| CTRI Number |
CTRI/2025/09/095450 [Registered on: 29/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of three different methods- nebulisation with Dexmedetomidine, Inj Dexamethasone intravenously and intra-cuff Lignocaine, for the prevention of sore throat in the postoperative period for patients undergoing surgeries under general anaesthesia. |
|
Scientific Title of Study
|
Comparison of Nebulized Dexmedetomidine, Intravenous Dexamethasone and Intra-cuff Lignocaine for Prevention of Postoperative Sore Throat: A Randomized 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 |
Pranati Yerramilli |
| Designation |
Postgraduate |
| Affiliation |
SRM Medical College Hospital and Research Center |
| Address |
Department of Anaesthesiology, SRM Medical College Hospital and Research Center, Potheri, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9176370850 |
| Fax |
|
| Email |
pranatiyerramilli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Venkatraman R |
| Designation |
Professor |
| Affiliation |
SRM Medical College Hospital and Research Center |
| Address |
Department of Anaesthesiolgy, SRM Medical Hospital and Research Center, Potheri, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9894581455 |
| Fax |
|
| Email |
drvenkat94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Venkatraman R |
| Designation |
Professor |
| Affiliation |
SRM Medical College Hospital and Research Center |
| Address |
Department of Anaesthesiolgy, SRM Medical Hospital and Research Center, Potheri, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9894581455 |
| Fax |
|
| Email |
drvenkat94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Potheri, Kattankulathur, Kancheepuram, 603203 |
|
|
Primary Sponsor
|
| Name |
SRM Medical College |
| Address |
Department of Anaesthesiology, SRM Medical College Hospital and Research Center, Potheri, Kattankulathur, Kancheepuram, 603203 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Pranati Yerramilli |
SRM Medical College Hospital |
Room no 209, B block, second floor, Department of Anaesthesiology, SRM Medical College Hopital and Research Center, Potheri, Kattankulathur, Kancheepuram, 603203
Kancheepuram
TAMIL NADU |
9176370850
pranatiyerramilli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intra cuff Lignocaine |
Cuff of endotracheal tube will be inflated with lignocaine |
| Comparator Agent |
Intravenous Dexamethasone |
Dexamethasone 8mg IV will be given 30 min after intubation. |
| Intervention |
Nebulization with Dexmedetomidine |
Nebulization with dexmedetomidine given 15 min before induction of anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS 1 and 2
Patients undergoing elective surgeries under general anaesthesia with endotracheal intubation
Duration of surgery more than one hour
Normal BMI |
|
| ExclusionCriteria |
| Details |
Patients with history of respiratory diseases or Diabestes
History of smoking in last one week
Allergy to local anaesthetic agent
Surgeries in prone position
Patient refusal |
|
|
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 and severity of post operative sore throat |
Assessed at 2, 6, 12 and 24 hours in the postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of postoperative nausea and vomiting |
Upto 12 hours in postoperative period |
| Intraoperative blood Pressure and Heart rate monitoring |
Monitored at 15 minute intervals intraoperatively |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2025 |
| Date of Study Completion (India) |
03/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
After obtaining institutional ethical and CTRI approval, and obtaining patient consent, patients undergoing elective surgeries under general anaesthesia will be divided into 3 groups by computer generated random numbers and sealed envelope method. General anaesthesia is standardized, all patients will receive T Alprazolam 0.25mg as premedication on night prior to surgery. Intraoperatively all monitors will be attached, patients will be induced with Inj Fentanyl 2mcg/kg, Inj Propofol 2mg/kg, Inj Vecuronium 0.1mg/kg and intubated with appropriate size endotracheal tube. Intraoperative pain management with Inj Paracetamol 1g and additional doses of Inj Fentanyl.Group N- Nebulized Dexmedetomidine - These patients will receive nebulization with dexmedetomidine 50mcg along with 1.5ml of saline 15 min before induction - Distilled water will be injected into the cuff of the ETT to obtain minimal occlusive volume - 2ml saline will be given IV 30 min after intubation
Group D- Intravenous Dexamethasone - These patients will receive nebulization with 2ml saline 15 min before induction - Distilled water will be injected into the cuff of the ETT to obtain minimal occlusive volume -Inj Dexamethasone 8mg IV will be given 30 min after intubation
Group T- Intra-cuff Lignocaine -These patients will receive nebulization with 2ml saline 15 min before induction - The cuff of the ETT will be inflated with 2 percent Lignocaine to obtain minimal occlusive volume and intra-cuff pressure will be maintained between 20-30 cm of water -2ml saline will be given IV 30 min after intubation
A second anaesthetist will monitor the patient throughout the procedure and assess the outcomes.
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