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

NCT03788538 | Completed

• 1 other identifier: 20181224
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexmedetomidine; Blood Glucose

Outcome Measures

Primary Outcomes (4)

• 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..

• 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.

• 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.

• 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.

Study Arms (3)

group 1 with no dexmedetomidine

NO INTERVENTION

group 2 with dexmedetomidine 0.25μg/kg/h

EXPERIMENTAL

Drug: dexmedetomidine

group 2 with dexmedetomidine 0.5μg/kg/h

EXPERIMENTAL

Drug: dexmedetomidine

Interventions

dexmedetomidine DRUG

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.

group 2 with dexmedetomidine 0.25μg/kg/h; group 2 with dexmedetomidine 0.5μg/kg/h

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zhuan Zhang: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, 225012, China

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 25, 2018
• First Posted: December 27, 2018
• Study Start: November 1, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-01

Locations

CN (1)