- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07633106
Effect of Adrenaline (1:80,000) Containing Local Anesthesia on Glycemic Level of Diabetic and Healthy Individuals Undergoing Tooth Extraction
Effect of Adrenaline (1:80,000) Containing Local Anesthesiaon Glycemic Level of Diabetic and Healthy Individuals Undergoing Tooth Extraction
Dental extraction is one of the most frequently performed surgical interventions worldwide, and local anaesthesia remains its pharmacological foundation.The addition of adrenaline (epinephrine) 1:80 000 to lignocaine 2 % is considered the gold-standard regimen because it prolongs pulpal anaesthesia, reduces peak plasma lignocaine levels, and improves operative visibility through local vasoconstriction. Nevertheless, adrenaline is a potent sympathomimetic amine that activates both α- and β-adrenergic receptors, thereby triggering metabolic cascades that can raise blood glucose. The clinical question is whether the minute doses deposited in the oral soft tissues (≈11 µg per cartridge) are sufficient to evoke a measurable hyperglycaemic response in normoglycaemic or diabetic individuals undergoing tooth extraction.
Published data are contradictory. A randomised crossover trial of 40 healthy volunteers reported a significant 0.59 mmol L-¹ increase in capillary glucose 30 min after 2 % lignocaine/1:80 000 adrenaline compared with 3 % prilocaine.[5,8]. Conversely, a larger observational study in Riyadh found no statistically significant glycaemic change in either well-controlled diabetics or normoglycaemic subjects receiving identical cartridges.[9] Discrepancies have been attributed to heterogeneous sample sizes (30-120 participants), variable timing of glucose measurement, failure to control for circadian cortisol peaks, and inconsistent exclusion of patients on β-blockers or metformin.Importantly, no multicentre trial has specifically isolated the 1:80 000 concentration; most investigations pooled 1:50 000, 1:100 000 and 1:200 000 formulations, limiting external validity to everyday dental practice.
The International Diabetes Federation (2021) estimates that 537 million adults live with diabetes, many of whom require urgent dental care. Even transient peri-operative hyperglycaemia (>10 mmol L-¹) can impair neutrophil chemotaxis, increase the risk of post-extraction alveolar osteitis and delay wound healing. Current UK and American dental guidelines offer conflicting advice: the Faculty of Dental Surgery (2019) states that vasoconstrictor concentrations ≤1:80 000 are "unlikely to cause clinically relevant hyperglycaemia," whereas the American Dental Association (2020) recommends "caution in insulin-dependent diabetics" without quantifying risk. A precise glycaemic profile following 1:80 000 adrenaline is therefore essential to inform evidence-based anaesthetic selection, pre-operative fasting instructions and post-operative glucose monitoring protocols, ultimately reducing diabetes-related morbidity in the dental chair.
METHOD 90 participants in total will be split into two equal groups for this study: Group A: Healthy individuals Group B: Individuals with a diagnosis of diabetes
The Institutional Ethical Review Board (IERB), Dow University of Health Sciences (DUHS), Karachi, will provide ethical permission for data collection before to start.
Every participant will receive complete information on the study's goals, methods, advantages, and any possible iside effects. They will be guaranteed that every piece of information gathered will be kept private and utilized only for study. Prior to inclusion, each subject will provide written informed permission.
A complete medical and dental history will be recorded, followed by a clinical examination to confirm eligibility. Participants will then be assigned to their respective groups.
The On Call EZ II Glucometer will be used to assess the blood glucose levels of both groups of patients prior to the administration of LA containing epinephrine (1: 80,000).
Prick finger with a lancet. Gently squeeze a tiny bit of blood onto the test strip from the base of the finger.
Then insert the strip into the meter. The blood sugar reading will show up within a few seconds.
- Monitor and document outcomes.
- Repeat the reading after 5 minutes
- Take one more reading after extraction All data will be documented in a structured proforma, including demographic details, medical history, type of diabetes management, pre- and post-extraction glucose readings, and any adverse events observed during the procedure.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Sindh
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Karachi, Sindh, Pákistán, 12345
- Dow University of Health and Sciences Karachi, Sindh
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria: For case group Patients with Diabetes Mellitus type II confirmed by HbA1c Patients with status of ASA I or II Patient undergoing nonsurgical extraction For control groupHealthy individuals having no diabetes Patient undergoing nonsurgical extraction
Exclusion Criteria: Patients who are allergic to local anesthesia Patients with systemic disease other than diabetesPregnant patient Patient not willing to participate in the study
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Diabetic patients
Administration of local anesthesia containing 1:80000 adrenaline to the diabetic patient prior to tooth extraction to monitor subsequent glycemic changes
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Administration of local anesthesia containing 1:80000 adrenaline prior to tooth extraction to monitor subsequent glycemic changes at baseline and post injection intervels
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Experimentální: Healthy individual
Administration of local anesthesia containing 1:80000 adrenaline to healthy non diabetic individual prior to tooth extraction to monitor subsequent glycemic changes
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Administration of local anesthesia containing 1:80000 adrenaline prior to tooth extraction to monitor subsequent glycemic changes at baseline and post injection intervels
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Effect of adrenaline (1:80,000) containing local anesthesia on glycemic level of diabetic patients and healthy individuals undergoing tooth extraction
Časové okno: half hour
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half hour
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Effect of adrenaline (1:80,000) containing local anesthesia on glycemic level of diabetic patients and healthy individuals undergoing tooth extraction
Časové okno: 15-20mins
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15-20mins
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Effect of adrenaline (1:80,000) containing local anesthesia on glycemic level of diabetic patients and healthy individual undergoing tooth extraction
Časové okno: half hour
|
half hour
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Dr hadiqa noor, Dr Ishrat ul Ebad Khan Institute of Oral Health Sciences
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB-4404/DUHS/Approval/2025/50
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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