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CTRI Number  CTRI/2024/04/065959 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 17/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Other 
Public Title of Study   Preoperative Dexmedetomidine Nebulization Vs Lignocaine and normal saline Nebulization to Blunt Stress Response To Laryngoscopy And Intubation  
Scientific Title of Study   A Comparative Study To Evaluate The Effects Of Preoperative Dexmedetomidine Nebulization Vs Lignocaine and normal saline Nebulization On The Hemodynamic Response To Laryngoscopy And Intubation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alpa Patel  
Designation  Professor 
Affiliation  Pramukh swami medical college 
Address  Department of anaesthesiology Shree krishna hospital Pramukh swami medical college karamsad Anand Gujarat 388325 India

Anand
GUJARAT
388325
India 
Phone  9825084282  
Fax    
Email  alpamp@charutarhealth.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Hardikkumar Manilal Makwana 
Designation  Resident Anesthesiologist  
Affiliation  Pramukh swami medical college 
Address  Department of anaesthesiology Shree krishna hospital Pramukh swami medical college karamsad Anand Gujarat 388325 India

Anand
GUJARAT
383315
India 
Phone  8758922773  
Fax    
Email  hardikmakwana19021997@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hardikkumar Manilal Makwana 
Designation  Resident Anesthesiologist  
Affiliation  Pramukh swami medical college 
Address  Department of anaesthesiology Shree krishna hospital Pramukh swami medical college karamsad Anand Gujarat 388325 India

Anand
GUJARAT
383315
India 
Phone  8758922773  
Fax    
Email  hardikmakwana19021997@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology Shree krishna hospital Pramukh swami medical college karamsad Anand Gujarat 388325 India 
 
Primary Sponsor  
Name  Shri Krishna Hospital  
Address  Department of anaesthesiology Shree krishna hospital Pramukh swami medical college karamsad Anand Gujarat 388325 India  
Type of Sponsor  Private 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 Hardik Makwana  Pramukh Swami medical college,shree Krishna Hospital,Karamsad,Anand  Department of anesthesiology,Surgical operation theatre comple,karamsad
Anand
GUJARAT 		 8758922773

hardikmakwana19021997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaikaka University, Karamsad, Anand, Gujarat- 388325  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexmedetomidine vs Lignocaine and normal saline  To compare Effects on the hemodynamic response to laryngoscopy and intubation with preoperative Dexmedetomidine nebulization vs Lignocaine and normal saline nebulization 
Intervention  laryngoscopy and intubation  To see Effect on the hemodynamic response to laryngoscopy and intubation with preoperative Dexmedetomidine nebulization vs Lignocaine and normal saline nebulization 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient undergoing elective surgeries requiring general anesthesia and tracheal intubation and Belonging to ASA grade 1 2 and 3  
 
ExclusionCriteria 
Details  Patients unwilling to participate
Patients with renal hepatic cardiovascular or respiratory diseases belonging to ASA grade 4 or more
Pregnant and lactating women
Patient with history of allergy to dexmedetomidine and lignocaine
Patient with sore throat dry cough local factors in nose and mouth pre operatively 
 
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 
To prevent hemodynamic stress response to laryngoscopy and intubation   At the time of incision at 0 minute and post extubation 
 
Secondary Outcome  
Outcome  TimePoints 
To see if lesser amount of propofol is required  During laryngoscopy and intubation 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 2 
Date of First Enrollment (India)   29/04/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Patients undergoing elective surgery requiring laryngoscopy and tracheal intubation will be recruited in this study. Pre -anesthetic check-up will be carried out in all patients. On arrival to operation  theatre, Standard intraoperative monitoring- electrocardiogram, pulse oximetry and  non-invasive blood pressure will be attached and baseline vitals will be noted. Participants will be allotted in to two groups.Group A will receive pre-operative nebulization with Dexmedetomidine at a dose of 0.75 mcg/kg in 2 ml of 0.9% saline,20 min before induction of anesthesia and Group B will receive pre-operative nebulization with Lignocaine 2% 2ml in 2 ml of 0.9% saline, 20 min before induction of anesthesia .The drugs for nebulization (dexmedetomidine or lignocaine) will be prepared and administered by an independent investigator in the preoperative holding area. Hemodynamic parameters such as Heart Rate, Systolic & Diastolic BP, pulse oximetry will be recorded before nebulization. Nebulization will be carried out with an electrical compressor nebulizer, capable of creating a fine mist until the entire volume is dispersed–usually within 15–20 min. Pre-oxygenation will be done with 100% O2 for 3 minutes. Hemodynamic parameters such as Heart Rate, Systolic & Diastolic BP, pulse oximetry will be recorded before induction of general anesthesia. After which induction agent as per choice in concentration approved and Hemodynamic parameters will be then recorded every 1 minute till 10 minutes after laryngoscopy. Intubation will be confirmed by EtCO2 and bilaterally equal air entry and then connected to a ventilator for intermittent positive pressure ventilation until completion of surgery. Patients will be kept in the postoperative care unit for an additional 1 hour and discharged to the ward once they met the criteria for discharge (i.e., Aldrete recovery scale). The presence of postoperative sore throat will be noted as present or absent. As per literature, Nebulization Dexmedetomidine has less systemic bioavailability hence incidence of side effects should be reduced, if any side effects happened like clinically relevant hypotension will be defined as decrease in mean arterial pressure 20% or more from base line. In that case inj. crystalloids bolus will be given and if required vasopressor support may be given. Nebulized lidocaine also appears to be well tolerated by patients with minimal side effects including dysphonia, oropharyngeal numbness, and bitter taste 
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