Dexmedetomidine Affect Diabetic Patient's Glucose Metabolism (dadpgm)

July 28, 2015 updated by: Song yulong, Shaanxi Provincial People's Hospital

Perioperative Dexmedetomidine Affect Diabetic Patient's Glucose Metabolism

Dexmedetomidine's Sedative Effect on Diabetic Patient

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Dexmedetomidine is a high selective α2 agonist,its sedative and analgesia feature is acclaimed. The pathogenesis of type 2 diabetes mellitus is associated with α2 excessive adrenaline receptors expression. This study is to evaluate whether the use of dexmedetomidine is helpful to Diabetic Patient through its antisympathetic effect

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 40 and 60
  • Selective epigastrium surgery
  • In

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine
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
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
Other Names:
  • Yi Si
Placebo Comparator: placebo
Patients in group P will be given normal saline during anesthesia induction and maintenance phase
Drug: placebo
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
Other Names:
  • normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sedation level
Time Frame: from 5 minutes before medication to 10 minutes after Dexmedetomidine discontinuance，length of time frame is about 2 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: participants will be followed from operation day to first postoperative day，an expected average of 2 days
recorded at before medication,5 min after medication, medication ending, 5 and 10 min after medication, before intubation, after intubation, after skin incision,60 minutes after skin incision, after extubation,first day after operation
participants will be followed from operation day to first postoperative day，an expected average of 2 days
Mean arterial pressure
Time Frame: participants will be followed from operation day to first postoperative day，an expected average of 2 days
10 min after medication, before intubation, after intubation, after skin incision,60 minutes after skin incision, after extubation,first day after operation
participants will be followed from operation day to first postoperative day，an expected average of 2 days
blood glucose measured by Biochemical test
Time Frame: participants will be followed from operation day to first postoperative day，an expected average of 2 days
it will be recorded immediately after the entrance to the operating room, before operation, 60 minutes after incision, after extubation, first day after operation
participants will be followed from operation day to first postoperative day，an expected average of 2 days
cortisol measured by Biochemical test
Time Frame: participants will be followed from operation day to first postoperative day，an expected average of 2 days
it will be recorded immediately after the entrance to the operating room, before operation, 60 minutes after incision, after extubation, first day after operation
participants will be followed from operation day to first postoperative day，an expected average of 2 days
insulin measured by Biochemical test
Time Frame: participants will be followed from operation day to first postoperative day，an expected average of 2 days
it will be recorded immediately after the entrance to the operating room, before operation, 60 minutes after incision, after extubation, first day after operation
participants will be followed from operation day to first postoperative day，an expected average of 2 days
adrenaline measured by Biochemical test
Time Frame: participants will be followed from operation day to first postoperative day，an expected average of 2 days
it will be recorded immediately after the entrance to the operating room, before operation, 60 minutes after incision, after extubation, first day after operation
participants will be followed from operation day to first postoperative day，an expected average of 2 days
noradrenaline measured by Biochemical test
Time Frame: participants will be followed from operation day to first postoperative day，an expected average of 2 days
it will be recorded immediately after the entrance to the operating room, before operation, 60 minutes after incision, after extubation, first day after operation
participants will be followed from operation day to first postoperative day，an expected average of 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaanxi Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 28, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150618

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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