A study to compare nebulized fentanyl, dexmedetomedine and magnesium sulphate for attenuation of stress response to laryngoscopy and intubation

Phase 3

Active, not recruiting

• Conditions: Measurement and Monitoring,

• Registration Number: CTRI/2021/09/036806
• Lead Sponsor: esic medical college and hospitalfaridabad

Brief Summary

direct laryngoscopy and intubation result in pressor response which is associated with increase in heart rate and blood pressure due to stimulation of sympathetic system. it can cause serious complications in patients of coronary artery disease, raised icp etcmany studies compare intravenous form we will compare nebulised dexmedetomedine, magnesium sulphate and fentanyl for attenuation of haemodynamic response to laryngoscopy and intubation

primary objective to evaluate pressoer  response. secondary outcome to record any side effects

this prospective .double blinded randomised study will be conducted in esic faridabad with above stated inclusion and exclusion criteria

statistical test anova with post hoc bonferroni correction for quantitative and chi square for qualitative data

preanaesthetic evaluation will be done. pt kept fasting by asa guidelines

informed written consent to be taken. randomisation with envelope method into 3 groups

preop vitals - heart rate. systolic bp , diastolic bp ,mean arterial pressure recorded



group a : nebilsation with  fentanyl 1mcg/kg in normal saline total 5 ml @ o2 6l/m before induction

group b:nebulisation with dexmedetomedine 1mcg/kg

group c: nebulisation with magnesium sulphate 40mg/kg max up to 2g



after neb pt taken in ot and hr.sbp.dbp.map recorded

preoxygenation done. premedication with inj fentanyl 2mcg/kg iv, induction with propofol 2mg/kg iv check ventilation vec 0.08mg/kg iv 3min ippv followed by dl scopy and intubation

2 min . 5 min and 10 min after intubation hr. sbp.dbp.map will be recordedno stimulus allowed during study period

fall in map>20% treated with inj ephedfrine 6mg iv and hr <45/min treated by atropin 0.6 mg iv

no ethical implications as these  drugs are routinely used in anaesthesia practice

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-25
• Last Update Posted: 2023-01-16

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patients between age of 18 and 60 yrs ASA grade 1 and 2 Patients undergoing elective surgery requiring general anaesthesia and endotracheal intubation Mallampati grading I to II.

Exclusion Criteria

Patient refusal Drug allergy Patient with apparent difficult airway Patients in ASA grade III & above Patients who require Intubation time > 20 sec Patients having BMI>30 Pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate attenuation of haemodynamic response to laryngoscopy and intubation	baseline reading, after nebulisation, 2min, 5min, 10 min after intubation

Secondary Outcome Measures

Name	Time	Method
adverse effect in any	2 min 5 min 10 min after intubation

Trial Locations

Locations (1)

esic faridabad; 🇮🇳 Faridabad, HARYANA, India

esic faridabad

🇮🇳Faridabad, HARYANA, India

dr niharika grover

Principal investigator

9811632907

drniharikagrover@yahoo.com