NCT02510612

Brief Summary

Dexmedetomidine's Sedative Effect on Diabetic Patient

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
120

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline
Completed

Started Aug 2015

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

July 23, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

July 23, 2015

Last Update Submit

July 28, 2015

Conditions

Diabetes

Keywords

DexmedetomidineDiabeticglycometabolismsedation

Outcome Measures

Primary Outcomes (1)

  • sedation level

    Ramsay score and BIS will be recorded before medication,5 min after medication, medication ending, 5 and 10 min after medication

    from 5 minutes before medication to 10 minutes after Dexmedetomidine discontinuance，length of time frame is about 2 hours

Secondary Outcomes (7)

  • Heart rate

    participants will be followed from operation day to first postoperative day，an expected average of 2 days

  • Mean arterial pressure

    participants will be followed from operation day to first postoperative day，an expected average of 2 days

  • blood glucose measured by Biochemical test

    participants will be followed from operation day to first postoperative day，an expected average of 2 days

  • cortisol measured by Biochemical test

    participants will be followed from operation day to first postoperative day，an expected average of 2 days

  • insulin measured by Biochemical test

    participants will be followed from operation day to first postoperative day，an expected average of 2 days

  • +2 more secondary outcomes

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Patients in group D will be given dexmedetomidine during anesthesia induction and maintenance phase respectively.In induction phase infuse 1μg/Kg of dexmedetomidine in 10 minutes， the speed in maintenance phase is 0.4μg/Kg.h

Drug: Dexmedetomidine

placebo

PLACEBO COMPARATOR

Patients in group P will be given normal saline during anesthesia induction and maintenance phase

Drug: placebo

Interventions

DexmedetomidineDRUG

During anesthesia induction, all patients will be given propofol,fentanyl,vecuronium bromide.But before induction start in Dexmedetomidine(D) group, patient will be given dexmedetomidine 1μg/Kg for 10 minutes In anesthesia maintenance, D group will be given dexmedetomidine 0.4μg/Kg.h until 40 minutes before the end of surgery

Also known as: Yi Si
Dexmedetomidine
placeboDRUG

During anesthesia induction, all patients will be given propofol,fentanyl,vecuronium bromide.But before induction start in Placebo(P) group, patient will be given placebo for 10 minutes In anesthesia maintenance, D group will be given placebo until 40 minutes before the end of surgery

Also known as: normal saline
placebo

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 40 and 60
  • Selective epigastrium surgery

You may not qualify if:

  • American Society of Anesthesiology (ASA) Physical Status\>3
  • Duration of operation \>3 hours
  • Hypovolemia,sinus bradycardia,atrioventricular block,severe hepatic and renal dysfunction,severe cardiac insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

DexmedetomidineSaline Solution

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Yulong Song

CONTACT

86-13519185656

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthetist

Study Record Dates

First Submitted

July 23, 2015

First Posted

July 29, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

July 29, 2015

Record last verified: 2015-07