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CTRI Number  CTRI/2025/10/095560 [Registered on: 01/10/2025] Trial Registered Prospectively
Last Modified On: 13/10/2025
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study
Modification(s)  
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing two ways of giving the medicine dexamethasone (by mouth inhalation through a nebulizer vs injection into the vein) to see which better prevents sore throat after spine surgery done in the face-down position. 
Scientific Title of Study   Effect of Preemptive Dexamethasone via nebulization versus intravenous route on Postoperative sore throat after spine surgery in prone position: A Randomised, Double-blinded 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  Syed Rizwanuddin 
Designation  Junior Resident 
Affiliation  AIIMS BHOPAL 
Address  All India Institute of Medical Sciences Department of Anaesthesiology 3rd floor, Hospital Building AIIMS BHOPAL Saket Nagar

Bhopal
MADHYA PRADESH
462020
India 
Phone  8095333672  
Fax    
Email  syedrizwanuddin786@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sunaina Tejpal Karna 
Designation  Professor 
Affiliation  AIIMS Bhopal 
Address  Department of Anesthesiology, 3rd Floor, Trauma Block, Main Hospital Building, Saket Nagar, Bhopal
Emerald Park City, Baghsewaniya
Bhopal
MADHYA PRADESH
462020
India 
Phone  09540946869  
Fax    
Email  drtejpal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sunaina Tejpal Karna 
Designation  Professor 
Affiliation  AIIMS Bhopal 
Address  Department of Anesthesiology, 3rd Floor, Trauma Block, Main Hospital Building, Saket Nagar, Bhopal
Emerald Park City, Baghsewaniya
Bhopal
MADHYA PRADESH
462020
India 
Phone  09540946869  
Fax    
Email  drtejpal@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Bhopal 
 
Primary Sponsor  
Name  Dr Sunaina Tejpal Karna 
Address  Department of Anesthesiology, Third floor, Trauma Block, Hospital Building, AIIMS Bhopal, Saket Nagar, Bhopal, Madhya Pradesh, India. 462020. 
Type of Sponsor  Other [] 
 
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 Sunaina Tejpal Karna  All India Institute of Medical Sciences Bhopal  Department of Anesthesiology, 3rd Floor, Trauma Block, Main Hospital Building, Saket Nagar, Bhopal Emerald Park City, Baghsewaniya
Bhopal
MADHYA PRADESH 
09540946869

drtejpal@gmail.com 
 
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  
Type  Name  Details 
Comparator Agent  Group I- Intravenous Dexamethasone  Upon arrival in the preoperative room, the patients will receive nebulization with a 5 ml solution for 15-20 minutes and intravenous injection of a 5 ml volume clear solution before wheeling into the operating theatre. The intervention will be as per the group allocated. The patients in Group I (Intravenous Dexamethasone) will be Nebulized with 0.9% saline (5ml) and intravenous injection of Dexamethasone 0.2 mg/kg diluted to a total volume of 5 ml with 0.9% saline will be given. 
Intervention  Group N - Nebulization with dexamethasone  Upon arrival in the preoperative room, the patients will receive nebulization with a 5 ml solution for 15-20 minutes and intravenous injection of a 5 ml volume clear solution before wheeling into the operating theatre. The intervention will be as per the group allocated. In Group N , the patients will be nebulized with Dexamethasone 0.2 mg/kg diluted to a total volume of 5 ml with 0.9% saline and also 5ml of 0.9% saline. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists physical status (ASA) I & II
Patients undergoing Spine surgery in the prone position under General anaesthesia with endotracheal intubation with an armoured tube
Providing written informed consent for study participation
 
 
ExclusionCriteria 
Details  Cervical spine surgery
Pregnant or breastfeeding females
Patients already on steroid therapy or having taken steroids in any form 12 hours before surgery
Patients with ongoing sore throat or pain in the throat or asthma or hoarse voice or history of respiratory tract infection or sore throat in the 2 weeks before surgery
Diabetes mellitus
Immunocompromised patients
Impaired renal cardiac or hepatic function
Patient with psychiatric disorders or antipsychotic therapy
Allergy to Dexamethasone
More than three attempts are required for intubation
The patient needs postoperative mechanical ventilation in the intensive care unit
 
 
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 Postoperative sore throat (POST) between both the groups  At 2, 6, 12, and 24 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Grade of POST on a 4-point scale in between both the
groups 
at 2, 6, 12, and 24 hours after surgery 
Incidence of hoarseness of voice, dysphagia, stridor   At 2,6, 12, 24 hours after surgery 
Incidence of postoperative nausea and vomiting at   At 2, 6, 12, 24 hours after surgery 
Quality of recovery with QoR-15 score   At 48 hours and 1 week after surgery 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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   Post Marketing Surveillance 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
All patients fulfilling inclusion and exclusion criteria will be identified the day before surgery and The patient information sheet will be given to the study participants  who will be informed about the study protocol Written informed consent will also be obtained from all the study participants for the conduct of the study  Age gender and body mass index (BMI) will be measured and noted  American Society of Anesthesiologists physical grade and planned surgery will also be noted and We will do computer-based permuted block randomisation using the blockrand R package  A random sequence will be generated with varying block sizes and kept in 160 opaque sealed envelopes It will be prepared and administered by an independent trained anesthesiologist He/she will prepare a nebulisation solution and an intravenous solution with a 5 ml volume The drug dexamethasone will be in the solution based on the group to which the patient is allocated Double blinding will be done An anaesthetist not part of the study will prepare the intervention drugs No one in the anesthesiology team responsible for the patient’s care during and after surgery will know the patient’s group allocation The anaesthetist will assess the outcome data and the patient will be blinded to the group allocation
In the study by Ramamurthy et al comparing intravenous with nebulised dexamethasone the incidence of POST(post operative sore throat) was 51.4% 42.9% 23.6% 17.1% in the intravenous group compared to 74.3% 65.7% 60% 37.1% in the nebulization group at 2 6 12 and 24 hours respectively Using the clinical.com sample size calculator at the above-mentioned time points Hence, the sample size for 2 6 12 and 24 hours comes out to be 138 148 56 and 152 respectively We will recruit the highest sample size of 152 patients Adding a dropout of 5% the final sample size comes to be 152+ 8= 160 patients
Upon arrival in the preoperative room the patients will receive nebulization with a 5 ml solution for 15-20 minutes and intravenous injection of a 5 ml volume clear solution before wheeling into the operating theatre The intervention will be as per the group allocated as follows

 Group I (Intravenous Dexamethasone)- Nebulization with 0.9% saline (5ml) and intravenous injection of Dexamethasone 0.2 mg/kg diluted to a total volume of 5 ml with 0.9% saline

Group N Nebulization with Dexamethasone 0.2 mg/kg diluted to a total volume of 5 ml with 0.9% saline and 0.9% saline (5 ml)

 

Anaesthesia management will be as per standard institutional protocol Induction of anaesthesia will be with opioids like fentanyl 2 microgram/kg midazolam 0.03 mg/kg and intravenous anaesthetic drugs like propofol 2-3 mg/kg Trachea will be intubated 3 minutes after administering a non-depolarising neuromuscular blocking agent by a conventionally trained anesthesiologist to minimize injury due to inexperience or inadequately relaxed vocal cords Low-pressure high-volume cuffed wire-reinforced armoured endotracheal tube will be used for intubation according to the patient’s gender and build 7-7.5 mm ID(internal diameter) and 8-8.5 mm Internal diameter for females and males respectively Anaesthesia will be maintained with oxygen air plus inhaled anaesthetic agent [Isoflurane/ sevoflurane 1-1.5 MAC(minimum alveolar concentration)]supplemented with intravenous agents like propofol fentanyl etc After intubation we will inflate the cuff with the minimum room air required to prevent an audible air leak with a cuff pressure less than 25 cm of H2O measured using a cuff pressure monitor The number of attempts for intubation time taken for intubation and any difficulty/ trauma during intubation/ laryngoscopy will be noted The fixation distance of the endotracheal tube at the angle of the mouth will be noted We will not insert a Nasogastric tube The patient will be made prone per standard protocol and the endotracheal tube cuff pressure will be rechecked to ensure it is less than 25 cm H2O

During the change of position from supine to prone the breathing circuit will be disconnected to avoid drag on the endotracheal tube At the end of the operation PONV(post operative nause and vomiting) prophylaxis will be given with Injection Ondansetron 0.1 mg/kg The patient will be made supine Displacement of the endotracheal tube if any will be noted The ETT(endotracheal tube) cuff pressure will be rechecked After surgery with the patient adequately anaesthetised the oropharynx will be cautiously toileted with a 12-14Fr disposable soft suction catheter reversal of neuromuscular blockade will be done by IV Neostigmine 0.05 mg/kg along with IV Glycopyrrolate 0.01mg/kg after return of spontaneous ventilation The trachea will be extubated as per standard protocol.We will note the demographic data the time needed for intubation [time from start of laryngoscopy to confirmation of EtCO2(end tidal carbondioxide) on monitor] intubation period (time from intubation to extubation) grade of laryngoscopic view using the Cormack Lehane score number of attempts of intubation incidence of bucking or coughing during tracheal intubation application of external laryngeal pressure to facilitate endotracheal intubation blood in the secretions or endotracheal tube and recovery time (time from the end of the operation to extubation)

Postoperatively at 2 6 12 and 24 hours, the patients will be asked for the presence of postoperative sore throat and hoarseness of voice (which is the change in the quality of speech/voice perceived by the patient themselves or the bystander in the postoperative period or presence of aphonia) dysphagia (known as the difficulty or discomfort in swallowing liquid or solid or both) and stridor (which is a harsh sound during breathing)

 

 


 
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