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CTRI Number  CTRI/2020/01/022959 [Registered on: 27/01/2020] Trial Registered Prospectively
Last Modified On: 17/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between Dexmedetomidine alone versus Dexmedetomidine plus Ketamine combination during awake fiberoptic nasotracheal intubation on sedation and patients satisfaction. 
Scientific Title of Study   Comparison of intravenous Dexmedetomidine alone versus Dexmedetomidine plus Ketamine combination on sedation, intubation response, safety profile and patient satisfaction during awake fiberoptic nasotracheal intubation. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MAGNANI VANDANA RAMCHAND 
Designation  2nd year resident 
Affiliation  SSG hospital, vadodara. 
Address  Department of Anaesthesiology, medical college and SSG hospital, Vadodara
Department of Anaesthesiology, medical college and SSG hospital, Vadodara
Vadodara
GUJARAT
390001
India 
Phone  9712911845  
Fax    
Email  vanduswt97129@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Kavita lalchandani 
Designation  Associate professor 
Affiliation  SSG hospital baroda 
Address  Department of anaesthesiology medical college and SSG hospital Vadodara
Department of anaesthesiology medical college and SSG hospital Vadodara
Vadodara
GUJARAT
390001
India 
Phone  9274586809  
Fax    
Email  lalchandanikavita@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  DR Kavita lalchandani 
Designation  Associate professor 
Affiliation  SSG hospital baroda 
Address  Department of anaesthesiology medical college and SSG hospital Vadodara
Department of anaesthesiology medical college and SSG hospital Vadodara
Rajkot
GUJARAT
390001
India 
Phone  9274586809  
Fax    
Email  lalchandanikavita@yahoo.in  
 
Source of Monetary or Material Support  
SSG Hospital baroda 
 
Primary Sponsor  
Name  SSG hospital baroda 
Address  Department of anaesthesiology medical college and SSG hospital baroda 
Type of Sponsor  Government medical college 
 
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 
DR Vandana Magnani  SSG hospital baroda  Department of anaesthesiology medical college and SSG hospital baroda
Vadodara
GUJARAT 
9712911845

vanduswt97129@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
InstitutionalEthicsCommitteeforHumanResearchPostgraduateResearch  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S098||Other specified injuries of head,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  COMPARISON BETWEEN DEXMEDETOMIDINE ALONE VERSUS DEXMEDETOMIDINE AND KETAMINE COMBINATION DURING FIBER OPTIC NASOTRACHEAL INTUBATION  INTRAVENOUS DEXMEDETOMIDINE (1MICRO GM/KG) ALONE IN CONTROL GROUP AND DEXMEDETOMIDINE WITH INTRAVENOUS KETAMINE (15 MILI GM) IN STUDY GROUP ON EVALUATION OF SEDATION INTUBATION RESPONSES SAFETY PROFILE AND PATIENTS SATISFACTION DURING FIBER OPTIC NASOTRACHEAL INTUBATION 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA grade I and II
MPG grade I II and III
Patients posted for elective surgery under general anaesthesia 
 
ExclusionCriteria 
Details  Patient refusal
Patient with history of allergy to Dexmedetomidine and Ketamine
Patients on anticoagulants or having thrombocytopenia or coagulopathies
Nasal trauma polyp and deformity
pregnancy and nursing mother
obstructive sleep apnoea
Patients with history of hypertension bradycardia psychiatric illness patient with raised ICT
patients taking alpha antagonists antihypertensives antidepressants antipsychotic drugs
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Ramsay sedation score  10 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Intubation response
Safety profile interms of haemodynaemic stability 
Intraoperatively 
Patients Satisfaction interms of recall and pain during procedure  24 hour 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   30/01/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Awake fiberoptic intubation is useful in cases of anticipated difficult airway, failed intubation, nil mouth opening and unstable cervical spine injury where optimum positioning for laryngoscopy is difficult to achieve. It is done with help of Flexible fibreoptic bronchoscope.
The Flexible fibreoptic bronchoscope is a flexible instrument which is capable of transmitting an image from the distal tip to the proximal end. The motion of the tip of the fiberscope can be controlled which enables the operator to direct the scope in any desired direction. The combined characteristics of controllability, flexibility and image transmission permit an anesthesiologist to employ the fiberscope as an aid to tracheal intubation. Intravenously used Dexmedetomidine is a highly selective and specific alpha 2 adreno receptor agonist. It is well known for its cooperative sedation property. It has  anxiolytic, analgesic, sedative, sympatholytic, and antisecretory properties. It has minimal  respiratory depression and easy arousability. And stress response to intubation is also minimized. However, it may produce bradycardia and hypotension occasionally. Addition of low dose of Ketamine, a sympathomimetic intravenous induction agent with potent analgesic properties,  to Dexmedetomidine  provides additional analgesic effect and helps in preventing Dexmedetomidine induced bradycardia and hypotension, while undesirable increase in airway secretion with Ketamine is attenuated by Dexmedetomidine. Opposing action of Ketamine and Dexmedetomidine on cardiac and sympathetic system provide more stable hemodynamic response apart from better sedation and intubation condition.

The aims of the study are –

To Evaluate the effect of addition of intravenous Ketamine to Dexmedetomidine and compare with Dexmedetomidine alone during awake nasotracheal fiberoptic  on   following parameters:

      Sedation during the procedure judged by Ramsay sedation score starting before the insertion of fiberscope into nose till completion of intubation.

      To assess the Intubation response to tracheal intubation as judged by coughing score and grimace score .

       To assess the Safety profile by observing hemodynamic changes such as heart rate, SBP, DBP incidence of desaturation  pre, intra and post intubation.

       To assess patient’s satisfaction by post-operative evaluation of recall of event and pain during awake fiberoptic intubation by visual analogue scale.

       Complications during procedure if any

   All the patients will be kept NBM at least for 6 hours. Tab. Ranitidine (150mg) will be given night before the surgery.

      After thorough pre-anesthetic evaluation,  patients falling in the inclusion criteria will be selected. Procedure, their role, assessment method all will be explained (patient information sheet) and an informed written consent will be taken.

     Patient will be explained about the visual analogue scale about the severity of pain on horizontal line and it will be assessed post operatively after 24 hour.

Premedication;

    Inj. Glycopyrrolate 0.2mg IV

   Inj. Ondansetron 4mg IV

 

Induction:

Patient preparation :

   Baseline vitals of every patients will be noted.

     Nasal patency confirmed & 2-3 drops of 0.1% xylometazoline will be inserted in both nostrils.

     Lignocaine up to maximum dose of 5mg/kg will be used to topicalize the airway of patient.

    Nebulization with 2% Lignocaine will be done.

   2-3 puffs of 10% lignocaine sprayed on oropharynx and base of tongue

     The superior laryngeal nerves blocked bilaterally  with 2ml of 2% lignocaine & recurrent laryngeal nerve blocked by transtracheal approach with 2ml 2% lignocaine.

     All the patients will be given Inj. Dexmedetomidine 1mcg/kg in 100 ml normal saline bolus over 10 minutes followed by 0.5mcg/kg/hour infusion till completion of fiberoptic intubation.

  Grouping of Patients:

  The study population will be randomly allocated into two groups  of patients each, using envelope method.

        Group A - In this group after giving bolus of Dexmedetomidine Patient will receive Inj. Ketamine 15 mg as a bolus of 5 ml followed Inj. Ketamine 20mg/hour infusion by syringe infusion pump till completion of intubation.

    Group   B  -   In this group  after giving bolus of Dexmedetomidine Patient will receive normal saline as a bolus of 5 ml followed normal saline  infusion by syringe infusion pump till completion of intubation.

      Ramsay sedation scale (RSS) will be assessed after the loading dose of Dexmedetomidine+ ketamine in group A and Dexmedetomidine in group B.

       After confirming  RSS ≥2 ,  fiberoptic bronchoscopy ( using adult fiberoptic bronchoscope) will be done by me after a learning curve of 10 cases.

       While preparing the equipment patient is adequately oxygenated by means of mask ventilation. Lubricate the endotracheal tube & then thread it over the fiberoptic scope.

      For Nasal approach length of the scope to be inserted through nose to visualize epiglottis is predicted by measuring distance from ala of nose to tragus.

     Check to ensure that the fiberscope is flexible and provides a focused view, apply an antifogging agent to the tip of the scope and then connect the oxygen source to the fiberscope.

      Attachment of suction canula to suction port of fiberscope and camera to eyepiece of scope will be checked.

      The Scope is advanced from the nose to the larynx, from the larynx trachea is entered to the subglottic area.

     Once the vocal cords are passed, the scope is slightly flexed downwards to follow the curve to the carina,

   After visualizing carina , loaded endotracheal tube  Polyvinylchloride(PVC)  endotracheal tube will be slided over the bronchoscope to the trachea and tube is positioned 2-3 cm above the carina, the cuff will be inflated and scope is withdrawn.  

      Placement of endotracheal tube is confirmed by direct vision, recording end tidal carbon dioxide and chest auscultation and after checking air entry bilaterally equal,  tube is fixed.

      After the confirmation of intubation study drug will be discontinued and Subsequently general anesthesia will be  administered as per routine protocol .

      The induction of anaesthesia will be done by:

   Inj. Propofol 2mg/kg IV

   Inj. Vecuronium 0.1 mg/kg IV

Maintenance of anaesthesia  with Oxygen, Nitrous oxide, along with Sevoflurane. Muscle relaxation is maintained by Vecuronium 0.02mg/kg iv as an when required.

After completion of surgery reversal is given:

Inj. Neostigmine 0.05mg/kg

           Inj. Glycopyrrolate 0.01mg/kg.

  Monitoring:

   SEDATION: Ramsay  sedation scale will be assessed just after the completion of loading dose of drug in both group. As follows 

      RAMSAY SEDATION SCALE

SCORE

RESPONSE

1

Anxious or restless or both

2

Cooperative, oriented and tranquil

3

Responding to commands only

4

Brisk response to stimulus (light glabellar tap or loud auditory stimuli)

5

Sluggish response to stimulus

6

No response to stimulus


2.    INTUBATION RESPONSE: by coughing score and patient tolerance.

 

        Coughing:

Score 1= no cough.

Score 2=  slight cough (no more than 2 cough in sequence).

Score 3=  moderate cough (3-5 cough in sequence).

Score 4=  severe cough (more than 5 cough in sequence)

       Patient tolerance will assessed by facial grimace score:

     Score 1=  Mild grimace.

   Score 2=  Moderate grimace.

   Score 3=  Severe grimace 

  HAEMODYNAEMIC STABILITY: by monitoring vital parameters throughout the procedure.  

   Post-operative monitoring: At the 24 h postoperative follow-up, the patient will be assessed for satisfaction in terms of recall and pain during AFOI. It is assessed by using 10 cm visual analogue scale.

Proposed Advantages of the study-   Awake fiberoptic intubation is an essential skill in the management of an airway for anaesthesiologist. During awake fiberoptic intubation for better patient cooperation we require better sedation. Dexmedetomidine is well known drug for such procedure but sometimes it can causes bradycardia and hypotension which can be prevented by using  ketamine along with it so, The study will provide an idea about a sedative drug combination suitable for gaining better patient cooperation during awake nasal fibreoptic tracheal intubation. 





 
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