Evaluating a Novel Intranasal Drug Delivery System for Procedural Sedation in Adults Undergoing Endoscopic Procedures – A Prospective, Comparative Study
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Abstract
Background: Intranasal drug delivery system has several advantages, but evidence associated with their use in patients is limited. This study evaluated the effectiveness of a novel drug delivery system for procedural sedation in adults undergoing endoscopic procedures at a tertiary care Indian centre.
Methodology: A prospective, comparative study was conducted at Sir H.N. Reliance Foundation Hospital & Research Centre (HNRFHRC) in Mumbai (India), including all adult patients posted for gastrointestinal endoscopy between July 2023 and June 2024. Enrolled patients were randomized to receive pre-operative medications by standard protocol (group 1) or intranasally (group 2). The intranasal approach involved attaching the cannula and nozzle of a standard lignocaine nasal spray to a syringe using a 20G needle. All patients were monitored using pulse oximetry, continuous electrocardiography, and noninvasive blood pressure measurements. Standardized assessment tools were used to evaluate the system: Amsterdam Preoperative Anxiety and Information Scale (APAIS), functional mobility scale (FMS), visual analogue scale (VAS) for pain, Observer’s Assessment of Alertness and Sedation (OAA/S), and 24-hour postoperative anxiety score (PAS).
Results: Of the 319 patients enrolled (166 control, 153 test), age, gender, and anthropometric characteristics were comparable (p > 0.05). Hemodynamic parameters and oxygen saturation were similar across groups (p > 0.05). The mean APAIS was significantly lower in the test group (p < 0.05), while OAA/S was comparable (p > 0.05). More patients in the test group had a VAS score of zero (92.16% vs. 69.88%, p < 0.05). Higher proportions in the control group had an FMS score of 2 or 3 (7.23% vs. 0%, p < 0.05) and PAS >18 (5.42% vs. 0%, p < 0.05). These findings demonstrate that the intranasal system reduces anxiety and pain and represents a conceptual advance, showing that a simple, low-cost modification can enhance peri-procedural comfort without compromising safety.
Conclusion: The novel intranasal drug delivery system improved pre-operative anxiety, immediate pain control, alertness, and postoperative anxiety. Further studies are warranted.
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1. Borrat X, Valencia JF, Magrans R, Gimenez-Mila M, Mellado R, Sendino O, et al. Sedation-analgesia with propofol and remifentanil: concentrations required to avoid gag reflex in upper gastrointestinal endoscopy. Anesth Analg. 2015;121(1):90-96. Available from: https://doi.org/10.1213/ane.0000000000000756
2. Zuccaro G Jr. Sedation and sedationless endoscopy. Gastrointest Endosc Clin N Am. 2000;10(1):1-20, v. Available from: https://pubmed.ncbi.nlm.nih.gov/10618451/
3. Gänger S, Schind K. Tailoring formulations for intranasal nose-to-brain delivery: a review on architecture, physico-chemical characteristics and mucociliary clearance of the nasal olfactory mucosa. Pharmaceutics. 2018;10(3):116. Available from: https://doi.org/10.3390/pharmaceutics10030116
4. Keller LA, Merkel O, Popp A. Intranasal drug delivery: opportunities and toxicologic challenges during drug development. Drug Deliv Transl Res. 2022;12(4):735-757. Available from: https://doi.org/10.1007/s13346-020-00891-5
5. Huang Q, Chen X, Yu S, Gong G, Shu H. Research progress in brain-targeted nasal drug delivery. Front Aging Neurosci. 2024;15:1341295. Available from: https://doi.org/10.3389/fnagi.2023.1341295
6. Khatri DK, Preeti K, Tonape S, Bhattacharjee S, Patel M, Shah S, et al. Nanotechnological advances for nose-to-brain delivery of therapeutics to improve Parkinson's therapy. Curr Neuropharmacol. 2023;21(3):493-516. Available from: https://doi.org/10.2174/1570159x20666220507022701
7. Manji J, Singh G, Okpaleke C, Dadgostar A, Al-Asousi F, Amanian A, et al. Safety of long-term intranasal budesonide delivered via the mucosal atomization device for chronic rhinosinusitis. Int Forum Allergy Rhinol. 2017;7(5):488-493. Available from: https://doi.org/10.1002/alr.21910
8. Fuehner T, Fuge J, Jungen M, Buck A, Suhling H, Welte T, et al. Topical nasal anesthesia in flexible bronchoscopy--a cross-over comparison between two devices. PLoS One. 2016;11(3):e0150905. Available from: https://doi.org/10.1371/journal.pone.0150905
9. Varricchio A, Brunese F, La Mantia I, Ascione E, Ciprandi G. Choosing nasal devices: a dilemma in clinical practice. Acta Biomed. 2023;94(1):e2023034. Available from: https://doi.org/10.23750/abm.v94i1.13738
10. Kundoor V, Dalby RN. Effect of formulation- and administration-related variables on deposition pattern of nasal spray pumps evaluated using a nasal cast. Pharm Res. 2011;28(8):1895-904. Available from: https://doi.org/10.1007/s11095-011-0417-6
11. Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996;82(3):445-51. Available from: https://doi.org/10.1097/00000539-199603000-00002
12. Bagchi D, Mandal MC, Das S, Basu SR, Sarkar S, Das J. Bispectral index score and observer's assessment of awareness/sedation score may manifest divergence during onset of sedation: study with midazolam and propofol. Indian J Anaesth. 2013;57(4):351-7. Available from: https://doi.org/10.4103/0019-5049.118557
13. Spielberger CD. State-trait anxiety inventory. In: Weiner IB, Craighead WE, editors. The Corsini Encyclopedia of Psychology. 2010. Available from: https://doi.org/10.1002/9780470479216.corpsy0943
14. Knoester PD, Jonker DM, Van Der Hoeven RT, Vermeij TA, Edelbroek PM, Brekelmans GJ, et al. Pharmacokinetics and pharmacodynamics of midazolam administered as a concentrated intranasal spray: a study in healthy volunteers. Br J Clin Pharmacol. 2002;53(5):501-7. Available from: https://doi.org/10.1046/j.1365-2125.2002.01588.x
15. Musani IE, Chandan NV. A comparison of the sedative effect of oral versus nasal midazolam combined with nitrous oxide in uncooperative children. Eur Arch Paediatr Dent. 2015;16(5):417-24. Available from: https://doi.org/10.1007/s40368-015-0187-7
16. Mohandas A, Luo H, Ramakrishna S. An overview on atomization and its drug delivery and biomedical applications. Applied Sciences. 2021;11(11):5173. Available from: https://doi.org/10.3390/app11115173
17. Bourganis V, Kammona O, Alexopoulos A, Kiparissides C. Recent advances in carrier-mediated nose-to-brain delivery of pharmaceutics. Eur J Pharm Biopharm. 2018;128:337-62. Available from: https://doi.org/10.1016/j.ejpb.2018.05.009
18. Erdő F, Bors LA, Farkas D, Bajza Á, Gizurarson S. Evaluation of intranasal delivery route of drug administration for brain targeting. Brain Res Bull. 2018;143:155-70. Available from: https://doi.org/10.1016/j.brainresbull.2018.10.009
19. Gizurarson S. Anatomical and histological factors affecting intranasal drug and vaccine delivery. Curr Drug Deliv. 2012;9(6):566-82. Available from: https://doi.org/10.2174/156720112803529828
20. Chung S, Peters JM, Detyniecki K, Tatum W, Rabinowicz AL, Carrazana E. The nose has it: opportunities and challenges for intranasal drug administration for neurologic conditions, including seizure clusters. Epilepsy Behav Rep. 2022;21:100581. Available from: https://doi.org/10.1016/j.ebr.2022.100581
21. Crowe TP, Greenlee MHW, Kanthasamy AG, Hsu WH. Mechanism of intranasal drug delivery directly to the brain. Life Sci. 2018;195:44-52. Available from: https://doi.org/10.1016/j.lfs.2017.12.025
22. Lochhead JJ, Thorne RG. Intranasal delivery of biologics to the central nervous system. Adv Drug Deliv Rev. 2012;64(7):614-28. Available from: https://doi.org/10.1016/j.addr.2011.11.002