| CTRI Number |
CTRI/2021/07/034940 [Registered on: 16/07/2021] Trial Registered Prospectively |
| Last Modified On: |
05/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of effect of menstrual cycle phases on injection pain of propofol |
|
Scientific Title of Study
|
A comparison of the effect of the phases of the menstrual cycle on the injection pain due to propofol and the induction dose of propofol a prospective 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 |
Athira G S |
| Designation |
Post Graduate Student |
| Affiliation |
Karnataka Institute Of Medical Sciences, Hubli |
| Address |
Deoartment Of Anaesthesia, Karnataka Institute Of Medical Sciences, Hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
7012333769 |
| Fax |
|
| Email |
athiragsnayanam01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Madhuri S Kurdi |
| Designation |
Professor |
| Affiliation |
Karnataka Institute Of Medical Sciences, Hubli |
| Address |
Department Of Anaesthesia, Karnataka Institute Of Medical Sciences, Hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
7012333769 |
| Fax |
|
| Email |
sanojmsubramanian@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Athira G S |
| Designation |
Post Graduate Student |
| Affiliation |
Karnataka Institute Of Medical Sciences, Hubli |
| Address |
Department Of Anaesthesia, Karnataka Institute Of Medical Sciences, Hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
7012333769 |
| Fax |
|
| Email |
athiragsnayanam01@gmail.com |
|
|
Source of Monetary or Material Support
|
| KARNATAKA INSTITUTE OF MEDICAL SCIENCES, HUBLI |
|
|
Primary Sponsor
|
| Name |
Dr Athira G S |
| Address |
Post Graduate Student, Department Of Anaesthesiology, Karnataka Institute Of Medical Sciences, Hubli |
| 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 |
| ATHIRA G S |
KIMS HUBLI |
DEPARTMENT OF ANESTHESIA, KIMS, HUBLI,580021
Dharwad
KARNATAKA |
7012333769
athiragsnayanam01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS, HUBLI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Propofol |
Assessing the pain response to propofol injection, dose of 2mg/kg, at a rate of 30 mg over 10 seconds, intravenously |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
ASA I AND II
Patients undergoing elective surgeries under general anesthesia |
|
| ExclusionCriteria |
| Details |
Amenorrhoea
History of oral contraceptive pills
Neurological or psychiatric illness
Difficulty in communication
Difficulty in understanding pain scoring systems
Pregnant or breastfeeding
History of hysterectomy or oophrectomy
Renal or hepatic insufficiency
Patients on analgesic, anti-depressants, sedative drugs
Hypersensitivity to anesthetic drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the effect of different phases of menstrual cycle on pain response to propofol injection |
At the time of propofol injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find whether pain is early or late pain |
To find whether pain within 10 seconds of propofol injection or after 10 seconds. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/09/2021 |
| 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
|
NIL
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to compare the effect of different phases of menstrual cycle on the pain response to propofol injection, to measure and compare the dose requirements of propofol for the induction of general anaesthesia in different phases of menstrual cycle and to find out whether the apin due to propofol injection is early pain ( less than 10 seconds of propofol injection) or late pain ( more than 10 seconds of propofol injection). |