| CTRI Number |
CTRI/2024/09/073962 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| 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
|
To compare the effect of nebulization with two drugs Dexmedetomidine and Magnesiun sulfate before surgery under general anaesthesia for the prevention of sore throat after intubation |
|
Scientific Title of Study
|
The effect of preoperative nebulized: Dexmedetomidine versus Magnesium sulfate on the prevention of post intubation sore throat |
| 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 Sangeeta Murmu |
| Designation |
Junior resident |
| Affiliation |
Rajendra institute of medical sciences, Ranchi |
| Address |
Department of Anaesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, Pin code- 834009
Ranchi
JHARKHAND
834009
India |
| Phone |
7033533544 |
| Fax |
|
| Email |
sangckp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipali Singh |
| Designation |
Additional professor |
| Affiliation |
Rajendra institute of medical sciences,Ranchi |
| Address |
Department of Anaesthesiology,Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, Pin code- 834009
Ranchi
JHARKHAND
834009
India |
| Phone |
9620310511 |
| Fax |
|
| Email |
dipalishio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipali Singh |
| Designation |
Additional professor |
| Affiliation |
Rajendra institute of medical sciences,Ranchi |
| Address |
Department of Anaesthesiology,Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, Pin code- 834009
Ranchi
JHARKHAND
834009
India |
| Phone |
9620310511 |
| Fax |
|
| Email |
dipalishio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, India, Pin code-834009 |
|
|
Primary Sponsor
|
| Name |
Rajendra institute of medical sciences Ranchi |
| Address |
Department of Anesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, India, Pin code-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 Sangeeta Murmu |
Rajendra Institute of Medical Sciences, Ranchi |
Department of Anesthesiology and General Surgery operation theatre second floor RIMS Bariatu Ranchi Jharkhand India Pincode-834009
Ranchi
JHARKHAND |
7033533544
sangckp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RIMS, 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 |
| Comparator Agent |
0.9% of Normal Saline 5 ml |
Nebulization of the patient with 0.9% of Normal Saline 5 ml for 10 minutes with oxygen at 10 L/ min before 30 minutes prior to the induction of the patient |
| Comparator Agent |
250 mcg Magnesium Sulfate in 5 ml of Normal Saline |
Nebulization of the patient with 250 mcg Magnesium Sulfate in 5 ml of Normal Saline for 10 minutes with oxygen at 10 L/min before 30 minutes prior to the induction of the patient |
| Intervention |
50 mcg Dexmedetomidine in 5 ml of NormalSaline |
Nebulization of the patient with 50 mcg Dexmedetomidine in 5 ml of Normal saline for 10 minutes with oxygen at 10 L/min before 30 minutes prior to the induction of the patient |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anesthesiologist (ASA) physical grade 1 and 2
2. Elective surgery of duration 2-3 hours under general anesthesia |
|
| ExclusionCriteria |
| Details |
1. Patients with previous sore throat or recent upper respiratory tract infection
2. Using steroids or analgesia in the last 48 hours
3. Patients of asthma or chronic obstructive pulmonary disease, neuromascular diseases, mental disease
4. Heavy smokers
5. Allergic to the drugs used in this study
6. Mallampati grade more than 2
7. Obese patients with body mass index more than 35 kg per meter square, pregnant women
8. Intubation time more than 60 seconds and traumatic intubation
4.
|
|
|
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 record the incidence and severity of sore throat after surgery |
0 hour post- surgery
2 hours post- surgery
4 hours post- surgery
6 hours post- surgery
24 hours post- surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To record the hemodynamics- Mean arterial blood pressure, Heart rate
2. To record any related side effects |
At baseline
After nebulization
After laryngoscopy
15 minutes after nebulization
30 minutes after nebulization
45 minutes after nebulization
60 minutes after nebulization
75 minutes after nebulization
90 minutes after nebulization
105 minutes after nebulization
0 hour post- surgery
2 hours post- surgery
4 hours post- surgery
6 hours post- surgery
24 hours post- surgery
|
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
20/09/2024 |
| 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
|
Post- operative sore throat is the eighth most common complication after endotracheal intubation. To prevent post operative sore throat, nebulization will be done before surgery with two drugs- Dexmedetomidine and Magnesium Sulfate and comparison will be done between them.
|