| CTRI Number |
CTRI/2024/03/063567 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of post operative sore throat, hoarseness of voice and cough after nebulization with ketamine and magnesium sulphate in patients undergoing general anaesthesia. |
|
Scientific Title of Study
|
A randomized double blind comparative study of incidence and severity of post operative sore throat,hoarseness of voice and cough after nebulization with ketamine and magnesium sulphate in patients undergoing general anaesthesia with endotracheal intubation. |
| 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 Veena Mathur |
| Designation |
Senior professor |
| Affiliation |
JLN Medical College, Ajmer |
| Address |
HOD and Senior professor
Department of Anaesthesiology
JLN Medical college
Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Mathur |
| Designation |
Senior professor |
| Affiliation |
JLN Medical College, Ajmer |
| Address |
HOD and Senior professor
Department of Anaesthesiology
JLN Medical college
Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Mathur |
| Designation |
Senior professor |
| Affiliation |
JLN Medical College, Ajmer |
| Address |
HOD and Senior professor
Department of Anaesthesiology
JLN Medical college
Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460517947 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
|
Source of Monetary or Material Support
|
| JLN Medical College
Ajmer, Rajasthan - 305001 |
|
|
Primary Sponsor
|
| Name |
JLN Medical College |
| Address |
JLN Medical College.
Ajmer
Rajasthan |
| 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 Makhan Lal Yadav |
JLN Medical College Ajmer Rajasthan |
Department of Anesthesia
New OT Complex, 1st floor emergency building.
Ajmer
RAJASTHAN |
8104500288
drmakhanlalyadav84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee JLN Medical college |
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 |
nebulization with ketamine and normal saline |
Incidence and severity of post operative sore throat, hoarseness of voice and cough after nebulization with ketamine 50 MG and normal
saline 4ml in patients undergoing general anesthesia with endotracheal intubation. The patients receive the drug via nebulization mask connected to wall mounted oxygen driven source (8L, 50 psi) for 15 min prior to surgery.Sore throat hoarseness of voice and cough assesment will be done at immediate recovery (0 hour after extubation) and 2,4,6,12,24 hours postoperatively. |
| Comparator Agent |
Nebulization with magnesium sulfate and normal saline |
Incidence and severity of post operative sore throat, hoarseness of voice and cough after nebulization with Magnesium sulfate 500MG and normal saline 4ml in patients undergoing general anesthesia with endotracheal intubation. The patients receive the drug via nebulization mask connected to wall mounted oxygen driven source (8L, 50 psi) for 15 min prior to surgery.Sore throat hoarseness of voice and cough assesment will be done at immediate recovery (0 hour after extubation) and 2,4,6,12,24 hours postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18- 60 years of either sex
Undergoing surgeries under general anaesthesia in supine position
Duration of surgery upto 2hours
ASA physical status -I & II |
|
| ExclusionCriteria |
| Details |
Age- <18 and >60 yrs
ASA physical status III & above
Mallampatti grade >2
Any psychiatric disorder and history of epilepsy
Neurological patients with raised Intracranial pressure
Patients with known coronary artery disease,old myocardial infarction and ischemic heart disease
Pregnancy
Patients sensitive or allergic to study drugs
History of pre operative sore throat, oral surgeries, asthma ,chronic obstructive pulmonary disease, head and neck surgeries
Recent non steroidal drugs medication
Anticipated difficult intubation
Patients those who will require>2attempts at intubation
Patients and/ or his/her legally acceptable representative not willing to provide their voluntary written informed consent for participation in the study |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence and severity of sore throat, hoarseness of voice and cough |
24 hours postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| haemodynamic changes, side effects |
24 hours post operative period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
12/03/2024 |
| 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
|
This will be a hospital based prospective, randomized, double blind study conducted to comparative study of incidence and severity of post operative sore throat, hoarseness of voice and cough after nabulisation with ketamine and magnesium sulphate in adult patients undergoing various surgeries under general anaesthesia with endotracheal intubation.For this study adult population is between 18 to 60 years of age group ASA grade 1 or 2 with exemption of all the exclusion criteria mentioned above and undergoing general anesthesia. The primary objective of the study is to assess incidence and severity of post-operative sore throat, hoarseness of voice and cough after extubation . The secondary objective of the study is to assess to hemodynamic changes before and after giving nabulisation and any complication associated. Participants will be allocated in two different group each with 50 number sample size. Group K will receive nabulisation with Ketamine (50mg) 1ml with 4 ml normal saline and group M will receive nabulisation Magnesium sulphate (500mg)1ml with 4ml normal saline. Both the drugs are nabulisation 15 minutes prior to the endotracheal intubation. Preanesthetic evaluation will be done on the day before surgery. Since the patient enrolled in the surgery were adults, patents need to give full information regarding the study with informed risk consent. All preparation for general anesthesia with emergency cart will be kept ready in prior. Adult will be induced after proper preoxygenation and premedication and later with muscle relaxant in adequate dosage at optimum depth of anesthesia. Adult will be nabulisation with above mentioned drugs 15 minutes prior to intubation. Patient will be monitored intraoperatively and postoperatively upto 24 hours at pre described time interval and documented. Data will be analyzed statistically using standard quantitative and qualitative tests.
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