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CTRI Number  CTRI/2025/07/091092 [Registered on: 17/07/2025] Trial Registered Prospectively
Last Modified On: 16/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing Two Medications (Dexmedetomidine and Clonidine)Given as Mist to see Which One is Better Controls Heart rate and blood pressure during Laryngoscopy and Tracheal Intubation on patients undergoing General anaesthesia procedure  
Scientific Title of Study   Evaluating The Efficacy Of Nebulised Dexmedetomidine Vs Clonidine to Attenuate Hemodynamic Response During Laryngoscopy and Tracheal Intubation Under General Anaesthesia-A Prospective Randomised double blinded clinical study  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SYLVIA N 
Designation  Postgraduate  
Affiliation  Esic Medical college and hospital  
Address  B-21/135V ,76 ,Vaigai street ,Nedunchalai nagar, Salem ,Tamilnadu 636005
Department of Anaesthesiology B block ,1st floor,Esic Medical College and Hospital,K.K.Nagar, Chennai 600078
Chennai
TAMIL NADU
636005
India 
Phone  7299130329  
Fax    
Email  sylvian2626@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nataraj M S 
Designation  Head of the department  
Affiliation  ESIC Medical College and Hospital  
Address  Department of Anaesthesiology B block ,1st floor,Esic Medical College and Hospital,K.K.Nagar, Chennai 600078

Chennai
TAMIL NADU
600078
India 
Phone  9886571461  
Fax    
Email  natarajms23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sylvia  
Designation  Postgraduate  
Affiliation  ESIC Medical College and Hospital  
Address  Department of Anaesthesiology B block ,1st floor,Esic Medical College and Hospital,K.K.Nagar, Chennai 600078

Chennai
TAMIL NADU
600078
India 
Phone  7299130329  
Fax    
Email  Sylvian2626@gmail.com  
 
Source of Monetary or Material Support  
Esic Medical college and hospital  
 
Primary Sponsor  
Name  Esic Medical college and hospital  
Address  Department of Anaesthesiology B block ,1st floor,Esic Medical College and Hospital,K.K.Nagar, Chennai 600078 
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 SYLVIA N  Esic Medical college and hospital   Department of Anaesthesiology B block ,1st floor,Esic Medical College and Hospital,K.K.Nagar, Chennai 600078
Chennai
TAMIL NADU 
7299130329

sylvian2626@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Esic Medical College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H663||Other chronic suppurative otitis media,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nebulised clonidine   Clonidine 2mcg/Kg diluted in 4ml of 0.9% normal saline for 10 mins 
Intervention  Nebulised Dexmedetomidine   Dexmedetomidine 2mcg/Kg diluted in 4ml of 0.9% normal saline for 10 Mins  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patient with written informed consent
Either gender
Undergoing general anaesthesia procedure
ASA 1 and 2 
 
ExclusionCriteria 
Details  Patient refusal
Patient allergic to drugs
Emergency surgeries
BMI more than 35
Pregnancy
Patient on beta-blockers ARB ACE Inhibitors
Anticipated difficult airway
Intubation duration more than one minute  
 
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 evaluate the hemodynamic response of dexmedetomidine Vs clonidine nebulization during laryngoscopy and tracheal intubation under general anaesthesia   1 min,3 minutes, 5 minutes, 8 minutes, 11 minutes, 15 minutes post intubation  
 
Secondary Outcome  
Outcome  TimePoints 
To Evaluate the post operative sore throat
To assess the occurrence of bradycardia & hypotension  
Postoperative sore throat 2 hours after extubation
Bradycardia, hypotension during & after nebulisation  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/08/2025 
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 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   Patients will be randomly assigned to one of two groups (A and B) using computer-generated random numbers. Group A will receive nebulisation with dexmedetomidine 2 mcg/kg in 4 ml of 0.9% normal saline. Group B will receive nebulisation with clonidine 2 mcg/kg in 4 ml of 0.9% normal saline. A qualified anaesthesiologist with 1 year of experience, uninvolved in the study, will prepare the study drugs. Allocation will be concealed using a sequential numbering system with sealed opaque envelopes, which will be opened in the pre-operative room. After allocation, baseline systolic, diastolic, and mean blood pressure, heart rate, and peripheral oxygen saturation (SpO2) will be recorded in the pre-anaesthetic room. Monitoring will continue throughout the nebulisation procedure, and vital signs will be recorded. Nebulisation will be performed using a wall-attached oxygen drive source 20 minutes before induction until the chamber empties. Any side effects like bradycardia (defined as heart rate less than 25 % of the baseline or <50/min) and hypotension (defined as systolic blood pressure less than 25 % of the baseline or <90 mm Hg) will be recorded during and after the nebulisation.

Patients will be transferred to the operating room, where standard ASA monitors will be attached. Following preoxygenation with 100% oxygen, fentanyl 2 mcg/kg will be administered intravenously. Anaesthesia will be induced with propofol titrated to loss of verbal response. Atracurium 0.5 mg/kg will be used for muscle relaxation. Direct laryngoscopy and endotracheal intubation will be performed using an appropriately sized laryngoscope and endotracheal tube. Intubation will be performed by a qualified anaesthesiologist with one year of experience. Cormack-Lehmann (CL) grading of laryngoscopy and duration of intubation will be recorded. Controlled ventilation will then be established and titrated to maintain end-tidal carbon dioxide at 30-40 mmHg. Systolic, diastolic, and mean blood pressure, heart rate, and SpO2 will be recorded during intubation and at 1, 3, 5, 8, 11, and 15-minutes post-intubation. If blood pressure increases by more than 25% from baseline, or if heart rate increases by more than 25% from baseline, esmolol 0.5 mg/kg will be administered intravenously to attenuate the hemodynamic response. Depth of anaesthesia will be maintained with sevoflurane to a minimal alveolar concentration (MAC) of 1. Intraoperative analgesics, fluids, blood products and vasopressors will be administered at the discretion of the consultant anaesthesiologist. Thirty minutes before the end of surgery, ondansetron 0.1 mg/kg will be administered intravenously. All patients will be reversed with neostigmine 0.05 mg/kg and glycopyrrolate 0.02mg/kg and extubated after meeting extubation criteria.

 
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