| CTRI Number |
CTRI/2023/05/052303 [Registered on: 04/05/2023] Trial Registered Prospectively |
| Last Modified On: |
03/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison between nebulization by ketamine versus magnesium sulphate on incidence of post operative sore throat after endotracheal intubation |
|
Scientific Title of Study
|
A randomized comparative study of effect of preoperative nebulization with ketamine versus magnesium sulphate on incidence of postoperative sore throat in patient undergoing surgery in 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 |
Ramandeep Kaur |
| Designation |
Junior resident |
| Affiliation |
subharti medical college and hospital |
| Address |
Room no. 02, Ground floor, Begum Hazrat Mahal Girls Hostel, Subharti Medical College And Hospital, Meerut
UTTAR PRADESH
250001
India
Meerut
UTTAR PRADESH
250001
India |
| Phone |
8755026625 |
| Fax |
|
| Email |
ramansr31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhawana Rastogi |
| Designation |
Professor and HOD |
| Affiliation |
subharti medical college and hospital |
| Address |
Department of Anaesthesia, Subharti Medical College And Hospital, Meerut
UTTAR PRADESH
250001
India
Meerut
UTTAR PRADESH
250001
India |
| Phone |
8449114984 |
| Fax |
|
| Email |
28bhawana75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramandeep Kaur |
| Designation |
Junior resident |
| Affiliation |
subharti medical college and hospital |
| Address |
Room no. 02, Ground floor, Begum Hazrat Mahal Girls Hostel, Subharti Medical College And Hospital, Meerut
UTTAR PRADESH
250001
India
Meerut
UTTAR PRADESH
250001
India |
| Phone |
8755026625 |
| Fax |
|
| Email |
ramansr31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Subharti medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Ramandeep Kaur |
| Address |
Begum Hazrat Mahal Girls Hostel, Subharti Medical College and Hospital, Meerut |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SUBHARTI MEDICAL COLLEGE |
Subhartipuram, NH-58, Delhi Haridwar Bypass Road, Uttar Pradesh 250005 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ramandeep Kaur |
subharti medical college and hospital |
Subharti Puram, NH-58, Delhi Haridwar Bypass Road, Uttar Pradesh 250005, Meerut
Meerut
UTTAR PRADESH |
8755026625
ramansr31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMMITTEE (MEDICAL) SWAMI VIVEKANAND SUBHARTI UNIVERSITY |
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 |
Ketamine for Preoperative Nebulization |
Nebulization for 10 mins preoperatively with Ketamine. |
| Comparator Agent |
Magnesium Sulphate for preoperative nebulization. |
Nebulization for 10mins preoperatively with Magnesium Sulphate. |
| Comparator Agent |
Normal Saline for Preoperative nebulization |
Nebulization for 10mins preoperatively with normal saline |
| Intervention |
Preoperative nebulization |
Preoperative nebulization with 250mg MgSo4 through nasal route, once for 10 minutes.
Preoperative nebulization with 50mg ketamine through nasal route, once for 10 minutes.
Preoperative nebulization with 3ml Normal Saline through nasal route, once for 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1-2
Supine position under General Anaesthesia
Informed Consent |
|
| ExclusionCriteria |
| Details |
Patients with Physical Status of ASA Grade 3 or greater
Preoperative sore throat
Upper airway infection
Duration of surgery >120 mins
Oral surgeries
Pregnant women
Severe cardiorespiratory, hepatic, renal, neurological or endocrinal disease
Patients with known hypersenstivity or drug allergies
Obese patients weight >80kg
Epileptic patient
Nausea, retching or vomiting within 48hr before surgery
History of motion sickness
Patients who refuse to participate in the study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the incidence of postoperative sore throat after magnesium sulphate and ketamine nebulization and normal saline nebulization.
To evaluate and compare effect on hemodynamics of the patient after magnesium sulphate and ketamine nebulization and normal saline nebulization. |
0 hour, 2 hours, 6 hours, 8 hours, 12hours, 24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate side effect (if any) of ketamine and magnesium sulphate.
To evaluate patients satisfaction with nebulization done by ketamine and magnesium sulphate. |
3mins, 5mins, 10mins, 15mins, 20mins, 25mins, 30mins, 40mins, 50mins, 60mins |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Comparison of effect of preoperative nebulization with Ketamine versus Magnesium Sulphate on incidence of postoperative sore throat in patient undergoing surgery in general anaesthesia with endotracheal intubation. Purpose of trial is to compare the incidence of sore throat at 0hours, 2hours, 6 hours, 8hours, 12hours, 24hours. Hemodynamic parameters are compared. Preoperative nebulization will be done for 10mins with ultrasonic/mesh nebuliser machine. |