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

Dexmedetomidine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03788538
• Other study ID #: 20181224
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: June 1, 2020

Study information

• Verified date: January 2021
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Blood Glucose
• Dexmedetomidine

Intervention

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.

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhuan Zhang

Country where clinical trial is conducted

China, 

Outcome

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