Effects of Dexmedetomidine on Modulation of Perioperative Blood Glucose and Related Hormones

Sponsor

Zhuan Zhang (Other)

Overall Status

Completed

CT.gov ID

NCT03788538

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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. 75 participants (American Society of Anesthesiologists grades I or II, of both sexes,aged 40-80 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: group C (control saline group, no dexmedetomidine use), group D1 (dexmedetomidine loading dose 1 mcg/kg, maintenance dose 0.25 mcg/kg/h), group D2 (dexmedetomidine loading dose 1 mcg/kg, maintenance dose 0.5 mcg/kg/h).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), the end of the surgery (T3) and 1 h after patient transfer to PACU (T4) for the value of blood glucose,lactate and relevant hormones. 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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Effects of Dexmedetomidine on Modulation of Perioperative Blood Glucose and Related Hormones

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Jun 1, 2020

Actual Study Completion Date :

Jun 1, 2020

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Effects of dexmedetomidine on perioperative blood glucose (mmol/L) [before dexmedetomidine infusion, 1 hour after incision, at the end of surgery, 1 hour after patient transfer to postanesthesia care unit..]
The changes of blood glucose during the surgery period
Effects of dexmedetomidine on perioperative insulin (μIU/ml) [before dexmedetomidine infusion, 1 hour after incision, at the end of surgery, 1 hour after patient transfer to postanesthesia care unit.]
The changes of insulin during the surgery period
Effects of dexmedetomidine on perioperative glucagon and catecholamine (pg/ml) [before dexmedetomidine infusion, 1 hour after incision, at the end of surgery, 1 hour after patient transfer to postanesthesia care unit.]
The changes of glucagon and catecholamine during the surgery period
Effects of dexmedetomidine on perioperative cortisol (ng/ml) [before dexmedetomidine infusion, 1 hour after incision, at the end of surgery, 1 hour after patient transfer to postanesthesia care unit.]
The changes of cortisol during the surgery period

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients undergoing operations over 4 h under general anesthesia,ASA physical status I or II, irrespective of showing gender bias, aged between 50-75 years old, and having a body mass index (BMI) between 18.5-28 kg/m2.

Exclusion Criteria:

the patients with bradycardia, hypoglycemia, heart disease, adrenal tumor,diabetes or showed ≥7.0 mmol/L, or HbA1c level ≥6.5%.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu	China	225012

Sponsors and Collaborators

Zhuan Zhang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhuan Zhang, Clinical Professor, Yangzhou University

ClinicalTrials.gov Identifier:

NCT03788538

Other Study ID Numbers:

20181224

First Posted:

Dec 27, 2018

Last Update Posted:

Feb 3, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Dexmedetomidine

Study Results

No Results Posted as of Feb 3, 2021