The Challenge of Preoperative Anxiety and Pain in Procedural Sedation
Preoperative anxiety affects up to 80% of patients undergoing medical procedures, heightening pain perception and complicating sedation efforts. In gastrointestinal endoscopy, a common diagnostic tool, patients often dread the insertion of intravenous lines and the uncertainty of sedation. Traditional methods rely on IV administration of agents like ketamine, midazolam, and fentanyl, but these can trigger fears of needles and cause postoperative nausea or vomiting. This Mumbai-based innovation addresses these pain points head-on, offering a needle-free alternative that transforms patient experience.
Innovation in Intranasal Drug Delivery for Sedation
Intranasal routes leverage the nose's rich vascular supply for rapid absorption, bypassing first-pass metabolism and providing quick onset comparable to IV. Drugs like midazolam and ketamine have established intranasal efficacy in pediatrics, but adult procedural sedation data was sparse until this study. The modification—attaching a standard lignocaine nasal spray nozzle to a syringe via 20G needle—enables precise dosing at a 30-45° angle, targeting olfactory mucosa for optimal uptake. This low-cost hack democratizes advanced sedation in resource-limited settings.
Overview of the Mumbai Prospective Study
Conducted at Sir H. N. Reliance Foundation Hospital & Research Centre in Mumbai from July 2023 to June 2024, this prospective comparative trial enrolled 319 adults (166 control, 153 test) for upper and lower gastrointestinal endoscopy. Led by Consultant Anaesthesiologists Misha Mehta and Aditi Kadakia, with Chair Hemant Mehta, the study randomized patients to standard IV premedication (lignocaine 40mg IV, ketamine 20mg IV, fentanyl 50mcg IV, midazolam 1mg IV) or intranasal equivalents (ketamine 40mg, midazolam 1mg, lignocaine 20mg IN). Propofol boluses supplemented as needed. Institutional Review Board approved, with informed consent.
Defining Key Assessment Tools
Outcomes were rigorously measured:
- Amsterdam Preoperative Anxiety and Information Scale (APAIS): 6-item Likert scale assessing procedure-specific anxiety.
- Visual Analogue Scale (VAS) for Pain: 0-10 scale post-procedure at 1 hour.
- Observer’s Assessment of Alertness/Sedation (OAA/S): 1-5 scale for sedation depth.
- Functional Mobility Scale (FMS): 0-5 for post-procedure ambulation.
- Postoperative Anxiety Score (PAS): Spielberger State-Trait Anxiety Inventory at 24 hours.
Striking Results: Anxiety and Pain Reduction
The intranasal group shone: mean APAIS 12.84 ± 4.76 vs. 20.34 ± 6.75 control (p < 0.05). Pain-free (VAS=0) in 92.16% test vs. 69.88% control (p < 0.001). No test patients had FMS 2-3 (impaired mobility), vs. 7.23% control (p < 0.05). 24-hour PAS lower (12.20 ± 1.28 vs. 12.83 ± 2.29, p < 0.05), with 0% high anxiety (>18) in test vs. 5.42% control. OAA/S comparable (4.78 ± 0.64 vs. 4.61 ± 0.63). These stats underscore superior comfort without deeper sedation.
| Outcome | Control (IV) | Test (IN) | p-value |
|---|---|---|---|
| APAIS mean | 20.34 ± 6.75 | 12.84 ± 4.76 | <0.05 |
| VAS=0 (%) | 69.88% | 92.16% | <0.001 |
| FMS 2-3 (%) | 7.23% | 0% | <0.05 |
| PAS >18 (%) | 5.42% | 0% | <0.05 |
Safety and Hemodynamic Stability Confirmed
No adverse events reported. Heart rate, blood pressure, and SpO2 remained stable across groups (p > 0.05 at all intervals). This affirms intranasal safety for endoscopy, where rapid recovery is paramount. Doses doubled for ketamine IN due to bioavailability (~45-50%), yet no hypotension or desaturation occurred.Full study details
Comparative Context: Building on Global Research
Prior studies support: intranasal dexmedetomidine reduces emergence agitation in ENT surgery; midazolam-ketamine combos effective in pediatrics. India's context adds value—high endoscopy volume (~2 million/year), needle phobia prevalent. This low-tech adaptation suits public hospitals overburdened by IV setups.
Implications for Indian Healthcare and Medical Training
In India, where 70% of surgeries occur in resource-constrained settings, this could cut recovery times, reduce nausea (common IV side-effect), and ease nursing burden. For endoscopy centers in tier-2 cities, it's scalable. Medical colleges training anesthesiologists can incorporate: hands-on nasal delivery simulations enhance procedural skills. Aspiring professionals, explore faculty positions in anesthesiology or research roles advancing sedation tech.
Stakeholder Perspectives: Doctors Weigh In
Dr. Misha Mehta: "Intranasal achieved better pain control, mobility, lower anxiety." Dr. Hemant Mehta highlights trance-like sedation easing OT fears. Dr. Ashish Mali (Nair Hospital): Useful for dentistry, pediatrics, MRI; IV preferred for majors.TOI coverage
- Benefits: Needle-free, rapid onset, cost-effective.
- Risks: Nasal pathology contraindications; not for deep sedation.
- Comparisons: Faster than oral, less invasive than IM.
Future Outlook: Scaling and Research Frontiers
Trials for broader applications (MRI, dental) needed; pharma could standardize sprays. NEP 2020 emphasizes interdisciplinary research—med-tech collaborations key. In Mumbai's ecosystem, ties to IITs/Bombay Hospital could refine delivery devices. For careers, craft your CV for anesthesiology residencies; check Mumbai jobs.
Photo by ShareYaarNow on Unsplash
Actionable Insights for Clinicians and Trainees
Implement: Pilot in endoscopy units; train on angle/technique. Students: Shadow anesthesiologists, contribute to trials. Position as trusted source, explore Rate My Professor for mentors, higher ed jobs, career advice.
