Changes in blood pressure and cough reflex during tracheostomy tube change by using two different drugs.

Not yet recruiting

• Conditions: Unspecified intracranial injury,

• Registration Number: CTRI/2022/01/039224
• Lead Sponsor: Trauma Centre

Brief Summary

After obtaining written and informed consent from the patients relative, the patients will be divided randomly using computer generated number and concealed using sequentially numbered, sealed opaque envelope technique into two equal groups(each 50 patients):

Group D: Will receive Dexmedetomidine 0.5 mcg/kg diluted in 25 ml of normal saline IV over a period of 10 minutes, before the procedure.

Group F:Will receive Fentanyl 1 mcg/kg diluted in 25 ml of normal saline IV over a period of 10 minutes, before the procedure.

The nature and safety of the procedure will be explained, written and informed consent will be obtained. After confirming the fasting status, baseline Non Invasive Blood Pressure (NIBP), Heart Rate (HR) and Oxygen Saturation (SpO2) will be recorded. Hemodynamic variables will be measured-baseline before drug administration 5 and 10 minutes after respective drug administration. Under aseptic precautions tracheostomy tube will be changed after intravenous administration of the respective studied drugs. Hemodynamic variables will be recorded at 1,3,5,10,15 and 30 minutes after the procedure. Time taken for changing tracheostomy tube will be recorded. Grading of cough was noted as a measure of response to tracheal stimulation. Coughing after the change of tube was assessed using a 5 point scale:

1. No cough, easy breathing.

2. Slight cough (one or two), easy breathing.

3. Moderate coughing (three or four).

4. Heavy coughing, breathing hard.

5. Laryngospasm, severe coughing and hardly breathing.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-04-01
• Study Start: 2022-10-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.Head injury patients on tracheostomy tube.
• 2.Age group between 18 and 60 years.

Exclusion Criteria

• 1.Cervical spine injury.
• 2.Heart Rate below 60/min.
• 3.Arterial pressure less than 100/60 mm of Hg. 4.History of allergic reaction to the study mentioned drugs.
• 5.Refusal to take part in the study.
• 6.Patients with COPD/Asthma/Diabetes/Hypertension.
• 7.Patients on Neuromuscular blockers or any sedative drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemodynamic parameters and cough reflex	0,1,3,5,10,15 and 30 min

Secondary Outcome Measures

Name	Time	Method
associated adverse events	0,1,3,5,10,15 and 30 min

Trial Locations

Locations (1)

Institute of medical sciences(IMS); 🇮🇳 Varanasi, UTTAR PRADESH, India

Institute of medical sciences(IMS)

🇮🇳Varanasi, UTTAR PRADESH, India

Dr Erra Anuhya

Principal investigator

7416863020

anuhyaerra92@gmail.com