NCT03117023

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3 gastric-cancer

Timeline
Completed

Started Apr 2017

Shorter than P25 for phase_3 gastric-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

April 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 17, 2017

Status Verified

April 1, 2017

Enrollment Period

1 month

First QC Date

April 12, 2017

Last Update Submit

April 14, 2017

Conditions

Gastric Cancer

Keywords

dexmedetomidinesleep deprivationgastric cancermiddle-aged and elderly patient

Outcome Measures

Primary Outcomes (1)

  • sleep time

    total sleep time during the first three days after surgery

    during the first three days after surgery

Secondary Outcomes (5)

  • pain score

    during the first three days after surgery

  • daily sufentanil consumption

    during the first three days after surgery

  • functional recovery

    during the first three days after surgery

  • length of hospital stay

    during the first three days after surgery

  • side effects

    during the first three days after surgery

Study Arms (2)

dexmedetomidine group

EXPERIMENTAL

sufentanil + dexmedetomidine

Drug: dexmedetomidine

control group

NO INTERVENTION

sufentanil + saline

Interventions

dexmedetomidineDRUG

sufentanil 0.05ug/kh/h + dexmedetomidine 0.1ug/kg/h for 48h after surgery

dexmedetomidine group

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach NeoplasmsSleep Deprivation

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 17, 2017

Study Start

April 15, 2017

Primary Completion

May 15, 2017

Study Completion

June 1, 2017

Last Updated

April 17, 2017

Record last verified: 2017-04