| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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
|
|
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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) |