Assessing the effects of intravenous dexmedetomidine on heart rate, blood pressure and bispectral index during endotracheal intubation under general anaesthesia

Recruiting

• Conditions: Diseases of the ear and mastoid process,

• Registration Number: CTRI/2020/09/027752
• Lead Sponsor: K S Hegde Medical Academy

Brief Summary

**BACKGROUND**

Laryngoscopy and intubation being noxious stimuli,elicits remarkable sympathetic activity. It causes abrupt rise in the blood pressureand heart rate which returns to baseline values after cessation of the stimulus.

**Aim:**

To assess the effectiveness of dexmedetomidine in attenuating  intubation response with bispectral index(BIS) monitoring

**Objectives:**

Primary objective is to observe the BIS index alongwith haemodynamic changes during laryngoscopy and intubation. The adverseeffects like sedation and arrhythmias are noted as secondary objectives.

**Method:**

After approval of Institutional Ethics Committee, 40 patientsbelonging to AmericanSociety of Anaesthesiologists (ASA) class I, II, aged 18 to 60 years will be included with informed consent.Patients will be  divided into group D (Dexmedetomidine) and group C(Control), and IVinfusion of dexmedetomidine 1mcg/kg in 100ml of normal saline and plain 100 mlnormal saline will be given to respective groups over 15-20 min before induction. Haemodynamicparameters like HR, SBP, DBP, MAP and BISindex will be monitoredand documented at baseline, before induction, before laryngoscopy, postintubation, every minute after intubation till the next 10 minutes. Mann Whitney U test will be used forStatistical analysis of the mean changes of  the above parameters. ChiSquare test will be used for analysis of age, sex, weight, duration of laryngoscopyin both the groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-09
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

ASA PS I and II.

Exclusion Criteria

Anticipated difficult airway Patients on beta blockers Pregnant and lactating patients Patients refusal Allergic to drugs used in the study Baseline heart rate less than 50 bpm.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effects of dexmedetomidine on heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and bispectral index during intubation response	From baseline to ten minutes post intubation

Secondary Outcome Measures

Name	Time	Method
To assess any adverse reactions such as sedation, arrthymias etc

Trial Locations

Locations (1)

K S Hegde Medical Academy; 🇮🇳 Kannada, KARNATAKA, India

K S Hegde Medical Academy

🇮🇳Kannada, KARNATAKA, India

Sachin S

Principal investigator

9483625398

sachinshanmukhappa@gmail.com