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临床试验/NCT05136157
NCT05136157已完成早期 1 期

Intravenous Bolus-infusion Versus Sliding Scale of Insulin for Intra-operative Glycemic Control in Elective Laparotomy Surgeries

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
60
试验地点
1
主要终点
intra-operative CBG level between 140- 180 mg/dl all over the operation

研究概览

简要总结

Pre-operative blood glucose (BG) concentrations in type 2 diabetic patients undergoing elective non-cardiac surgery; have an increased incidence of in-hospital morbidity for cardiopulmonary and infectious complications. Also, hyperglycemia is associated with increased production and impaired scavenging of oxygen reactive species, polymorph nuclear neutrophil dysfunction and decreased intracellular killing, resulting in poor wound healing and increased risk of infection. Thus, perioperative optimal glucose management contributes to reduced morbidity and mortality. Recommendations favor moderate levels of capillary blood glucose (CBG); maintaining it in the range of 140-180 mg/dl.

Peri-operative doses of rapidly acting insulin for glycemic control could be done by the sliding scale or the bolus-infusion approaches. The sliding scale of insulin is commonly used to manage peri-operative hyper-glycaemia. It involves administering prescribed doses of insulin when the CBG is within determined ranges and withholding insulin when the CBG is within normal range. When used as a sole therapy; it results in under-insulinisation and thus hyper-glycaemia. The use of a dynamic insulin regimen like the intravenous bolus-infusion approach; allows adjusting the blood glucose level according to the insulin sensitivity of each patient, thus, better glucose control and less variations than the intermittent intravenous bolus of short-acting insulin in the sliding scale despite the same blood glucose target.

详细描述

compare the rapidly acting insulin injection via the bolus-infusion approach (Study group) to the sliding scale approach (Control group) as regards the intra-operative glycemic control

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status II patients
  • aged 21-65 years
  • known to have type1 or 2 diabetes mellitusw
  • pre-operative fasting blood glucose level ˂ 350 mg/dl
  • scheduled to undergo elective laparotomy surgeries
  • expected to exceed 2 hours duration under general anesthesia

排除标准

  • Patients' refusal
  • diabetic ketoacidosis
  • hyperglycemic hyperosmolar syndrome
  • serum potassium ˂3.5 mEq/L
  • HbA1c >8.5%.

研究组 & 干预措施

Study group

Active Comparator

Bolus-Infusion approach of rapidly acting crystalline insulin. The patient intra-operative blood glucose will be divided by 100. The resultant rapidly acting crystalline insulin units will be given intravenously over 10 minutes, and then continued as an intra-venous infusion per hour. The Capillary Blood Glucose (CBG) will be measured every 30 minutes and in the PACU with readjustment of the bolus-infusion dose as required

干预措施: Rapid-Acting Insulin (Drug)

Control group

Active Comparator

The sliding scale approach of rapidly acting crystalline insulin will be used according to the intra-operative blood glucose; 4 IU of insulin will be given when the CBG 180-250 mg/dl, 6 IU of insulin will be given when the CBG 251-300 mg/dl, 8 IU of insulin will be given when the CBG 301-350 mg/dl and 10 IU of insulin will be given when the CBG 351-400 mg/dl (5). The CBG will be measured every 30 minutes and in the PACU.

干预措施: Rapid-Acting Insulin (Drug)

结局指标

主要结局

intra-operative CBG level between 140- 180 mg/dl all over the operation

时间窗: 7 months

Base line CBG will be measured for all patients then every 30 minutes and in the PACU

次要结局

  • Total IU of rapidly acting insulin given to the patient(7 months)
  • Peri-operative changes in serum potassium(7 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghada M.Samir

Assistant Professor of Anesthesia, Intensive care and Pain Management

Ain Shams University

研究点 (1)

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