| CTRI Number |
CTRI/2024/05/067800 [Registered on: 22/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to compare how patients come out of anesthesia after surgery and disability of thinking after coming out of anesthesia after mastoidectomy surgery between opioid and opioid free groups |
|
Scientific Title of Study
|
A comparitive study of opioid free anesthesia with opioid base anesthesia for recovery characteristics and postoperative cognitive dysfunction after mastoidectomy surgeries |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preethi S |
| Designation |
Second year post graduate resident M.D.Anesthesiology |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Room No:A6, Anesthesia Department, Sri Ramachandra Institute Of Higher Education And Research, Ramachandra Nagar, Porur,Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9952155417 |
| Fax |
|
| Email |
preethupree517@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thamarai Selvi |
| Designation |
Professor M.D.Anaesthesiology |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Room No:A6, Anesthesia Department, Sri Ramachandra Institute Of Higher Education And Research, Ramachandra Nagar, Porur,Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841552333 |
| Fax |
|
| Email |
thamarai@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Thamarai Selvi |
| Designation |
Professor M.D.Anaesthesiology |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Room No:A6, Anesthesia Department, Sri Ramachandra Institute Of Higher Education And Research, Ramachandra Nagar, Porur,Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841552333 |
| Fax |
|
| Email |
thamarai@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute Of Higher Education And Research, Porur, Chennai-600116 |
|
|
Primary Sponsor
|
| Name |
Preethi S |
| Address |
Room.no;131,Ladies hostel block- 5,Anesthesia Department,Sri Ramachandra Institute Of Higher Education And Research, Ramachandra Nagar, Porur, Chennai-600116 |
| Type of Sponsor |
Other [Self financing] |
|
|
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 Preethi S |
Sri Ramachandra Institute Of Higher Education And Research |
Department Of Anesthesia, Operating rooms division, Room Number A6
Chennai
TAMIL NADU |
9952155417
preethupree517@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Ramachandra Institute Of Higher Education And Research, Porur, Chennai-600116 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE infusion |
DEXMEDETOMIDINE infusion 1mcgs/kg over 10mins before induction followed by DEXMEDETOMIDINE infusion 0.5mcgs/kg/hr post intubation and continued until before extubation and assessing emergence and extubation time after reversal agent and cognitive function post extubation |
| Comparator Agent |
FENTANYL infusion |
FENTANYL infusion 2mcgs/kg over 10mins before induction followed by FENTANYL infusion 1mcgs/kg/hr
post intubation and continued until before extubation and assessing emergence and extubation time after reversal agent and cognitive function post extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 to 65 years
ASA physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
Taking opioid for chronic pain
Pregnant and nursing women
GCS less than 15 and heart rate less than 50 per min
Allergic to study medications
Psychiatric disorder and electrolyte imbalance
Hepatic and renal insufficiency
Unstable cardiorespiratory disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Emergence time
2)Extubation time
3)recovery of cognitive functions |
1)Emergence time from administration of reversal agent to eye opening
2)Extubation time from adminstration of reversal agent to tracheal extubation
3)recovery of cognitive functions assessed using Short Orientation Memory Concentration test ater extubation at 5, 10 and 15mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Intraoperative hemodynamic stability
2)Postoperative pain assessment |
1)Intraoperatively patient monitored for hemodynamic stability by monitoring heart rate and blood pressure
2)Postoperatively pain was assessed at 2, 6, 12 and 24hours using Numeric rating scale |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Opioid free anesthesia is a technique where no intraoperative opioid is administered during anesthetic management and is usually achieved through sympatholysis, analgesia and anesthesia with DEXMEDETOMIDINE. Because of concern that opioids might cause perioperative respiratory depression, substitution with DEXMEDETOMIDINE will be helpful with analgesic and sympatholytic properties. It can allow for faster awakening and thus an earlier neurological examination by decreasing necessary volatile agent and opioid doses. |