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A study on decreasing the Blood pressure and heart rate under Anaesthesia

A Randomised Control Study On Nebulized Fentanyl, Dexmedetomidine And Magnesium Sulfate For Attenuation Of Hemodynamic Response To Laryngoscopy And Tracheal Intubation In Cardiac Patients Undergoing Non Cardiac Surgery. - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099767
Enrollment
132
Registered
2025-12-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I30-I52- Other forms of heart disease

Interventions

Intervention1: Nebulisation with Dexmedetomidine: nebulising the patient with dexmedetomidine 1 mcg/kg with romsons aeromist nebuliser 30 minutes before induction of anaesthesia and to look for attenu

Sponsors

M Nilaa Rajeswari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with ASA I - lll 2.Patients with EF between 40% - 60% 3.Cardiac patients undergoing elective non cardiac surgery ( like laparoscopic abdominal surgeries, head and neck surgeries)

Exclusion criteria

Exclusion criteria: 1.Known drug allergies to Fentanyl, Dexmedetomidine, Magnesium sulfate 2.Other comorbids like respiratory illness, patient on dialysis 3.Advanced cardiac illness like severe triple vessel disease, patient in cardiac failure, unstable angina, hypertrophic obstructive cardiomyopathy

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of nebulised fentanyl, dexmedetomidine, and magnesium sulphate in attenuating the haemodynamic response (heart rate and blood pressure changes) associated with laryngoscopy and tracheal intubation.Timepoint: T0: Baseline vitals- HR, SBP, DBP, MAP, RR, SpO2, EtCO2 - recorded in the preoperative room T1-T6: Post- nebulisation vitals recorded every 5 minutes for 30 minutes T7-T12: Post- intubation vitals recorded every 5 minutes for 30 minutes T13,T14,T15: Recorded at 1 hour, 1.5 hours and 2 hours after intubation.

Secondary

MeasureTime frame
To look for perioperative hemodynamicsTimepoint: Every 5 minutes;To evaluate the incidence of adverse effects associated with each of the three nebulised agents like bradycardia, hypotension, decreased urinary output, absent knee jerk, decreased respiratory rateTimepoint: Every one hour;To measure serum cortisol level in view of stress responseTimepoint: After intubation

Countries

India

Contacts

Public ContactNilaa Rajeswari M

SRM Medical College Hospital and Research centre

pushpara1@srmist.edu.in9003242601

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026