| CTRI Number |
CTRI/2019/03/017897 [Registered on: 01/03/2019] Trial Registered Prospectively |
| Last Modified On: |
28/02/2019 |
| 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
|
Comparing the Intra operative and Post operative effects Dexmedetomidine and Fentanyl used in total intravenous anaesthesia . |
|
Scientific Title of Study
|
Comparison of Propofol-Dexmedetomidine and Propofol-Fentanyl for Total intravenous anaesthesia in minor daycare gynaecological procedures-A Prospective Randomised double blinded study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhumitha Vijay |
| Designation |
Post graduate |
| Affiliation |
Shri Sathya Sai medical college and research centre |
| Address |
Department of Anaesthesia
Room No:13
5th floor
Girls hostel
Sathyasai medical college hospital and research centre
Ammapettai
Kancheepuram
Department of Anaesthesia
Room No:13
5th floor
Girls hostel
Sathyasai medical college hospital and research centre
Ammapettai
Kancheepuram
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
6374076336 |
| Fax |
|
| Email |
madhuvijay195@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPranjali |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai medical college and research centre |
| Address |
C 41
Casa Grande Aldea
Bharathiar nagar main road
Okkiyam
Thoraipakkam
C 41
Casa Grande Aldea
Bharathiar nagar main road
Okkiyam
Thoraipakkam
Chennai
TAMIL NADU
600097
India |
| Phone |
9486414942 |
| Fax |
|
| Email |
pranjalikurhekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Madhumitha Vijay |
| Designation |
Post graduate |
| Affiliation |
Shri Sathya Sai medical college and research centre |
| Address |
Department of Anaesthesia
Room No:13
5th floor
Girls hostel
Sathyasai medical college hospital and research centre
Ammapettai
Kancheepuram
Department of Anaesthesia
Room No:13
5th floor
Girls hostel
Sathyasai medical college hospital and research centre
Ammapettai
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
6374076336 |
| Fax |
|
| Email |
madhuvijay195@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai medical college hospital and research institute
|
|
|
Primary Sponsor
|
| Name |
Dr Madhumitha Vijay |
| Address |
Sathyasai medical college and research institute
Thiruporur-Guduvanchery Main Road
Ammapettai
Nellikuppam
603108 |
| Type of Sponsor |
Other [Self] |
|
|
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 Madhumitha |
Shri Sathya Sai medical college hospital and research institute |
Department of Anaesthesia
Room No:13
5th floor
Girls hostel -SSMCRI
Ammapettai
Kancheepuram
Kancheepuram
TAMIL NADU |
6374076336
madhuvijay195@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
1mcg/kg
Intra venous administration.
Frequency: Once
Duration of therapy: Less than or equal to one hour. |
| Comparator Agent |
Fentanyl |
2mcg/kg
Intravenous administration
Frequency:Once
Duration of therapy:less than or equal to 1 hour. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group from 18 to 60
2.ASA 1 - ASA 2 |
|
| ExclusionCriteria |
| Details |
1. BMI < 18 to > 30
2.Patient with cardiac pathology
3.Known allergy to Propofol, Dexmedetomidine and Fentanyl.
4.Chronic hypertension
5.Patient with cardiac pathology
6.Chronic opioid treatment (Patient receiving sedation or analgesia) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Propofol-Dexmedetomidine versus Propofol-Fentanyl in terms of recovery time. |
Intra operative and Post operative. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time taken for eye opening after last dose of Propofol in both the groups.
To compare the incidence of post operative nausea and vomiting in both the groups.
To compare the haemodynamic stability of the patients in both the groups.
To compare the number of Propofol top ups needed for the patients in both the groups |
Intra operative and Post operative |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
04/03/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Randomised study to compare the efficacy of Propofol-Dexmedetomidine verusus Propofol-Fentanyl in terms of recovery time ,incidence of post operative nausea and vomiting, haemodynamic stability in patients undergoing minor gynaecological procedures.The most commonly used combination for day care anaesthesia is propofol with advantages in of rapid recovery,being held as primary anaesthetic agent for the total intravenous (IV) anaesthesia combined with opioids.Opioids are well known to produce side effects like respiratory depression ,nausea and vomiting and affecting the early recovery,delaying both discharge and return of normalcy for the patient.
Hence this study will be done to evaluate the efficacy of opioids and non opioid agent(Dexmedetomidine) in day care gynaecological procedures. |