Diabetes MellitusNCT05040412
Comparison of the Patients With Diabetes Mellitus Using Either Insulin or Oral Antidiabetic Drug In Terms Of Difficult Laryngoscopy
A study testing difficult laryngoscopy in people with Diabetes Mellitus, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- difficult laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2020to 15 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Emergency surgery
- Difficult intubation story
- İmpaired airway anatomy
- Morbidly obese (BMI > 40 kg/m2)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Bagcilar Egitim ve arastirma hastanesi
Istanbul, Bagcilar, 34200
About this study
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.
- Conditions
- Diabetes Mellitus
- Being tested
- difficult laryngoscopy
- Keywords
- Diabetes mellitus, difficult laryngoscopy, insulin
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
difficult laryngoscopyDevice
Patients will be intubated with the direct laryngoscope.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic mellitus patients using insulin | Experimental | The trachea will be intubated by direct laryngoscopy. Receives: Device: difficult laryngoscopy |
| Diabetic patients using oral antidiabetic drug | Experimental | The trachea will be intubated by direct laryngoscopy. Receives: Device: difficult laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
Mallampati class,Thyromental distance,Cormack Lehane classification,Intubation time
Measured: 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
Measured: -120 seconds after intubation.The time elapsed between the passage of the larygoscope through the teeth and the detection of ETCO2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start25 Jan 2020
- Primary completion30 Apr 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomised
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kerem Erkalp, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040412
- Sponsor's protocol ID
- 2020.01.2.05.015
- Status last verified
- Sep 2021
- First submitted
- 2 Sep 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 25024473Warner 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 9495404Mashour 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Patients With Diabetes Mellitus Using Either Insulin or Oral Antidiabetic Drug In Terms Of Difficult Laryngoscopy
- ClinicalTrials.gov ID
- NCT05040412
- Acronym / sponsor ID
- 2020.01.2.05.015
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus, difficult laryngoscopy, insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 25 Jan 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective randomised
| Arm | Type | Receives |
|---|---|---|
| Diabetic mellitus patients using insulin | Experimental | Device: difficult laryngoscopyThe trachea will be intubated by direct laryngoscopy. |
| Diabetic patients using oral antidiabetic drug | Experimental | Device: difficult laryngoscopyThe trachea will be intubated by direct laryngoscopy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- Emergency surgery
- Difficult intubation story
- İmpaired airway anatomy
- Morbidly obese (BMI > 40 kg/m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| difficult laryngoscopyPatients will be intubated with the direct laryngoscope. | Device | Diabetic mellitus patients using insulin, Diabetic patients using oral antidiabetic drug |
Primary outcome
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
Mallampati class,Thyromental distance,Cormack Lehane classification,Intubation time
1 secondary outcome
Intubation difficulty
Time frame: -120 seconds after intubation.The time elapsed between the passage of the larygoscope through the teeth and the detection of ETCO2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Results publication: PubMed 25024473Hashim 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.
- Results publication: PubMed 9495404Warner 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.
- Results publication: PubMed 19020139Mashour 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.
- Kute R, Gosavi R, Bhaleker P, Phalgune D. Predictability of airway evaluation indices in diabetic and nondiabetic patients requiring general anesthesia with endotracheal intubation. Indian Anaesth Forum 2019;20:70-5Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing difficult laryngoscopy in people with Diabetes Mellitus, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05040412, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.