| CTRI Number |
CTRI/2026/02/103964 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of effects of general anaesthesia on heart in premenopausal and postmenopausal women |
|
Scientific Title of Study
|
Comparison of Perioperative Cardiovascular Responses to General Anaesthesia in Premenopausal and Postmenopausal Women undergoing general anaesthesia: A Prospective Observational pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
A Chaitanya Pratyusha |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Bibinagar |
| Address |
Faculty room, near OT, Admin block, AIIMS Bibinagar, Rangapur Village, Bibinagar Mandal,Yadadri Bhuvanagiri Distrcit
Nalgonda
TELANGANA
508126
India |
| Phone |
9063571725 |
| Fax |
|
| Email |
chaitanyapa9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A Chaitanya Pratyusha |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Bibinagar |
| Address |
Faculty room, near OT, Admin block, AIIMS Bibinagar, Rangapur Village, Bibinagar Mandal,Yadadri Bhuvanagiri Distrcit
Nalgonda
TELANGANA
508126
India |
| Phone |
9063571725 |
| Fax |
|
| Email |
chaitanyapa9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
A Chaitanya Pratyusha |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Bibinagar |
| Address |
Faculty room, near OT, Admin block, AIIMS Bibinagar, Rangapur Village, Bibinagar Mandal,Yadadri Bhuvanagiri Distrcit
Nalgonda
TELANGANA
508126
India |
| Phone |
9063571725 |
| Fax |
|
| Email |
chaitanyapa9@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Faculty room, near OT, Admin block, AIIMS Bibinagar, Rangapur Village, Bibinagar mandal, Yadadri Bhuvanagiri district, Telangana, India, 508126 |
| Type of Sponsor |
Other [Dr A Chaitanya Pratyusha] |
|
|
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 A Chaitanya Pratyusha |
All India Institute of Medical Sciences, Bibinagar |
Operation theatre, Department of anaesthesia, Admin block
Nalgonda
TELANGANA |
9063571725
chaitanyapa9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS BBN-IEC |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Female patients aged 18 to 75 years
Undergoing general anaesthesia
ASA physical status I and II
|
|
| ExclusionCriteria |
| Details |
Known cardiovascular disease (ischemic heart disease, heart failure, arrhythmias)
Uncontrolled Hypertension
Diabetes mellitus with autonomic neuropathy
Hormone replacement therapy
BMI >30 kg/m²
Emergency surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare mean arterial pressure (MAP) changes between premenopausal and postmenopausal women during induction. |
Immediately after induction of general anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare mean arterial pressure (MAP) changes between premenopausal & postmenopausal women during intubation, & maintenance of anaesthesia
2. To compare heart rate (HR) changes between premenopausal & postmenopausal women during induction, intubation, & maintenance of anaesthesia
3. To evaluate differences in heart rate variability (HRV) parameters between the two groups during induction, intubation, & maintenance of anaesthesia
4. To compare vasopressor requirements between premenopausal & postmenopausal women
|
Baseline, 1 minute after intubation with endotracheal tube & once in every 15 minutes in the intraoperative period
|
|
|
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)
|
01/03/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
|