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

• ClinicalTrials.gov Identifier: NCT03788538
• Recruitment Status: Completed
• First Posted: December 27, 2018
• Last Update Posted: February 3, 2021
• Sponsor: Zhuan Zhang
• Information provided by (Responsible Party): Zhuan Zhang, Yangzhou University

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: November 1, 2017
• Actual Primary Completion Date: June 1, 2020
• Actual Study Completion Date: June 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.

Outcome Measures

Primary Outcome Measures :

1. Effects of dexmedetomidine on perioperative blood glucose (mmol/L) [ Time Frame: 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
2. Effects of dexmedetomidine on perioperative insulin (μIU/ml) [ Time Frame: 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
3. Effects of dexmedetomidine on perioperative glucagon and catecholamine (pg/ml) [ Time Frame: 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
4. Effects of dexmedetomidine on perioperative cortisol (ng/ml) [ Time Frame: 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

• Ages Eligible for Study: 40 Years to 80 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,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

China, Jiangsu

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China, 225012

Sponsors and Collaborators

Zhuan Zhang

More Information

• Responsible Party: Zhuan Zhang, Clinical Professor, Yangzhou University
• ClinicalTrials.gov Identifier: NCT03788538
• Other Study ID Numbers: 20181224
• First Posted: December 27, 2018
• Last Update Posted: February 3, 2021
• Last Verified: January 2021

• 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:

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