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临床试验/NCT05040412
NCT05040412已完成不适用

Comparison of the Patients With Diabetes Mellitus Using Either Insulin or Oral Antidiabetic Drug In Terms Of Difficult Laryngoscopy

Bagcilar Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2020年1月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
192
试验地点
1
主要终点
Intubation time

研究概览

简要总结

Diabetes Mellitus is known to be a risk factor for difficult laryngoscopy. Several studies showed that diabetes mellitus is responsible for 30% of difficult laryngoscopy.Insulin and oral antidiabetic drugs are two main current medication prescribed for diabetes patients.Insulin is responsible for muscle hypertrophy and weigh gain.Oral antidiabetic drugs induces muscle atrophy. The aim of this study is to evaluate the differences in the difficult laryngoscopy as a general anesthetic component in patients with Diabetes Mellitus (DM) using either insulin or oral antidiabetic drug (OAD).

详细描述

DM is accepted as a risk factor for difficult intubation.OAD and insulin are two main pharmacological treatment component of DM.Insulin induces respiratory smooth muscle contraction.Otherwise, OAD drugs ca affect muscle atrophy in patients with type II DM patients.The use of these drugs may affect laryngoscopy during endotracheal intubation,which is a component of general anesthesia.Metformin causes muscle atrophy and weight loss.Some in vitro studies have shown an induction of cell apoptosis with therapeutic doses of sulfonylureas which can lead to atrophy.Glinides can cause atrophy in experimental animals.Hypoglycemia and weight gain are two important side effects of intensive insulin therapy.İnsulin is the major anabolic hormone in the body. Insulin binds to receptors on adipose tissues and potentiate inhibition of lypolysis and storage of triglycerids.And this cause obesity.This is one of the reasons that suggest the relationship between insulin and difficult airway.The effect of insulin on airway smooth muscle leads to increased airway contraction,cell proliferation,and the thicker,stiffer and more hypercontractile airway.In some studies,type II DM patients with duration of more than 5 years switched to insulin therapy and airway hypersensitivity was observed in the first three months.Insulin plays an anabolic role in skeletal muscle by enhancing amino acids transport in skeletal muscle and by increasing the rate of protein synthesis.İnsulin induces air way smooth muscle contraction through the production of contractile prostaglandins, which in turn are dependent on Rho-kinase for their contractile effects.Prostaglandins also stimulate IL-6 and MuRF-1 transcription in human skeletal muscles.Prostaglandin regulates skeletal muscle mass and function.Therefore,insulin may cause airway skeletal muscle contraction and may be the reason of difficult laryngoscopy.

The aim of this study is to evaluate the differences in the difficult laryngoscopy as a general anesthetic component in patients with Diabetes Mellitus (DM) using either insulin or oral antidiabetic drug (OAD).

METHODS After the approval of the local ethics committee of our hospital, a study was planned for a total of 230 patients including Type I and Type II DM patients and non-DM patients as a control group who would undergo elective surgery between 25.01.2020-30.04.2020.Age, gender, body mass index (BMI), Mallampati scores, thyromental distance (TMD), sternomental distance (SMD), inter-incisor distance (ID) and neck extension measurements were taken.Preoperative HbA1C levels, DM type, diagnosis time and duration of insulin or OAD use were recorded.Patients without DM, patients using insulin and patients using OAD were grouped as group C, group I and group D, respectively.DM patients were planned to be operated as first patient in the morning.50 mg of ranitidine,10 mg of metoclopramide and 1 gr of cefazolin for surgical prophylaxis were administered intravenously 30 minutes before anthesia induction.Patients were preoxygenated with 100% O2 for 3 minutes.As diabetes mellitus patients are under high risk of aspiration due to gastroparesis,we applied rapid sequence induction technique.1 mcg/kg fentanyl citrate,2 mg/kg propofol,1mg/kg rocuronium bromide were given intravenously according to patient's adjusted body weight.After low tidal volume ventilation with face mask,the trachea was intubated by using DL (Macintosh laryngoscope).During intubation, the following data were documented:Cormack-Lehane grade, number of laryngoscopic attempts, intubation time, intubation success at the first attempt, performance of backward-upward-rightward pressure (BURP) maneuver and requirement of use of different airway equipments were compared between the groups. Adverse events related to tracheal intubation were evaluated: desaturation (SPO2<94), hypercabia (ETCO2>35), hypertension (mean arterial pressure >20% above baseline values), tachycardia (heart rate >20% above baseline values), new onset arrhythmia, laryngospasm, bronchospasm, airway trauma and sore throat in PACU). The primary outcome measures are mallampati score,thyromental distance,Cormack-Lehane grade and the time to intubation,secondary outcome measures are first-attempt intubation success,number of laryngoscopic attempts,performance of backward-upward-rightward pressure (BURP) maneuver and requirement of use of different airway equipments.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients undergoing elective surgery
  • •Patients needing endotracheal intubation
  • •Patients having eithe Type I or Type II diabetes mellitus (those who have been using insulin or OAD for at least the past 5 years)

排除标准

  • •Emergency surgery
  • •Difficult intubation story
  • •İmpaired airway anatomy
  • •Morbidly obese (BMI > 40 kg/m2)

研究组 & 干预措施

Diabetic mellitus patients using insulin

Experimental

The trachea will be intubated by direct laryngoscopy.

干预措施: difficult laryngoscopy (Device)

Diabetic patients using oral antidiabetic drug

Experimental

The trachea will be intubated by direct laryngoscopy.

干预措施: difficult laryngoscopy (Device)

结局指标

主要结局

Intubation time

时间窗: 0-120 seconds after intubation.The time elapsed between the passage of the larygoscope through the teeth and the detection of ETCO2

Mallampati class,Thyromental distance,Cormack Lehane classification,Intubation time

次要结局

  • Intubation difficulty(-120 seconds after intubation.The time elapsed between the passage of the larygoscope through the teeth and the detection of ETCO2)

研究者

发起方
Bagcilar Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Kerem Erkalp

Professor

Bagcilar Training and Research Hospital

研究点 (1)

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