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CTRI Number  CTRI/2012/08/002898 [Registered on: 22/08/2012] Trial Registered Retrospectively
Last Modified On: 25/07/2012
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Crossover Trial 
Public Title of Study   ICU patient response to tracheal suctioning with placebo, lignocaine or dexmedetomidine 
Scientific Title of Study   Effect of intravenous lidocaine and dexmedetomidine on response to tracheal suctioning in intensive care unit patients - A prospective, randomised, double blinded, cross over study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IEC 208/211  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Umesh Goneppanavar 
Designation  Associate Professor 
Affiliation  KMC, Manipal, Manipal University, India 
Address  Department of Anaesthesia, KMC, Manipal, India

Udupi
KARNATAKA
576 104
India 
Phone  9480575663  
Fax    
Email  drumeshg@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Swaroopa G 
Designation  Postgraduate student 
Affiliation  KMC, Manipal, Manipal University, India 
Address  Department of Anaesthesia, KMC, Manipal, India

Udupi
KARNATAKA
576 104
India 
Phone  9886947695  
Fax    
Email  dr.swaroopa@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Umesh Goneppanavar 
Designation  Associate Professor 
Affiliation  KMC, Manipal, Manipal University, India 
Address  Department of Anaesthesia, KMC, Manipal, India


KARNATAKA
576 104
India 
Phone  9480575663  
Fax    
Email  drumeshg@yahoo.co.in  
 
Source of Monetary or Material Support  
Kasturba Hospital, KMC, Manipal 
 
Primary Sponsor  
Name  Kasturba Hospital KMC Manipal 
Address  Kasturba Hospital, KMC, Manipal 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Umesh G  KMC, Manipal  Department of Anaesthesia, Kasturba Hospital, KMC, Manipal, Udupi district
Udupi
KARNATAKA 		 9480575663

drumeshg@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Kasturba Hospital, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ICU patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  dexmedetomidine  0.3 mcg/kg over 5 min IV 5 minutes prior to tracheal suctioning 
Intervention  dexmedetomidine  0.3 mcg/kg over 5 min IV 5 minutes prior to tracheal suctioning 
Intervention  lignocaine  1 mg/kg 1 minute prior to tracheal suctioning 
Comparator Agent  placebo  saline 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  All patients that have a tracheal tube in situ in ICU 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Numerical rating scale score
Behavioural response score
Haemodynamic fluctuations of 20% from baseline 		 Baseline, 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  
Outcome  TimePoints 
Complications
Arrhythmias, desaturation
 		 During study period, that is within 15 minutes after tracheal suctioning 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   21/09/2011 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

In our study, we evaluated the effects of two different pharmacological interventions (dexmedetomidine or lidocaine) on tracheal suctioning response.

Randomisation was done as per a computer generated randomisation table. The blinding was ensured in the following way:

Syringe A contained either dexmedetomidine or saline (10 mL) which was administered over 5 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 bolus injection at 4th minute.

At the end of 4th minute, patients received 100% oxygen for further 60 seconds. At the end of this, tracheal suctioning was carried out over 15 seconds with all aseptic precautions. The tracheal suction catheter size was determined by the following formula [Suction catheter size in French = (internal diameter of endotracheal tube in mm × 3) ÷ 2] and this was kept constant throughout the study for a given patient.

Richmond Agitation 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 rating scale) both prior to and after suctioning. Variables such as heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) or any change in the rhythm pattern including ectopics etc were noted. These variables were noted at every minute starting just prior to suctioning and till 5 minutes after suctioning and then they were noted at 10th and 15th minute.

 
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