Randomised trial comparing the efficacy of pre-operative Nebulised Dexmedetomidine with Nebulised Lignocaine in attenuation of hemodynamic pressor response to laryngoscopy and nasotracheal intubation-A Phase II study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Cancer Institute WIA
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Comparison of the efficacy of nebulised dexmedetomidine with nebulised lignocaine on attenuation of systolic blood pressure in patients undergoing laryngoscopy and nasotracheal intubation
Study Overview
Brief Summary
Endotracheal intubation is a highly stimulating procedure associated with a surge in catecholamine levels and significant hemodynamic alterations which may adversely impact postoperative outcomes, especially in patients with multiple comorbidities.Nasotracheal intubation has been found to be more hemodynamic changes due to the involvemnt of highly sensitive structures. Multiple drugs have been used but no ideal drug has been identified. Nebulised dexmedetomidine offers a novel solution to using its properties in attenuating the hemodynamic changes without any of its side effects. Nebulised lignocaine also has been studied extensively wrt to its effect on blunting the intubation response. However, these drugs have not been compared for their effects on nasotracheal intubation. It is being hypothesised that nebulised dexmedetomidine may be more effective than nebulised lignocaine based on previous research.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 85.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adults, both male and female, aged above 18years, coming for surgery under general anesthesia needing nasotracheal intubation, classified under ASA 1,2 status.
Exclusion Criteria
- •presence of heart block, asa 3-4, drug allergy to propofool, egg, cardiac dysfunction.
Outcomes
Primary Outcomes
Comparison of the efficacy of nebulised dexmedetomidine with nebulised lignocaine on attenuation of systolic blood pressure in patients undergoing laryngoscopy and nasotracheal intubation
Time Frame: before drug administration, induction and 10 minutes after nasotracheal intubation
Secondary Outcomes
- the effect of nebulised dexmed/lignocaine on heart rate, BP, sedation score, need for additional drugs to maintain hemoodynamic stability, the mean of the pre induction and post intubation HR, Mean arterial pressure and diastolic bp shall be compared, mean propofol requirement between the 2 groups shall be compared(pre drug, induction and 10 minutes post intubation)
Investigators
Dr.Pritha Raj
cancer institute