CTRI/2026/01/102099Not yet recruitingPhase 4
Efficacy of Intranasal Dexmedetomidine in suppressing haemodynamic stress response to Boyle Davis Mouth Gag insertion in patients undergoing Tonsillectomy - A Randomised Double Blinded Placebo Controlled Trial.
Mahatma Gandhi Medical College and Research Institute1 site in 1 country64 target enrollmentStarted: February 3, 2026Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 64
- Locations
- 1
Study Overview
Brief Summary
The primary purpose of this study is to evaluate the effectiveness of intranasal dexmedetomidine administered preoperatively in attenuating hemodynamic stress response to Boyle–Davis mouth gag application during tonsillectomy in paediatric patients (5–12 years) .This study hypothesize that intranasal dexmedetomidine, given as premedication, will reduce hemodynamic stress response , compared with standard care during tonsillectomy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 5.00 Year(s) to 14.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients aged between 5-14 years of age of either sex posted for elective tonsillectomy.
Exclusion Criteria
- •Patients with contraindications to Dexmedetomidine
- •Patients with history of congenital heart diseases, heart blocks, hypertension,pre existing sinus bradycardia,obstructive sleep apnoea.
- •Patients care givers not giving the consent.
Investigators
Narra Pavithra
Mahatma Gandhi Medical College and Research Institute , Pondicherry.
Study Sites (1)
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