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CTRI Number  CTRI/2025/11/096768 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 01/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of different doses of drugs in nebulised route to reduce airway responses during general anaesthesia technique . 
Scientific Title of Study   Comparison of nebulised Fentanyl and different doses of nebulised Dexmedetomidine in attenuation of hemodynamic stress response to laryngoscopy and endotracheal intubation in patients undergoing nasal surgery : A randomised double blind 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  DR PRIYA N  
Designation  JUNIOR RESIDENT  
Affiliation  KMC-RI Hubli  
Address  Karnataka medical college and research institute, Department of Anaesthesiology, room no. 206, IP division, Vidyanagar,Hubli

Dharwad
KARNATAKA
580021
India 
Phone  8277253693  
Fax    
Email  priyaraani264@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR DHARMESH A LADHAD 
Designation  ASSISTANT PROFESSOR  
Affiliation  KMC-RI Hubli  
Address  Karnataka institute of medical sciences and research institute . Department of Anaesthesiology, room no.206 , IPdivision, Vidyanagar,Hubli

Dharwad
KARNATAKA
580021
India 
Phone  9482097491  
Fax    
Email  ladhaddharmesh@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DR PRIYA N  
Designation  JUNIOR RESIDENT  
Affiliation  KMC-RI Hubli  
Address  Karnataka medical college and research institute . Department of Anesthesiology, room no.206 , IP division, Vidyanagar, Hubli

Dharwad
KARNATAKA
580021
India 
Phone  8277253693  
Fax    
Email  priyaraani264@gmail.com  
 
Source of Monetary or Material Support  
Karnataka medical college and research institute . Department of Anesthesiology, room no.206 , IP division, Vidyanagar, Hubli Pin code 580021 Dharwad district Karnataka state India  
 
Primary Sponsor  
Name  Karnataka medical college and research institute Vidyanagar Hubli  
Address  Karnataka medical college and research institute . Department of Anesthesiology, room no.206 , IP division, Vidyanagar, Hubli  
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 PRIYA N  Karnataka medical college and research institute   Karnataka medical college and research institute . Department of Anesthesiology, room no.206 , IP division, Vidyanagar, Hubli
Dharwad
KARNATAKA 
8277253693

priyaraani264@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Karnataka medical college and research institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J342||Deviated nasal septum, (2) ICD-10 Condition: 8||Other Procedures, (3) ICD-10 Condition: H040||Dacryoadenitis, (4) ICD-10 Condition: J324||Chronic pansinusitis, (5) ICD-10 Condition: J330||Polyp of nasal cavity, (6) ICD-10 Condition: J343||Hypertrophy of nasal turbinates, (7) ICD-10 Condition: J339||Nasal polyp, unspecified, (8) ICD-10 Condition: J320||Chronic maxillary sinusitis, (9) ICD-10 Condition: J324||Chronic pansinusitis, (10) ICD-10 Condition: J341||Cyst and mucocele of nose and nasal sinus, (11) ICD-10 Condition: J393||Upper respiratory tract hypersensitivity reaction, site unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparison of different doses of drugs in nebulised form .  IN this study we compare different drug dosages i,e nebulised fentanyl 1 mcg/kg , nebulised dexmedetomidine 1mcg/kg and nebulised dexmedetomidine 1.5 mcg/kg in patients undergoing nasal surgeries to reduce the stress responses to laryngoscopy and endotracheal intubation . 
Intervention  Reducing stress response to laryngoscopy and endotracheal intubation   To compare different doses of nebulized dexmedetomidine and nebulized fentanyl in attenuation of hemodynamic stress response to laryngoscopy and endotracheal intubation in patients undergoing nasal surgeries.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  AMERICAN SOCIETY OF ANAESTHESIOLOGISTS [ASA]physical status classification I and II
Patients undergoing elective nasal surgeries under general anaesthesia
Patients giving valid informed written consent  
 
ExclusionCriteria 
Details  Patients with neurological disorders , uncontrolled hypertension, uncontrolled Type 2 Diabetes mellitus,Ischemic heart disease, Chronic obstructive pulmonary disease, Bronchial asthma, Bleeding disorders, Psychiatric illness and nasal trauma .
Patients with history of allergy to opiods and local anaesthetic agents and dexmedetomidine .
Pregnant , lactating mothers.
Morbidly obese patients BMI more than 40 kg / m² 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of nebulised dexmedetomidine 1 mcg/kg ,1.5 mcg/kg and fentanyl 1 mcg/kg in attenuating hemodynamic stress response to laryngoscopy and endotracheal intubation in terms of changes in systolic blood pressure (SBP),Diastolic blood pressure (DBP),mean blood pressure (MBP)and heart rate (HR) in patients undergoing elective nasal surgeries.   Nebulisation will be given 10min before shifting to operation theatre.  
 
Secondary Outcome  
Outcome  TimePoints 
To assess postoperative pain using Visual Analog Scale immediately after extubation i.e 0hrand 1hr,3hr,6hr,12hr post surgery and extubation   0hr , 1hr, 3hr, 6hr, 12hr post surgery and extubation. 
To assess postoperative Ramsay sedation score immediately after extubation i.e 0hr and 1hr, 3hr,6hr, 12hr post surgery and extubation.   0hr, 1hr, 3hr, 6hr, 12hr post surgery and extubation.  
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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/ Phase 3 
Date of First Enrollment (India)   12/11/2025 
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   A prospective, randomized controlled trial will be conducted on 90 patients of ASA I and II undergoing elective nasal surgeries under general anaesthesia, between age group of 18-65 years in KIMS Hubballi. Patients will be enrolled for the study and randomly allocated into 3 groups as per computer generated table.

GROUP A (n=30): Patients who will receive nebulisation dexmedetomidine 1 ug/kg 10min before induction 

GROUP B (n=30):Patients who will receive nebulisation dexmedetomidine 1.5 ug/kg 10min before induction .

GROUP C (n=30):Patients who will receive nebulization fentanyl 1ug/kg 10min before induction .

Pre-operative data will be collected prospectively for all patients undergoing nasal surgeries requiring general anaesthesia in our institution. All patients who meet the inclusion criteria, will undergo pre-anaesthetic evaluation a day prior to surgery. Height and weight of the patient will be noted. Informed valid written consent will be taken from all patients. Patients will be kept nil by mouth for solid food for 8 hours and clear liquids for 2 hours before surgery. Patients will be shifted to preoperative room on the day of surgery . Prenebulisation monitors will be connected HR ,SBP,DBP,MAP will be recorded . Preoperative anxiety will be assesed using APAIS in all the 3 groups . Patients according to the the group allocated will recieve nebulisation. The nebulization solution will be prepared by anaesthsiology resident not involved in making observations and the observer anaesthesiologist will be blinded. 10 min after the nebulisation anxiety and sedation will be assesed using RSS. Patients will be wheeled into the operation theatre and monitors will be attached (electrocardiography, non-invasive blood pressure, Oxygen saturation and heart rate) and baseline values of HR, SBP, DBP, MAP and SPO2 will be recorded.18 G IV cannula will be secured in the non-dominant upper limb of patient and Ringer lactate infusion will be started and patient will be briefed about the procedures to be performed. Patients premedicated with inj. glycopyrrolate 0.004mg/kg inj. midazolam 0.05 mg/kg and inj. Fentanyl 2mcg/kg i.v. After 3 minutes of preoxygenation, anaesthesia will be induced with Inj. Propofol 2 mg/kg i.v. and vecuronium bromide 0.1mg/kg will be given intravenously. Endotracheal intubation will be carried out after 3 minutes, with appropriate sized cuffed endotracheal tube (ETT) using Macintosh laryngoscope. Anaesthesia will be maintained with oxygen and nitrous oxide (50:50), intermittent vecuronium and sevoflurane. Minute ventilation will be adjusted to maintain normocapnia (etCO2 between 35 and 40 mmHg). During procedure HR, SBP , DBP , MAP will be recorded at 1 , 5, 10 min post intubation . All patients will receive infilteration on the nasal mucosa with 2% Lignocaine with adrenaline by the operating surgeon 15 minutes post intubation as is usually administered by the surgeons for nasal surgeries to achieve reduced blood loss and also analgesia.

At the end of the surgery, the inhalational anaesthetics used for maintenance of anaesthesia will be stopped . The HR, SBP, DBP and MAP values will be recorded. The muscle relaxation will be reversed with injection neostigmine 0.05mg/kg IV and glycopyrrolate 0.01 mg/kg .

Occurrence of any adverse events will be recorded. Hypotension is defined as fall in SBP<80 mmHg and bradycardia is defined as fall in HR<50 beats per minute. Hemodynamic fluctuations will be managed accordingly. Ondansetron (4 mg IV) will be administered on complaint of nausea and vomiting.

All patients will be administered inj paracetomol 20mg/kg post operatively TID for maintaining adequate analgesia .Patients will be assesed for post operative pain using VAS ( Visual Analog Scale) and RSS at 0,1, 3 , 6 , 12 hrs after the surgery.Any adverse events will be recorded and treated accordingly. 
 
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