Back to resultsThe 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
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
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
NCT ID
NCT03117023
First Posted
April 12, 2017
Last Updated
April 14, 2017
Sponsor
Nanjing PLA General Hospital
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
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