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CTRI Number  CTRI/2024/02/063320 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 27/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the effect of a drug named Dexmedetomidine which is administered through nose before insertion of tube through windpipe for management of anaesthesia 
Scientific Title of Study   The effect of Intranasal Dexmedetomidine on Hemodynamic responses during Double Lumen Tube insertion- A Randomized Controlled Trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Roys Prathima G 
Designation  PG Registrar 
Affiliation  Christian Medical College  
Address  Department of Anaesthesiology, Christian Medical College, Vellore, Tamilnadu, India

Vellore
TAMIL NADU
632004
India 
Phone  8660889336  
Fax    
Email  roysprathima34@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Balaji Kuppuswamy 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department of Anaesthesiology, Christian Medical College, Vellore, Tamilnadu, India

Vellore
TAMIL NADU
632004
India 
Phone  7406777127  
Fax    
Email  balooswamy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Balaji Kuppuswamy 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department of Anaesthesiology, Christian Medical College, Vellore, Tamilnadu, India


TAMIL NADU
632004
India 
Phone  7406777127  
Fax    
Email  balooswamy@gmail.com  
 
Source of Monetary or Material Support  
Fluid Research Grant, Christian Medical College, Vellore- 632004 Tamilnadu, India 
 
Primary Sponsor  
Name  Roys Prathima G 
Address  Dr Roys Prathima G, Department of Anaesthesiology, Christian Medical College, Vellore- 632004, Tamilnadu, India 
Type of Sponsor  Other [Self] 
 
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 Roys Prathima G  Christian Medical College   Department of Anaesthesiology, Christian Medical College
Vellore
TAMIL NADU 
8660889336

roysprathima34@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insstitutional Review Board and Ethics Committee of CMC Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J984||Other disorders of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intranasal Dexmedetomidine group  Intranasal Dexmedetomidine-1mcg/kg administered 45 minutes prior to induction and Hemodynamic responses To Laryngoscopy and Endobronchial intubation with DLT is observed  
Comparator Agent  Placebo group  Intranasal Normal saline- 2ml administered 45 minutes prior to induction and Hemodynamic Responses to Laryngoscopy and Endobronchial intubation with DLT is observed 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients undergoing elective lung surgery including pulmonary lobectomy, pneumonectomy, metastasectomy, decortication, etc who require Left sided DLT placement
ASA Physical status I to III
 
 
ExclusionCriteria 
Details  1. Patients with difficult airway
2. Surgeries requiring Right sided Double Lumen Tube insertion
3. Uncontrolled hypertensives
4. Heart disease with ejection fraction less than 40%
5. Body mass index more than 35 kg/ m2
6. History suggestive of sensitivity to drugs used during the study
7. Patients with bradycardia (heart rate < 50 beats per minute) or any heart block
8. Nasal pathology
9. History of reactive airway disease
10. Hepatic or Renal impairment
11. Pregnancy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the Hemodynamic responses between Dexmedetomidine and Placebo given in addition to drugs used in our current standard of care during laryngoscopy and DLT insertion  1 hour 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the requirement of additional anaesthetic drugs ( fentanyl, propofol) in order to maintain the hemodynamics within 20% of baseline values during Laryngoscopy and DLT insertion
2. To assess the incidence of hypotension and bradycardia during drug administration and during laryngoscopy and DLT insertion
3. To assess the intraoperative requirement of rescue medication ( phenylephrine, ephedrine) to treat the hypotension and bradycardia 
1 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   Phase 3 
Date of First Enrollment (India)   07/03/2024 
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="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Tracheal intubation and laryngoscopy may cause sympathetic stimulation, which can cause tachycardia and hypertension. To abolish the pressor response to laryngoscopy and endotracheal intubation, many medication combinations have been tried with varying degrees of efficacy.
The purpose of this study is to evaluate the effect of Intranasal Dexmedetomidine on hemodynamic responses to laryngoscopy and endobronchial intubation with a double lumen tube. Patients coming for elective lung surgery meeting the required inclusion criteria will be enrolled for this study. Information about the study will be conveyed and consent obtained in the preoperative period.
     Patients will be divided into two groups by computer-generated block randomization: Group A will receive Intranasal dexmedetomidine (1mcg/kg) diluted in 2 ml syringe and Group B will receive placebo (0.9 % saline) in 2 ml syringe in equal volume into both nostrils.
     Patients in pre induction room, after connecting to standard ASA monitors – ECG, Pulse Oximetry, Blood Pressure, study drug will be administered belonging to either Group A (Dexmedetomidine) or Group B (Placebo). 45 minutes after administration of the study drug, patients will be wheeled into Operating Theatre. After connecting standard ASA monitors, all patients will be induced with IV propofol upto 2mg/kg, fentanyl 1 mcg/kg, lignocaine 1.5mg/kg and vecuronium 0.1 mg/kg, in accordance with the current standard of care given in our hospital. Anaesthesia will be maintained with sevoflurane to get a MAC of 1 until tracheal intubation. After 3 minutes of mask ventilation, laryngoscopy and DLT insertion will be performed by an anaesthesiologist at the level of final year MD registrar or above. If the first attempt by the registrar is unsuccessful, subsequent attempts will be done by the senior anaesthesiologist posted on the list.
    Episodes of hypotension will be treated with a bolus of Ephedrine hydrochloride 3-6mg or Phenylephrine 25-50 mcg. Bradycardia will be treated with 0.3-0.6 mg atropine bolus. Any hypertension or tachycardia will be treated with additional doses of propofol and/or fentanyl. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR), will be recorded at baseline and regular intervals. All incidences of hypotension and bradycardia will be documented and the number of doses of rescue medication administered will be noted. The total laryngoscopy and DLT insertion time, total fiberoptic bronchoscopy time and total isolation time will be noted.

 
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