search
Back to results

The Addition of Dexmedetomidine on Postoperative Sleep for Middle-aged and Elderly Patients With Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
dexmedetomidine
Sponsored by
Nanjing PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring dexmedetomidine, sleep deprivation, gastric cancer, middle-aged and elderly patient

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Elective gastric cancer operation Age ≧ 55 years ASA classification:I to III, BMI: 18-30 kg/m2 without the history of gastrointestinal surgery the normal coagulation function -

Exclusion Criteria:

the history of gastrointestinal surgery Gastrostomy and jejunostomy sleep apnea syndrome or severe osahs Severe liver and heart dysfunction Severe mental illness

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    dexmedetomidine group

    control group

    Arm Description

    sufentanil + dexmedetomidine

    sufentanil + saline

    Outcomes

    Primary Outcome Measures

    sleep time
    total sleep time during the first three days after surgery

    Secondary Outcome Measures

    pain score
    pain score measure
    daily sufentanil consumption
    daily sufentanil consumption
    functional recovery
    time to functional recovery
    length of hospital stay
    length of hospital stay
    side effects
    lethargy and mental sluggishness

    Full Information

    First Posted
    April 12, 2017
    Last Updated
    April 14, 2017
    Sponsor
    Nanjing PLA General Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03117023
    Brief Title
    The Addition of Dexmedetomidine on Postoperative Sleep for Middle-aged and Elderly Patients With Gastric Cancer
    Official Title
    The Addition of Dexmedetomidine on Postoperative Sleep for Middle-aged and Elderly Patients With Gastric Cancer: A Prospective Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 15, 2017 (Anticipated)
    Primary Completion Date
    May 15, 2017 (Anticipated)
    Study Completion Date
    June 1, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nanjing PLA General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to find out the effect of Dexmedetomidine for treatment of sleep deprivation, pain relief and postoperative recovery on middle-aged and elderly Patients with Gastric Cancer.
    Detailed Description
    Patients were randomized to receive sufentanil 0.05ug/kh/h + dexmedetomidine 0.1ug/kg/h (DEX group) or sufentanil 0.05ug/kg/h + saline (control group) for 48h. The primary outcome was the total sleep time during the first three days after surgery. The secondary outcomes included pain score, daily sufentanil consumption, time to functional recovery, length of hospital stay and side effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer
    Keywords
    dexmedetomidine, sleep deprivation, gastric cancer, middle-aged and elderly patient

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    dexmedetomidine group
    Arm Type
    Experimental
    Arm Description
    sufentanil + dexmedetomidine
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    sufentanil + saline
    Intervention Type
    Drug
    Intervention Name(s)
    dexmedetomidine
    Intervention Description
    sufentanil 0.05ug/kh/h + dexmedetomidine 0.1ug/kg/h for 48h after surgery
    Primary Outcome Measure Information:
    Title
    sleep time
    Description
    total sleep time during the first three days after surgery
    Time Frame
    during the first three days after surgery
    Secondary Outcome Measure Information:
    Title
    pain score
    Description
    pain score measure
    Time Frame
    during the first three days after surgery
    Title
    daily sufentanil consumption
    Description
    daily sufentanil consumption
    Time Frame
    during the first three days after surgery
    Title
    functional recovery
    Description
    time to functional recovery
    Time Frame
    during the first three days after surgery
    Title
    length of hospital stay
    Description
    length of hospital stay
    Time Frame
    during the first three days after surgery
    Title
    side effects
    Description
    lethargy and mental sluggishness
    Time Frame
    during the first three days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Elective gastric cancer operation Age ≧ 55 years ASA classification:I to III, BMI: 18-30 kg/m2 without the history of gastrointestinal surgery the normal coagulation function - Exclusion Criteria: the history of gastrointestinal surgery Gastrostomy and jejunostomy sleep apnea syndrome or severe osahs Severe liver and heart dysfunction Severe mental illness -

    12. IPD Sharing Statement

    Learn more about this trial

    The Addition of Dexmedetomidine on Postoperative Sleep for Middle-aged and Elderly Patients With Gastric Cancer

    We'll reach out to this number within 24 hrs