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CTRI Number  CTRI/2025/10/095825 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 04/12/2025
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   Study comparing two types of pre surgery nebulization one with dexmedetomidine and the other with a combination of ketamine and dexmedetomidine to find which is better to prevent sore throat after laparoscopic surgery in adults 
Scientific Title of Study   Comparison of Nebulization with Dexmedetomidine versus Ketamine-Dexmedetomidine combination for Post-Operative Sore Throat in adult patients undergoing laparoscopic surgery - A Randomised parallel arm 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  Dr Nikhil Badetiya 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences Bhopal 
Address  All India Institute of Medical Sciences Bhopal,Department of Anesthesiology,Saket Nagar,462020 Bhopal Madhya Pradesh,462020,INDIA

Bhopal
MADHYA PRADESH
462020
India 
Phone  8740990681  
Fax    
Email  nikhilbadetiya@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashutosh Kaushal 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences Bhopal 
Address  All India Institute of Medical Sciences Bhopal,Department of Anesthesiology,Saket Nagar,462020 Bhopal Madhya Pradesh,462020,INDIA

Bhopal
MADHYA PRADESH
462020
India 
Phone  8765515521  
Fax    
Email  ashutosh.anaesth@aiimsbhopal.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Ashutosh Kaushal 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences Bhopal 
Address  All India Institute of Medical Sciences Bhopal,Department of Anesthesiology,Saket Nagar,462020 Bhopal Madhya Pradesh,462020,INDIA

Bhopal
MADHYA PRADESH
462020
India 
Phone  8765515521  
Fax    
Email  ashutosh.anaesth@aiimsbhopal.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Bhopal(Non funded) 
 
Primary Sponsor  
Name  Dr Ashutosh Kaushal 
Address  All India Institute of Medical Sciences Bhopal,Department of Anesthesiology,Saket Nagar,Bhopal,Madhya Pradesh 462020 
Type of Sponsor  Other [Guide(Additional Professor)] 
 
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 Ashutosh Kaushal  All Institute of Medical Sciences Bhopal  All Institute of Medical Sciences Bhopal,Department of Anesthesiology,Saket Nagar,Bhopal,Madhya Pradesh,462020
Bhopal
MADHYA PRADESH 
8765515521

ashutosh.anaesth@aiimsbhopal.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS,Bhopal Institutional Human Ethics Committee-Student Research(IHEC-SR)  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
Modification(s)  
Type  Name  Details 
Comparator Agent  Group 1: Nebulized Dexmedetomidine 1mcg/kg diluted in 4 ml of normal saline  On the day of surgery, Patients will be nebulized according to their assigned group as follows 40 Patients will be nebulized with dexmedetomidine 1 mcg/kg diluted in 4 ml of normal saline over 15 minutes. 
Intervention  Group 2:Nebulized Dexmedetomidine 1mcg/kg and Ketamine 0.5mg/kg diluted in 4 ml of normal saline.  On the day of surgery, Patients will be nebulized according to their assigned group as follows 40 Patients will be nebulized with a combination of dexmedetomidine 1mcg/kg and ketamine 0.5mg/kg diluted in 4 ml of normal saline over 15 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with American Society of Anesthesiologist (ASA) physical status grading I & II. 
 
ExclusionCriteria 
Details  1. Non consenting patients.
2. Allergy to dexmedetomidine or ketamine.
3.Current upper respiratory tract infections, pre-existing sore throat and/or hoarseness.
4.Patients using steroids or nonsteroidal anti-inflammatory drugs.
5.Patients with chronic obstructive pulmonary disease, asthma.
6.Pregnant patients.
7.Any history of difficult intubation, loose teeth.
8.Difficult intubation requiring more than one attempt.
9.Already intubated patients.
10.Patients not extubated at the end of surgery.
11.Patients with sinus bradycardia, atrioventricular block, cardiac disease. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of Postopertive sore throat (POST) between both the groups.   10 mins,6hrs,12hrs and 24hrs after extubation. 
 
Secondary Outcome  
Outcome  TimePoints 
To estimate and compare effect of nebulisation with dexmedetomidine and ketaminedexmedetomidine on heart rate (HR), systolic blood pressure (SBP), diastolic blood
pressure (DBP)and mean arterial pressure (MAP) at defined time point. 
0 minute at induction,0 minute at intubation, 1 minute
and 5 minutes after intubation 
To estimate and compare effect of nebulisation with dexmedetomidine and ketamine-dexmedetomidine on patient sedation using Ramsay sedation score.  10 minutes,1hr,6hrs after extubation. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/12/2025 
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  

Postoperative sore throat is a common complication following general endotracheal anaesthesia affecting patient’s postoperative comfort and satisfaction

Several pharmacological agents like Dexamethasone Ketamine Dexmedetomidine Magnesium sulphate etc have been tried through nebulization route have been studied with promising results Although Dexmedetomidine nubulisation and Dexmedetomidine in combination with Ketamine nebulisation are routinely used in Anaesthesiology practice there is literature deficit regarding there comparison for prevention of POST This study intends to compare efficacy of Dexmedetomidine nebulisation alone or Dexmedetomidine in combination with Ketamine nebulisation for prevention of POST in adult patients undergoing laparoscopic surgery

80 Patients will be randomized by computer generated randomization number into two groups D and DK with equal number of participants

Allocation concealment will be ensured through the use of sealed opaque envelopes

The patient and the investigator collecting the data will be blinded to the study intervention groups

The following baseline demographic and clinical characteristics will be recorded for all patients in preoperative area before shifting the patient to operating room age sex ASA physical status non invasive Blood Pressure Heart Rate SPO2 as baseline parameter Standard ASA provided NPO guideline will be followed for the study

All patients will undergo a thorough preoperative evaluation one day before surgery A detailed explanation of the study will be provided to each participant and written informed consent will be obtained Adequate fasting status will be confirmed before surgery and all patients will receive standard anti-aspiration prophylaxis

On the day of surgery Patients will be nebulized according to their assigned group as follows

Group D 40 Patients will be nebulized with dexmedetomidine 1 mcg per kg diluted in 4 ml of normal saline over 15 minutes

Group DK 40 Patients will be nebulized with a combination of dexmedetomidine 1mcg per kg and ketamine 0.5mg per kg diluted in 4 ml of normal saline over 15 minutes

In both groups standard anaesthesia management will be done as mentioned below

Upon arrival in the operating room standard American Society of Anesthesiologists ASA monitors will be attached including noninvasive blood pressure pulse oximetry electrocardiography

The patents will be preoxygenated with 100 percentage oxygen Induction will be achieved with intravenous fentanyl 1to2 mcg per kg and propofol  2mg per kg  titrated to the effect of  loss of verbal response and vecuronium 0.1 mg per kg and after securing airway with endotracheal intubation anaesthesia will be maintained with Isoflurane 0.5 to 1 MAC  and O2  and N2O ratio is 40 and 60 ratio Smooth laryngoscopy and intubation lasted less than 15 sec will be performed by same well experienced anaesthesiologist to avoid interobserver bias

Normocapnia will be maintained with controlled mechanical ventilation with endtidal carbondioxide tension values ranging from 30 to 35 mmHg  Euvolemia will be maintained with crystalloid infusion Normothermia will be maintained throughout the surgery with forced air warming device and infusion of warm fluids  Antiemetic in the form of Ondansetron 4mg IV will be given 30 min before end of surgery Gentle extubation of the patient will be done after reversal of neuromuscular blocking agent after completion of the surgery

The following parameters will be recorded in the study CormackLehane grading during laryngoscopy ETT cuff pressure using a cuff manometer and hemodynamic parameters systolic diastolic and mean arterial pressures heart rate and oxygen saturation and sedation at predefined time points during induction laryngoscopy and intubation 1 and 5minutes postintubation and following pneumoperitoneum creation Airway pressure will be noted and keep less than 25 cm H2O after intubation and following intraabdominal gas insufflation The ETT intracuff pressure will be remeasured and documented just before extubation

In the postoperative period sore throat will be assessed and graded using 4 Point scale as per Harding and McVey  at 10 minutes 6 hours 12 hours and 24 hours following extubation Sore throat will be treated according to standard POST treatment protocol Additionally hemodynamic parameters blood pressure heart rate and oxygen saturation will be recorded at extubation at 10 minute and 1 hour 6 hours 12 hours and 24 hours postextubation  Sedation using Ramsay sedation score  will be assessed at 15 minutes after nebulisation 10 minute 1 hour  6 hours after extubation.

 

 

 

 
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