| CTRI Number |
CTRI/2021/06/034027 [Registered on: 07/06/2021] Trial Registered Prospectively |
| Last Modified On: |
04/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs on sore throat after intubation. |
|
Scientific Title of Study
|
Comparison of dexmedetomidine nebulization and magnesium sulphate nebulization for post operative sore throat after 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 |
K Shanthini |
| Designation |
Specialist |
| Affiliation |
ESIC MC and Hospital |
| Address |
Department of Anaesthesiology ESIC Medical College and PGIMSR Ashok pillar main road KK Nagar Chennai
Department of Anaesthesiology ESIC Medical College and PGIMSR Ashok pillar main road KK Nagar Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9789864692 |
| Fax |
|
| Email |
dr.shanthu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
TS Nandhini |
| Designation |
Specialist |
| Affiliation |
ESIC MC and Hospital Ethical committee |
| Address |
Department of Anaesthesiology ESIC Medical College and PGIMSR Ashok pillar main road KK Nagar Chennai
Department of Anaesthesiology ESIC Medical College and PGIMSR Ashok pillar main road KK Nagar Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
7550238528 |
| Fax |
|
| Email |
ganeshbabu.nandhini29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K Shanthini |
| Designation |
Specialist |
| Affiliation |
ESIC MC and Hospital Ethical committee |
| Address |
Department of Anaesthesiology ESIC Medical College and PGIMSR Ashok pillar main road KK Nagar Chennai
Department of Anaesthesiology ESIC Medical College and PGIMSR Ashok pillar main road KK Nagar Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9789864692 |
| Fax |
|
| Email |
dr.shanthu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
ESIC Medical college & PGIMSR
Chennai |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Shirishkumar chavan |
ESIC Medical college and PGIMSR |
Department of Anaesthesiology ESIC Medical College and PGIMSR Ashok pillar main road KK Nagar Chennai
Chennai
TAMIL NADU |
9947098333
drshirishchavan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC ESIC MC PGIMSR |
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 |
Dexmedetomidine is given as Nebulisation for surgeries requiring General Anaesthesia. |
Dexmedetomidine 0.5 microgram made into 5 ml using normal saline and is nebulised using face mask once 15 minutes prior to general anaesthesia in the pre operative holding area. |
| Comparator Agent |
Magnesium Sulphate is given as nebulization for surgeries requiring General Anaesthesia with Endotracheal intubation. |
Magnesium sulphate 225 mg (0.5ml of 50% solution )made into 5 ml using normal saline and is nebulised using face mask once 15 minutes prior to general anaesthesia in the pre operative holding area. |
| Intervention |
Nebulisation |
Nebulisation with either dexmedetomidine or magnesium sulphate solution of 5 ml is done using face mask once 15 minutes prior to general anaesthesia in the pre operative holding area. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
i) Informed Written consent
ii) Age between 18-65 years.
iii) Patients undergoing surgery under general anesthesia.
iv) ASA - 1 and ASA - II
iv) Duration of surgery within 3 hrs
|
|
| ExclusionCriteria |
| Details |
1.Emergency surgeries
2.Patients undergoing Tonsil,thyroid and other throat surgeries.
3.Surgeries more than 3 hrs duration.
4.Allergy to study drugs – to prevent anaphylaxis
5.Patients on pain medication,Calcium channel blockers,Quinolones And tetracyclines.
6.Myasthenia Gravis and Heart blocks.
7.Chronic renal failure and pre existing myopathy
|
|
|
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 |
| Comparing efficacy of Magnesium sulphate and Dexmedetomidine nebulization for postoperative sore throat after general anaesthesia with endotracheal intubation |
0,2,4,8,16 and 24 hrs after general anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the side effects and adverse events of Magnesium Sulphate and Dexmedetomidine nebulization. |
0,2,4,8,16 and 24 hrs after General anaesthesia. |
|
|
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)
|
15/06/2021 |
| 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
|
Will be published after studying. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
100 patients of 18-65 yrs age,posted for surgeries requiring general anaesthesia with endotracheal intubation under ASA1to ASA3,for surgeries less than 3hrs will be given one of the two study drugs Magnesium Sulphate 225 mg or Dexmedetomidine0.5 mg by nebulization.Standardized General Anaesthesia with intra-operative vitals will be recorded. Post operative rescue analgesic given at 0,1,2,6,12 and 24 hrs. All adverse events as in allergic reaction,muscle weakness,prolonged sedation,and diarrhoea will be recorded. The incidence of sore throat in both groups measured and the best drug is derived by statistical methods.
|