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Trial record 2 of 6 for:    "Gastric Cancer" | "Dexmedetomidine"

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

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ClinicalTrials.gov Identifier: NCT03393403
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
KMUHIRB-F(II)-20170001, Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Pain, Postoperative Drug: Dexmedetomidine Drug: 0.9% Sodium-chloride Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Actual Study Start Date : December 23, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Dexmedetomidine_iv group
Dexmedetomidine 0.5mcg/kg (diluted in normal saline) intravenously infusion for 30min
Drug: Dexmedetomidine
0.5mcg/kg intravenous(IV)continuous infusion for 30 minutes, or 0.5mcg/kg adding to local anesthetic for subcostal TAP block
Other Name: Precedex

Experimental: Dexmedetomidine_adj group
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
Drug: Dexmedetomidine
0.5mcg/kg intravenous(IV)continuous infusion for 30 minutes, or 0.5mcg/kg adding to local anesthetic for subcostal TAP block
Other Name: Precedex

Drug: 0.9% Sodium-chloride
0.125ml/kg intravenously infusion in Dexmedetomidine_adj group and control group

Active Comparator: Control group
0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min No dexmedetomidine use
Drug: 0.9% Sodium-chloride
0.125ml/kg intravenously infusion in Dexmedetomidine_adj group and control group




Primary Outcome Measures :
  1. analgesic effect - pain intensity [ Time Frame: postoperative 3 days ]
    postoperative acute pain intensity (numerical rating scale, NRS, 0-10)


Secondary Outcome Measures :
  1. sedative effect [ Time Frame: postoperative 2 hours ]
    emergence agitation in post-anesthesia care unit (Riker sedation-agitation scale, 1-7)

  2. analgesic effect - opioid consumption [ Time Frame: postoperative 3 days ]
    Fentanyl consumption(mcg) via patient-control analgesia (PCA) pump



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393403


Contacts
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Contact: Miao-Pei Su, M.D. 0088673121101 ext 7033 cavia0803@hotmail.com

Locations
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Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung, Taiwan
Contact: Miao-Pei Su, M.D.         
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Principal Investigator: Miao-Pei Su, M.D. Physician

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Responsible Party: KMUHIRB-F(II)-20170001, Physician, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT03393403     History of Changes
Other Study ID Numbers: KMUHIRB-F(II)-20170001
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by KMUHIRB-F(II)-20170001, Kaohsiung Medical University Chung-Ho Memorial Hospital:
Subcostal transversus abdominis plane block

Additional relevant MeSH terms:
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Stomach Neoplasms
Dexmedetomidine
Pain, Postoperative
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action