenous patient controlled analgesia after radical open gastrectomy.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
March 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •ASA class I-II
  • •obtaining written informed consent from the parents
  • •aged 20-65 years who were undergoing radical open gastrectomy

Exclusion Criteria

  • •abdominal surgery previously
  • •patient who refuse the patient controlled analgesia
  • •unstable angina or congestive heart failure
  • •uncontrolled hypertension (diastolic bp\>110mmHg)
  • •coagulopathy
  • •hepatic failure
  • •renal failure
  • •bradycardia on EKG (under 50 bpm)
  • •Ventricular conduction abnormality
  • •drug hyperactivity

Arms & Interventions

Conventional fentanyl-based intravenous PCA

Intervention: Fentanyl 2

Conventional fentanyl-based epidural PCA

Intervention: Fentanyl 1

dexmedetomidine to fentanyl-based intravenous PCA

Intervention: Dexmedetomidine

Outcomes

Primary Outcomes

Postoperative pain

Time Frame: 48 hours after operation

Postoperative pain measure using verbal numerical rating scales (VNRS) for 48 hrs

Study Sites (1)

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