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CompletedNCT05040412Updated Sep 10, 2021

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

An interventional study of difficult laryngoscopy in Diabetes Mellitus, sponsored by Bagcilar Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-10.

Sponsored by Bagcilar Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Jan 2020, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
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Study summary

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).

Read the detailed description

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.

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Conditions studied

  • Diabetes Mellitus

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Keywords

  • Diabetes mellitus, difficult laryngoscopy, insulin
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 192 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Bagcilar Training and Research Hospital is the lead sponsor of 54 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
192 participants (actual)

Study arms

  • Experimental
    Diabetic mellitus patients using insulin

    The trachea will be intubated by direct laryngoscopy.

    Device: difficult laryngoscopy

  • Experimental
    Diabetic patients using oral antidiabetic drug

    The trachea will be intubated by direct laryngoscopy.

    Device: difficult laryngoscopy

Interventions

  • Devicedifficult laryngoscopy

    Patients will be intubated with the direct laryngoscope.

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What researchers measure

Primary outcomes

  1. Intubation time

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

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

Secondary outcomes

  1. Intubation difficulty

    First attempt intubation success rate,numbers of attempt,Application of BURP manauver,number of alternative techniques

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

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Study locations

1 site
  • İstanbul Bagcilar Egitim ve arastirma hastanesi
    Istanbul, Bagcilar 34200, Turkey
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References and documents

Publications

  • Hashim K, Thomas M. Sensitivity of palm print sign in prediction of difficult laryngoscopy in diabetes: A comparison with other airway indices. Indian J Anaesth. 2014 May;58(3):298-302. doi: 10.4103/0019-5049.135042. PubMed 25024473 ↗
  • Warner ME, Contreras MG, Warner MA, Schroeder DR, Munn SR, Maxson PM. Diabetes mellitus and difficult laryngoscopy in renal and pancreatic transplant patients. Anesth Analg. 1998 Mar;86(3):516-9. doi: 10.1097/00000539-199803000-00012. PubMed 9495404 ↗
  • Mashour GA, Kheterpal S, Vanaharam V, Shanks A, Wang LY, Sandberg WS, Tremper KK. The extended Mallampati score and a diagnosis of diabetes mellitus are predictors of difficult laryngoscopy in the morbidly obese. Anesth Analg. 2008 Dec;107(6):1919-23. doi: 10.1213/ane.0b013e31818a9946. PubMed 19020139 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05040412
Lead sponsor
Bagcilar Training and Research Hospital
Responsible party
Kerem Erkalp (Professor, Bagcilar Training and Research Hospital) — Principal investigator
First posted
Sep 10, 2021
Start date
Jan 25, 2020
Primary completion
Apr 30, 2020
Completion
May 15, 2020
Last update
Sep 10, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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