| CTRI Number |
CTRI/2023/09/057713 [Registered on: 15/09/2023] Trial Registered Prospectively |
| Last Modified On: |
05/09/2023 |
| 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
|
To compare the efficacy of preoperative nebulization with magnesium sulfate and normal saline in reducing the incidence of postoperative sorethroat following tracheal intubation in patients receiving general anaesthesia |
|
Scientific Title of Study
|
Effect of Magnesium Sulfate nebulisation on incidence of postoperative sorethroat; A Randomized prospective 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 |
Dr Priyadharshini E U |
| Designation |
Junior Resident Academic |
| Affiliation |
Rajendra Institute of Medical Sciences, Ranchi |
| Address |
Department of Anaesthesiology,
RIMS, Bariatu, Ranchi - 834009, Jharkhand
Ranchi JHARKHAND 834009 India |
| Phone |
9597012289 |
| Fax |
|
| Email |
eupriyadharshini97@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dipali Singh |
| Designation |
Addititonal Professor |
| Affiliation |
Rajendra Institute of Medical Sciences, Ranchi |
| Address |
Department of Anaesthesiology,
RIMS, Bariatu, Ranchi - 834009, Jharkhand
Ranchi JHARKHAND 834009 India |
| Phone |
9620310511 |
| Fax |
|
| Email |
dipalishio@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Manisha Bhagat |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra Institute of Medical Sciences, Ranchi |
| Address |
Department of Anaesthesiology,
RIMS, Bariatu, Ranchi - 834009, Jharkhand
Ranchi JHARKHAND 834009 India |
| Phone |
9386269477 |
| Fax |
|
| Email |
bhagatmanisha7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of Medical Sciences,Ranchi,Bariatu,Ranchi,Jharkhand 834009 |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences Ranchi |
| Address |
Bariatu,Ranchi,Jharkhand 834009 |
| Type of Sponsor |
Government 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 |
| Dr Priyadharshini E U |
Rajendra Institute of Medical Sciences Ranchi |
Surgery OT,
3rd Floor, Old Building,
Rajendra Institute of Medical Sciences,Ranchi,Bariatu,Ranchi Jharkhand 834009 Ranchi JHARKHAND |
9597012289
eupriyadharshini97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Rajendra Institute of Medical Sciences, Ranchi |
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 |
| Intervention |
Magnesium Sulfate |
Pre induction nebulization with magnesium sulfate 250 mg in 3ml of normal saline over 15 minutes before intubation. |
| Comparator Agent |
Normal Saline |
Pre induction nebulization with 3ml of 0.9% normal saline over 15 minutes before intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II
Duration of surgery being less than 2 hours |
|
| ExclusionCriteria |
| Details |
ASA grade III & IV
Age <18years and >60 years
Pregnant patient
Refusal of consent for procedure
Allergy or hypersensitivity to magnesium drugs
Pateints undergoing ENT,dental,neck surgeries
Procedures lasting for more than 2 hours
Patients having pre-operative sore throat,cough,hoarseness of voice
Patients receiving IV/ Nebulisation with steroids
Patients having anticipated difficult airway(Mallampati III & IV |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of preoperative nebulization with magnesium sulfate 250mg in 3ml of normal saline versus 3ml of 0.9% normal saline in reducing the incidence of post operative sore throat following tracheal intubation with endotracheal tube in patients receiving general anaesthesia. |
Before induction.
at 0 hour of immediate extubation.
at 4th hour post op
at 8th hour post op
at 12th hour post op
at 24th hour post op
at 48th hour post op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the reduction in the incidence of cough & hoarseness of voice following nebulization with magnesium sulfate and normal saline in the post operative period. |
Before induction.
at 0 hour of immediate extubation.
at 4th hour post op
at 8th hour post op
at 12th hour post op
at 24th hour post op
at 48th hour post op |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
18/09/2023 |
| 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="0" 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
|
Sore throat is a common complication in post operative period after tracheal intubation, and one of the most common undesirable anaesthesia associated problems. The incidence of post operative sore throat (POST) has been found to be as high as 21% - 65%. The factors known for post operative sore throat include age, sex, larger tracheal tubes, cuff design, intracuff pressures, mechanical injury during laryngoscopy and intubation, continuous pressure by the inflated tracheal tube cuff on tracheal mucosa causing injury and dryness of the mucosa. The use of Nitrous oxide also increases incidence of post operative sore throat. Thus various measures has been attempted to reduce the incidence of POST- Some among these are non pharmacological and some pharmacological. Gentle endotracheal intubation for elective surgeries in a single attempt with avoidance of inadvertent trauma to the airway accounts for minimal incidence of sore throat. Awareness and knowledge about the potential risk factors and precautions may thereby help to reduce this complication. These factors include avoidance of large endotracheal tubes, careful airway instrumentation, decreasing the number of attempts of both laryngoscopy and intubation, intubation after full relaxation of larynx, gentle oropharyngeal suctioning and extubation when the tracheal tube is fully deflated. Besides inflating the bulb of endotracheal tube to a pressure <20mmHg and regular checking of cuff pressure also reduces post operative sore throat. Pre-emptive application of locally active analgesic and anti inflammatory agents can presumably decrease the discomfort, airway inflammation and in turn sore throat. Pharmacological measures include inhalation of beclomethasone and fluticasone, gargling with azulene sulfonate, aspirin, benzydamine hydrochloride and licorice, ketamine as gargle or nebulization, intracuff application of alkalized lignocaine and application of lignocaine spray. It is an established fact that NMDA receptors (N- methyl D- aspartate) play a role in nociception and inflammation and these receptors are known to be present in central and peripheral nervous system. NMDA antagonists such as magnesium sulfate and ketamine work on peripheral nerve endings in the mucosal lining of the upper airway which in turn may reduce the incidence of sore throat. Moreover magnesium sulfate being an antagonist to NMDA receptors further prevents sensitization to the peripheral pain stimulus. Various studies have used magnesium sulfate in the form of nebulization in various doses. Nebulization is considered better than other methods as it is easy to administer, smaller volume of drugs with low systemic adverse effects are delivered and better acceptance forpatients may be achieved . With this background the present study was planned to evaluate the efficacy of preoperative magnesium sulfate nebulization to reduce the incidence of post operative sore throat in patients undergoing elective surgeries with general anaesthesia with endotracheal intubation. |