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Effects of Dexmedetomidine on Modulation of Perioperative Blood Glucose

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788538
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Zhuan Zhang, Yangzhou University

Brief Summary:
The investigators aimed to explore effects of dexmedetomidine on modulation of perioperative blood glucose and relevant hormone during the general anesthesia with surgery time ≥ 4 hours, and the effects on postoperative complications. Eighty participants (American Society of Anesthesiologists grades I or II, of both sexes,aged 18-65 yr,with BMI of 18.5-27 kg/m2) scheduled for elective surgery under general anesthesia with surgery time ≥ 4 hours were enrolled in this study. The participants were divided into four groups: control group (group C),0.25 μg/kg/h group (group 1), 0.5 μg/kg/h group (group 2), 1 μg/kg/h group (group 3).10 minutes before anesthesia induction, all participants were administrated with dexmedetomidine 1 μg/kg/min.At the beginning of induction, dexmedetomidine was changed to corresponding maintenance dose in each group. Blood samples were taken at the beginning of dexmedetomidine (T0), the beginning of skin incision (T1), 1 h after skin incision (T2), 2 h after skin incision (T3), the end of the surgery (T4) and 24 h after operation (T5) for the value of blood glucose and relevant hormone. Also, investigators also record the total amount of propofol and sufentanil at the end of surgery,and the complications within 24 h after the surgery.

Condition or disease Intervention/treatment Phase
Dexmedetomidine Blood Glucose Drug: dexmedetomidine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Dexmedetomidine on Modulation of Perioperative Blood Glucose
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
No Intervention: group 1 with no dexmedetomidine
Experimental: group 2 with dexmedetomidine 0.25μg/kg/h Drug: dexmedetomidine
10 minutes before anesthesia induction, all patients were administrated with dexmedetomidine 1 μg/kg/min.At the beginning of induction, dexmedetomidine was changed to corresponding maintenance dose in each group.

Experimental: group 2 with dexmedetomidine 0.5μg/kg/h Drug: dexmedetomidine
10 minutes before anesthesia induction, all patients were administrated with dexmedetomidine 1 μg/kg/min.At the beginning of induction, dexmedetomidine was changed to corresponding maintenance dose in each group.

Experimental: group 3 with dexmedetomidine 1μg/kg/h Drug: dexmedetomidine
10 minutes before anesthesia induction, all patients were administrated with dexmedetomidine 1 μg/kg/min.At the beginning of induction, dexmedetomidine was changed to corresponding maintenance dose in each group.




Primary Outcome Measures :
  1. Effects of dexmedetomidine on perioperative blood glucose [ Time Frame: Intraoperative ]
    The changes of blood glucose during the surgery period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing operations over 4 h under general anesthesia

Exclusion Criteria:

  • the patients with bradycardia, hypoglycemia, heart disease, adrenal tumor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788538


Contacts
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Contact: zhang zhuan, MD +86 15062791355 zhangzhuancg@163.com

Locations
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China, Jiangsu
the Affiliated Hospital of Yangzhou University, Yangzhou University Recruiting
Yangzhou, Jiangsu, China, 225012
Contact: Xinnong Liu, Dr.    +8615062791355    zhangzhuanjy@163.com   
Sponsors and Collaborators
Zhuan Zhang

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Responsible Party: Zhuan Zhang, Clinical Professor, Yangzhou University
ClinicalTrials.gov Identifier: NCT03788538    
Other Study ID Numbers: 20181224
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action