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ICU patient response to tracheal suctioning with placebo, lignocaine or dexmedetomidine

Phase 4
Recruiting
Conditions
ICU patients
Registration Number
CTRI/2012/08/002898
Lead Sponsor
Kasturba Hospital KMC Manipal
Brief Summary

Inour study, we evaluated the effects of two different pharmacologicalinterventions (dexmedetomidine or lidocaine) on tracheal suctioning response.

Randomisationwas done as per a computer generated randomisation table. The blinding wasensured in the following way:

**Syringe A**contained either dexmedetomidine or saline (10 mL) which was administered over5 minutes as an infusion starting from time 0 till 5th minute.

**Syringe B**contained either lidocaine or saline (5 mL) which was administered as a bolusinjection at 4th minute.

At the end of 4thminute, patients received 100% oxygen for further 60 seconds. At the end ofthis, tracheal suctioning was carried out over 15 seconds with all asepticprecautions. The tracheal suction catheter size was determined by the followingformula [Suction catheter size in French = (internal diameter of endotrachealtube in mm × 3) ÷ 2] and this was kept constant throughout the study for agiven patient.

RichmondAgitation Sedation Scale (RASS) was noted at the beginning of the study.Response to tracheal suctioning was assessed both objectively and subjectively.Observer 3 rated the pain / discomfort on a scale of 0-10 (numerical ratingscale) both prior to and after suctioning. Variables such as heart rate (HR),systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterialpressure (MAP) or any change in the rhythm pattern including ectopics *etc* were noted. These variables werenoted at every minute starting just prior to suctioning and till 5 minutesafter suctioning and then they were noted at 10th and 15thminute.

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
All
Target Recruitment
40
Inclusion Criteria

All patients that have a tracheal tube in situ in ICU.

Exclusion Criteria

1.Patients with known or suspected allergy to any of the study drugs (dexmedetomidine, lidocaine) 2.Patients with seizure disorder 3.Patients receiving neuromuscular blockade / with known neuromuscular disease 4.Patients who were hypotensive requiring more than one inotrope / vasopressor 5.Patients that were delirious or had disease condition that would confuse the behaviour assessment, such as decerebrate posturing.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Numerical rating scale scoreBaseline, at one minute interval for five minutes starting from the point of tracheal suctioning and at 10th and 15th minute following tracheal suctioning. | Behavioural response and numerical rating was assessed just prior to tracheal suctioning and in the following minute after tracheal suctioning
Behavioural response scoreBaseline, at one minute interval for five minutes starting from the point of tracheal suctioning and at 10th and 15th minute following tracheal suctioning. | Behavioural response and numerical rating was assessed just prior to tracheal suctioning and in the following minute after tracheal suctioning
Haemodynamic fluctuations of 20% from baselineBaseline, at one minute interval for five minutes starting from the point of tracheal suctioning and at 10th and 15th minute following tracheal suctioning. | Behavioural response and numerical rating was assessed just prior to tracheal suctioning and in the following minute after tracheal suctioning
Secondary Outcome Measures
NameTimeMethod
ComplicationsArrhythmias, desaturation

Trial Locations

Locations (1)

KMC, Manipal

🇮🇳

Udupi, KARNATAKA, India

KMC, Manipal
🇮🇳Udupi, KARNATAKA, India
Umesh G
Principal investigator
9480575663
drumeshg@yahoo.co.in

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