Dexmedetomidine causes change in vital parameters after intubation

Phase 1/2

Active, not recruiting

• Conditions: ASA Grade I & II patients

• Registration Number: CTRI/2018/04/013000
• Lead Sponsor: ESIPGIMSR and Model hospital andheri

Brief Summary

"Attenuation of pressor response to

laryngoscopy and tracheal intubation in adult patients with intravenous

Dexmedetomidine†was carried out at tertiary center . 100 patients scheduled for

various elective surgical procedures belonging to ASA class I and II, in the age group

of 18 to 60 years were included in the study. The patients with hypertension, difficult

airway, obesity and any other systemic disorders were excluded from the study. The

study population was divided randomly into two groups of 50 each.

Group 1 (Dexmedetomidine) patients received IV Dexmedetomidine 1 microgram /kg

in 100ml normal saline infused over 10 min before induction

Group 2 (Saline) patients received 100 ml normal saline infused over 10 min before

induction.

All patients were Premedicated with Inj. Glycopyrrolate 0.004mg/kg, Inj.

Ondansetron 0.08mg/kg, Inj. Ranitidine 50 mg was given intravenously. Inj.

Pentazocine 0.5mg/kg and Inj. Midazolam 0.03 mg/kg were administered IV slowly.

Anaesthesia was induced with a 1% (w/v) solution of propofol 2mg/kg injected at a

rate of approximately 10mg/sec, the endpoint being the loss of the eyelash reflex.

after successful trial ventilation scholine 1.5 mg/kg was given to facilitate

laryngoscopy and intubation.

After Laryngoscopy and intubation the HR, SBP, DBP and MAP were recorded at 0

min, 5 and 10 min after intubation.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-12
• Last Update Posted: 2018-03-24

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient posted for surgery under general anesthesia.
• Patients belonging to ASA class I & II.

Exclusion Criteria

• 1 Patients with hypertension, cardiac, respiratory, renal, hepatic & cerebral diseases 2.
• Patients with difficult airway and obese patients.
• Patients with endocrinal diseases like hyperthyroidism, hypothyroidism and diabetes mellitus.
• Pregnant patient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To study the efficacy of 1μg/kg dexmedetomidine intravenous given in 100	Baseline, at 5 and 10 mins during drug infusion, after induction, at and 5,10 mins after intubation
ml NS over 10 minutes before induction to obtund the pressor response of	Baseline, at 5 and 10 mins during drug infusion, after induction, at and 5,10 mins after intubation
laryngoscopy and tracheal intubation with respect to- Heart rate, systolic blood	Baseline, at 5 and 10 mins during drug infusion, after induction, at and 5,10 mins after intubation
pressure, diastolic blood pressure, Mean arterial pressure.	Baseline, at 5 and 10 mins during drug infusion, after induction, at and 5,10 mins after intubation

Secondary Outcome Measures

Name	Time	Method
To study any adverse effects associated, such as perioperative	hypotension, bradycardia.

Trial Locations

Locations (1)

ESIPGIMSR and Model Hospital Andheri Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

ESIPGIMSR and Model Hospital Andheri Mumbai

🇮🇳Mumbai, MAHARASHTRA, India

Dr Gajanan Sanjay More

Principal investigator

8975977409

gajuraje81@gmail.com