| CTRI Number |
CTRI/2025/07/089940 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing the effects of Dexmedetomidine vs Magnesium Sulphate nebulisation in reducing sore throat in patients undergoing general anaesthesia |
|
Scientific Title of Study
|
Comparison of nebulized Dexmedetomidine vs Magnesium Sulphate for the attenuation of postoperative sore throat in patients undergoing general anaesthesia |
| 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 Ashley Eapen |
| Designation |
Post graduate student |
| Affiliation |
Believers Church Medical College Hospital |
| Address |
Department of Anaesthesia, Believers Church Medical College Hospital, St.Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala, 689103
Pathanamthitta KERALA 689103 India |
| Phone |
8606093091 |
| Fax |
|
| Email |
ashleyeapen18@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Litha Mary Mathew |
| Designation |
Associate Professor |
| Affiliation |
Believers Church Medical College Hospital |
| Address |
Department of Anaesthesia, Believers Church Medical College Hospital, St.Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala, 689103
Pathanamthitta KERALA 689103 India |
| Phone |
9447349649 |
| Fax |
|
| Email |
lthmathew@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Litha Mary Mathew |
| Designation |
Associate Professor |
| Affiliation |
Believers Church Medical College Hospital |
| Address |
Department of Anaesthesia, Believers Church Medical College Hospital, St.Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala, 689103
Pathanamthitta KERALA 689103 India |
| Phone |
9447349649 |
| Fax |
|
| Email |
lthmathew@gmail.com |
|
|
Source of Monetary or Material Support
|
| Believers Church Medical College Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Ashley Eapen |
| Address |
Believers Church Medical College Hospital, St.Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala, 689103 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Ashley Eapen |
Believers Church Medical College Hospital |
Operation theatre complex, Believers Church Medical College Hospital, St. Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala, 689103 Pathanamthitta KERALA |
8606093091
ashleyeapen18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Believers Church Medical College Hospital |
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 |
Dexmedetomidine |
Dexmedetomidine at a dose of 1 mcg/kg was diluted with normal saline to a total volume of 5 ml in a 5 cc syringe and administered as a single preoperative dose via a nebulisation mask by a trained anaesthetist. The nebulisation was driven by an oxygen source set at 8 L/min and 50 psi, delivered over a period of 15 minutes |
| Comparator Agent |
Magnesium Sulphate |
Magnesium Sulphate at a dose of 250 mg was diluted with normal saline to a total volume of 5 ml in a 5 cc syringe and administered as a single preoperative dose via a nebulisation mask by a trained anaesthetist. The nebulisation was driven by an oxygen source set at 8 L/min and 50 psi, delivered over a period of 15 minutes. |
| Intervention |
Preoperative Nebulisation with study drugs for prevention of post operative sore throat |
Preoperative Nebulisation with Dexmedetomidine or Magnesium Sulphate for prevention of postoperative sore throat |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA-PS I-II
2. Posted for elective surgical procedures in supine position under general
anaesthesia with endotracheal intubation
3.Duration of surgery : 2-5 hours |
|
| ExclusionCriteria |
| Details |
1. Patients who refuse or lack the capacity to give consent
2. History of preoperative sore throat, respiratory tract infection,
chronic lung diseases
3. Known allergy to the study drug
4. Pregnancy
5. Anticipated difficult airway
6. BMI greater than 30 kg/m2
7. Patients undergoing oral, nasal, head and neck surgeries
8. Requiring more than one attempt at intubation |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of the sore throat, hoarseness of voice and cough in the postoperative period in patients prophylactically treated with Dexmedetomidine or Magnesium Sulphate undergoing elective surgeries under general anaesthesia with tracheal intubation |
Postoperatively at 0, 2, 4 and 6 hours from the time of extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of nebulization of the study drugs on respiratory rate and hemodynamic parameters such as heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure |
Postoperatively at 0, 2, 4 and 6 hours from the time of extubation |
|
|
Target Sample Size
|
Total Sample Size="206" Sample Size from India="206"
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 3 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="7" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ashleyeapen18@gmail.com].
- For how long will this data be available start date provided 23-03-2028 and end date provided 23-03-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Postoperative sore throat (POST) is a common complication following surgeries performed under general anaesthesia. The incidence of POST in patients undergoing tracheal intubation for general anaesthesia (GA) is 6.6-90 percentage. It is a double-blind randomized controlled trial to compare the effects of Dexmedetomidine and Magnesium Sulphate nebulisations on attenuation of sore throat, hoarseness of voice and cough in the postoperative period in patients undergoing elective surgeries under general anaesthesia with tracheal intubation. Patients fulfilling the inclusion criteria will be enrolled in the study and assessed prior to surgery. Predisposing factors such as cigarette smoking, gastroesophageal reflux disease, long-term use of corticosteroids and non-steroidal anti-inflammatory drugs will be captured. Patients will be informed about the study and informed consent will be obtained. Participants will be randomly allocated into two groups using the fishbowl technique.One group will receive Dexmedetomidine at a dose of 1 mcg/kg, while the other group will receive 250 mg of Magnesium Sulphate. Dexmedetomidine (brand name: Dexem) and Magnesium Sulphate (brand
name: Magneon) are available in the form of intravenous injection solutions,
supplied in ampoules. They are diluted with normal saline for use via
nebulisation. Both will be diluted with normal saline to a 5 mL solution in a 5 cc syringe and administered by a trained anaesthetist through a nebulization mask connected to wall-mounted, oxygen driven source (8 L/min, 50 psi) for 15 min. General anaesthesia (GA) will be induced after completing nebulization. Sore throat, hoarseness of voice, cough, haemodynamic parameters and respiratory rate will be measured at 0, 2, 4 and 6 hours from the time of extubation. POST would be graded on a four-point scale (0–3). This study seeks in formulating interventions for decreasing sore throat, cough and hoarseness of voice in the postoperative period that would help to improve the quality of postoperative recovery. |