| CTRI Number |
CTRI/2021/10/037622 [Registered on: 27/10/2021] Trial Registered Prospectively |
| Last Modified On: |
11/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of magnesium sulphate gargle for post operative sore throat |
|
Scientific Title of Study
|
Evaluation of magnesium sulphate gargle for post operative sore throat in patients undergoing general anaesthesia with endotracheal intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Urvashi Mehra |
| Designation |
Postgraduate |
| Affiliation |
VMMC AND SAFDARJUNG HOSPITAL |
| Address |
Department of Anaesthesia and Intensive Care
VMMC and Safdarjung Hospital
New Delhi
DELHI
110029
India |
| Phone |
8588908982 |
| Fax |
|
| Email |
caseystuart1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Jain |
| Designation |
Professor |
| Affiliation |
VMMC AND SAFDARJUNG HOSPITAL |
| Address |
Department of Anaesthesia and Intensive Care
VMMC and Safdarjung Hospital
New Delhi
DELHI
110029
India |
| Phone |
9212308441 |
| Fax |
|
| Email |
shruti.anaesth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Urvashi Mehra |
| Designation |
Postgraduate |
| Affiliation |
VMMC AND SAFDARJUNG HOSPITAL |
| Address |
Department of Anaesthesia and Intensive Care
VMMC and Safdarjung Hospital
New Delhi
DELHI
110029
India |
| Phone |
8588908982 |
| Fax |
|
| Email |
caseystuart1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
Vardhaman Mahavir Medical College |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
Vardhman Mahavir Medical College |
| 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 urvashi mehra |
VMMC and Safdarjung Hospital |
Department of Anaesthesia
New Delhi
DELHI |
8588908982
caseystuart1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age between 18-60yrs undergoing laparoscopic surgery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
PREOPERATIVE MAGNESIUM SULPHATE GARGLES FOR POST OPERATIVE SORE THROAT |
To evaluate the efficacy of pre-operative gargles with magnesium sulphate 20mg/kg diluted upto 30ml with normal saline for post operative sore throat in adult patients undergoing elective laparoscopic surgery under general anaesthesia with endotracheal intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
belonging to ASA physical status 1 and 2 undergoing laparoscopic surgery under general anaesthesia with endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
1) patients with difficult airway.
2) patients with a history of pre-operative sore throat , oral surgeries, asthma , diabetes, chronic obstructive pulmonary disease , head and neck surgeries.
3) patient with known allergies to study drug and rescue drugs.
4) duration of surgery <1hour and >4 hours.
5) patient consuming non steroidal anti inflammatory drugs within 24hours prior to the surgery or on systemic / topical steroid therapy or taken steroid drugs within 5 days prior to surgery. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE THE INCIDENCE AND SEVERITY OF POST OPERATIVE SORE THROAT IN PATIENTS RECEIVING PREOPERATIVE GARGLE OF MAGNESIUM SULPHATE 20MG/KG DILUTED UPTO 30ML WITH NORMAL SALINE UNDERGOING ELECTIVE LAPAROSCOPIC SURGERY UNDER GENERAL ANAESTHESIA WITH ENDOTRACHEAL INTUBATION |
AT 0hr, 2hr, 4hr and 24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate incidence and severity of cough and hoarseness of voice in patients receiving preoperative gargle with magnesium sulphate 20mg/kg diluted upto 30ml with normal saline . |
at 0hr, 2hr, 4hr and 24hr |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
13/11/2021 |
| 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
|
Nil |
|
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-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [caseystuart1993@gmail.com].
- For how long will this data be available start date provided 10-08-2023 and end date provided 11-01-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Primary objective - To evaluate the incidence and severity of post- operative sore throat in patients receiving preoperative gargle magnesium sulphate 20 mg/kg diluted upto 30ml with normal saline undergoing elective laparoscopic surgery under general anaesthesia with endotracheal intubation. Secondary objective - To evaluate incidence and severity of cough and hoarseness of voice in patients receiving preoperative gargle with magnesium sulphate 20mg/kg diluted upto 30ml with normal saline in above study population. |