| CTRI Number |
CTRI/2019/08/020785 [Registered on: 20/08/2019] Trial Registered Retrospectively |
| Last Modified On: |
19/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Magnesium Sulphate and Ketamine Nebulization in preoperative period for prevention of postoperative Sore throat and other airway morbidities |
|
Scientific Title of Study
|
comparison of effect of magnesium sulphate nebulization and ketamine nebulization in prevention of postoperative sore throat |
| Trial Acronym |
Prevention of Postoperative sore throat |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archana H P |
| Designation |
Post graduate student |
| Affiliation |
M S Ramaiah Hospital Banglore |
| Address |
Archana H P
Door no. 1678, K block
Ramakrishna nagar
Mysore
Mysore
KARNATAKA
570022
India |
| Phone |
7353870570 |
| Fax |
|
| Email |
archanahp4u@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M C Nagaraj |
| Designation |
Professor and HOD |
| Affiliation |
M S Ramaiah Hospital Banglore |
| Address |
M C Maharaj
Professor and HOD
Dept of Anesthesiology
M S Ramaiah Hospital
Bangalore
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9972849779 |
| Fax |
|
| Email |
nagarajmc58@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Archana Parameswar |
| Designation |
Post graduate student |
| Affiliation |
M S Ramaiah Hospital Banglore |
| Address |
Archana H P
Door no. 1678, K block
Ramakrishna nagar
Mysore
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
7348985534 |
| Fax |
|
| Email |
archanahp4u@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia M S Ramaiah Hospital Banglore |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesia |
| Address |
Department of Anesthesia
M S Ramaiah Medical college & Hospital, Bangalore
Karnataka, India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| M S Ramaiah Hospitals |
Department of Anaesthesia
M S Ramaiah Hospital
Bangalore
Karnataka, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Archana H P |
M S Ramaiah Hospital |
Department of Anesthesia
M S Ramaiah medical college & Hospital Bangalore
Mysore
KARNATAKA |
7353870570
archanahp4u@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M S Ramaiah Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, Postoperative Sore Throat, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ketamine |
Effect of Preoperative Nebulization with Ketamine in prevention of post operative sore throat. |
| Comparator Agent |
Magnesium Sulphate |
Effect of Preoperative Nebulization with Magnesium Sulphate in prevention of post operative sore throat. |
| Comparator Agent |
Normal saline |
Effect of Preoperative Nebulization with Normal Saline in prevention of post operative sore throat. |
| Intervention |
Preoperative Nebulization with study drugs for prevention of post operative sore throat |
Preoperative Nebulization with Ketamine or magnesium sulphate or saline for prevention of post operative sore throat |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients giving informed written consent
2. ASA physical status I-III.
3. Malampati Grade I-II.
4. Patients scheduled for elective surgery under GA with Tracheal intubation.
|
|
| ExclusionCriteria |
| Details |
1. Surgical procedures of >2hours(H) duration & ENT surgeries on the adenoids, Tonsils & Ear and Intra-Oral surgeries.
2. Prone positions or steep trendelenberg or Anti-Trendelenberg Position.
3. H/o URTI in the previous 2 weeks.
4. H/o Smoking .
5. H/o reactive airway disease & already on bronchodilator nebulization.
6. Endotracheal (ET) Tube cuff pressure >25 cmH2O in order to obtain airtight seal.
7. H/o allergy to MgSo4 and /or Ketamine.
8. More than 2 attempts at laryngoscopy & intubation.
9. Procedures necessitating Nasogastric tube insertion.
10. Laproscopic procedures (prolonged) involving higher airway pressures of >30cmH2O
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the incidence and severity of Postoperative sore throat by preoperative nebulization of Magnesium sulphate 300mg or Ketamine 50mg |
Postoperatively at 0 2 4 12 and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in the incidence & severity of
Postoperative Dysphagia .
Postoperative Hoarseness of voice.
Postoperative cough
|
Postoperatively at 0 2 4 12 and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="111"
Sample Size from India="111"
Final Enrollment numbers achieved (Total)= "111"
Final Enrollment numbers achieved (India)="111" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/08/2017 |
| Date of Study Completion (India) |
15/10/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Prospective randomized double blind study titled “Comparison of effect of Magnesium Sulphate Nebulization and Ketamine nebulization in prevention of postoperative Sore throat†was undertaken at M.S.Ramaiah Hospitals, Bangalore. The study was conducted on 111 patients belonging to ASA 1, 2 and 3 undergoing elective surgery under general anaesthesia with tracheal intubation. Study subjects were divided into three study groups. Patients in Group M were nebulized with 3ml (300mg) of Magnesium Sulphate, Group K with 3ml (50mg) of Ketamine and Group S with 3ml Normal Saline. Nebulization was administered 15minutes prior to the surgery and general anaesthesia was induced 5minutes after Nebulization. Hemodynamic monitoring was done pre nebulization, post nebulization and post induction. Postoperatively patients were assessed for incidence and severity of POST, hoarseness of voice, dysphagia and cough at intervals of 0, 2, 4, 12 and 24 hours postoperatively. The incidence of POST was significantly less in Group M (13.5%) and Group K (2.7%) when compared to Group S (94.6%). There was also significant reduction in the incidence and severity of Postoperative hoarseness, dysphagia and cough at 0, 2 and 4 hours in Group M and Group K when compared to Group S. Thus it can be concluded that Preoperative Nebulization with Magnesium sulphate 300mg or Ketamine 50mg is an effective method for preventing Postoperative Sore throat, hoarseness, dysphagia and cough in patients undergoing elective surgery under General anaesthesia with tracheal intubation. |