| CTRI Number |
CTRI/2022/09/046003 [Registered on: 28/09/2022] Trial Registered Prospectively |
| Last Modified On: |
24/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of two different drugs(ketamine and 3%NS) filled in definite airway tube and its results on extubation response vitals and post operative sorethroat, hoarseness,cough response. |
|
Scientific Title of Study
|
Comparative effect of intracuff 3% Normal saline and Ketamine on extubation hemodynamic response, incidence and severity of post operative sore throat – A Prospective Randomised study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Srujan goud |
| Designation |
Senior resident |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
ESIC Medical College and Super specialty Hospital
Department of Anesthesiology
1st floor operation theatre complex Sanath nagar Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
7780395335 |
| Fax |
|
| Email |
sruj0029@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravikanth pula |
| Designation |
Associate professor |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
ESIC Medical College and Super speciality Hospital
Department of Anaesthesiology
1st floor operation theatre complex Sanath nagar Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9666977781 |
| Fax |
|
| Email |
ravipula99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR R SRUJAN GOUD |
| Designation |
SENIOR RESIDENT |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
ESIC Medical College and Super speciality Hospital
Department of Anaesthesiology
1st floor operation theatre complex Sanath nagar Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
7780395335 |
| Fax |
|
| Email |
sruj0029@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC MEDICAL COLLEGE AND SUPER SPECIALITY HOSPITAL |
|
|
Primary Sponsor
|
| Name |
ESIC MEDICAL COLLEGE AND SUPER SPECIALITY HOSPITAL |
| Address |
ESIC medical college and super speciality hospital
sanath nagar hyderabad 500038 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR RAVIKANTH PULA |
ESIC MEDICAL COLLEGE AND SUPER SPECIALITY HOSPITAL SANATH NAGAR HYDERABAD 500038 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR R SRUJAN GOUD |
ESIC MEDICAL COLLEGE AND SUPER SPECIALITY HOSPITAL |
Department of anesthesiology
ESIC SSH
1st Floor operation theatre complex Sanath nagar
HYDERABAD 500038
Hyderabad
TELANGANA |
7780395335
sruj0029@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ESIC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, (2) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ketamine |
Instillation of drug ketamine 50mg in endotracheal tube cuffs after intubation and maintain cuff pressures around 20-25mmHg |
| Comparator Agent |
3% Normal saline |
Instillation of required volume of 3% normal saline in endotracheal tube cuffs after intubation and maintain cuff pressures around 20-25mmHg |
| Intervention |
Intracuff instillation of required volume of 3% Normal saline |
After intubation endotracheal tube cuff filled with required volume of 3% normal saline to maintain the cuff pressure of 20 -25mmHg measured with cuff manometer. |
| Intervention |
Intracuff instillation of required volume of 50mg ketamine |
After intubation endotracheal tube cuff filled with required volume of 50mg ketamine diluted with distilled water to maintain the cuff pressure of 20 -25mmHg measured with cuff manometer. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 scheduled for elective surgery |
|
| ExclusionCriteria |
| Details |
1)Patient refusal
2)Already patient on steroids
3)Cardiorespiratory compromise
4)Emergency surgeries
5)Anticipated difficult airway
6)Pregnancy
7)active URTI |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the haemodynamic extubation parameters and incidence and severity of post operative sorethroat |
Haemodynamic parameters 0min,3mins,5mins,10mins
post operative sore throat assesed in 0min,30mins,1 hour,24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Drug effect on postoperative hoarseness and cough. |
Assesed in 0min, 30mins, 1hour,
24hours. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/10/2022 |
| 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
|
not yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endotracheal intra cuff instillation of 2 drugs ketamine and 3%NS after intubation in patients undergoing elective surgery and cuff pressure maintained around 20-25mmHg by using cuff pressure manometer. |