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Comparison of the Effect of Intravenous and Perineural Dexmedetomidine in Gastric Cancer Surgery

Primary Purpose

Gastric Cancer, Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Dexmedetomidine
0.9% Sodium-chloride
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Subcostal transversus abdominis plane block

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • gastric cancer patients undergoing gastrectomy or partial gastrectomy, who receive ultrasound-guided subcostal TAP block and PCA for postoperative analgesia

Exclusion Criteria:

  • surgery involved other visceral organ (eg. combined splenectomy or partial hepatectomy), patients with histories of adverse drug reaction to dexmedetomidine, bradycardia (baseline heart rate <60 beats/min), any type of atrioventricular block in electrocardiogram (EKG), heart failure, significant renal or hepatic impairment, severe bronchopulmonary disease, any coagulant disorder, and pregnant or breast-feeding woman.

Sites / Locations

  • Kaohsiung Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Dexmedetomidine_iv group

Dexmedetomidine_adj group

Control group

Arm Description

Dexmedetomidine 0.5mcg/kg (diluted in normal saline) intravenously infusion for 30min

Dexmedetomidine 0.5mcg/kg (adding to local anesthetic) perineural single bolus for subcostal TAP block 0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min

0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min No dexmedetomidine use

Outcomes

Primary Outcome Measures

analgesic effect - pain intensity
postoperative acute pain intensity (numerical rating scale, NRS, 0-10)

Secondary Outcome Measures

sedative effect
emergence agitation in post-anesthesia care unit (Riker sedation-agitation scale, 1-7)
analgesic effect - opioid consumption
Fentanyl consumption(mcg) via patient-control analgesia (PCA) pump

Full Information

First Posted
December 27, 2017
Last Updated
January 10, 2018
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03393403
Brief Title
Comparison of the Effect of Intravenous and Perineural Dexmedetomidine in Gastric Cancer Surgery
Official Title
Comparison of the Effect of Intravenous Continuous Dexmedetomidine Infusion and Dexmedetomidine as a Local Anesthetic Adjuvant in Subcostal Transverse Abdominis Plane Block in Patients Undergoing Gastric Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 23, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Using random case assignment to investigate the analgesic and sedative effect of intravenous dexmedetomidine and dexmedetomidine as a local anesthetic adjuvant in ultrasound-guided subcostal TAP block in gastric cancer patient undergoing gastrectomy or partial gastrectomy.
Detailed Description
The process of the experiment (brief describe) The participant patients will be randomly allocated into three groups: the intravenous dexmedetomidine group (Dex_iv group), dexmedetomidine adding to local anesthetic as an adjuvant for subcostal TAP block (Dex_adj group), and Control group. All patients receive gastrectomy or partial gastrectomy in general anesthesia as standard. Thirty minutes before the end of surgery, the patients in Dex_iv group receive 0.5mcg/kg dexmedetomidine infusion for 30 minutes, while the patients in Dex_adj group and control group receive 0.125ml/kg 0.9% normal saline IV infusion for 30 minutes. All patients have ultrasound-guided TAP block single injection after the end of surgery and before the tracheal tube extubation. The block agents in Dex_adj group is 40 ml of 0.375% ropivacaine with 0.5mcg/kg dexmedetomidine, while in Dex_iv group and control group are only 40ml of 0.375% ropivacaine. The IV PCA pump will be set up before patients awaken in the post-anesthesia care unit. All patients are assessed for the signs of emergence agitation with Riker sedation-agitation scale in the post-anesthesia care unit. The numerical rating scale (NRS) for pain intensity assessment, the opioid consumption via IV PCA pump, and the patients satisfaction will be documented for postoperative 3 days for the impact evaluation of dexmedetomidine in postoperative analgesia in patients undergoing gastric cancer surgery with subcostal TAP block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Pain, Postoperative
Keywords
Subcostal transversus abdominis plane block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine_iv group
Arm Type
Experimental
Arm Description
Dexmedetomidine 0.5mcg/kg (diluted in normal saline) intravenously infusion for 30min
Arm Title
Dexmedetomidine_adj group
Arm Type
Experimental
Arm Description
Dexmedetomidine 0.5mcg/kg (adding to local anesthetic) perineural single bolus for subcostal TAP block 0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min No dexmedetomidine use
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
0.5mcg/kg intravenous(IV)continuous infusion for 30 minutes, or 0.5mcg/kg adding to local anesthetic for subcostal TAP block
Intervention Type
Drug
Intervention Name(s)
0.9% Sodium-chloride
Intervention Description
0.125ml/kg intravenously infusion in Dexmedetomidine_adj group and control group
Primary Outcome Measure Information:
Title
analgesic effect - pain intensity
Description
postoperative acute pain intensity (numerical rating scale, NRS, 0-10)
Time Frame
postoperative 3 days
Secondary Outcome Measure Information:
Title
sedative effect
Description
emergence agitation in post-anesthesia care unit (Riker sedation-agitation scale, 1-7)
Time Frame
postoperative 2 hours
Title
analgesic effect - opioid consumption
Description
Fentanyl consumption(mcg) via patient-control analgesia (PCA) pump
Time Frame
postoperative 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: gastric cancer patients undergoing gastrectomy or partial gastrectomy, who receive ultrasound-guided subcostal TAP block and PCA for postoperative analgesia Exclusion Criteria: surgery involved other visceral organ (eg. combined splenectomy or partial hepatectomy), patients with histories of adverse drug reaction to dexmedetomidine, bradycardia (baseline heart rate <60 beats/min), any type of atrioventricular block in electrocardiogram (EKG), heart failure, significant renal or hepatic impairment, severe bronchopulmonary disease, any coagulant disorder, and pregnant or breast-feeding woman.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miao-Pei Su, M.D.
Phone
0088673121101
Ext
7033
Email
cavia0803@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miao-Pei Su, M.D.
Organizational Affiliation
Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miao-Pei Su, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of the Effect of Intravenous and Perineural Dexmedetomidine in Gastric Cancer Surgery

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