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NCT Number: NCT03788538

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

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.

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Key information

Conditions

Dexmedetomidine Blood Glucose

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, 225012, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Zhuan Zhang

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 27, 2018
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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