| CTRI Number |
CTRI/2023/08/056780 [Registered on: 22/08/2023] Trial Registered Prospectively |
| Last Modified On: |
21/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Single center Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Preoperative occurrence of positional change in blood pressure in patients with multiple comorbidities and variation in blood pressure while starting anesthesia. |
|
Scientific Title of Study
|
Incidence of orthostatic hypotension among patients with multimorbidity undergoing general anesthesia for elective surgeries and correlation with hemodynamics during induction of general anesthesia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mansi Madhup Singh |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and Hospital Manipal |
| Address |
Department of Anaesthesiology
Kasturba Medical College and Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9695372276 |
| Fax |
|
| Email |
mansi.kmcmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha Sara M Jacob |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College and Hospital Manipal |
| Address |
Department of Anaesthesiology
Kasturba Medical College and Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9500574751 |
| Fax |
|
| Email |
nishasara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha Sara M Jacob |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College and Hospital Manipal |
| Address |
Department of Anaesthesiology
Kasturba Medical College and Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9500574751 |
| Fax |
|
| Email |
nishasara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Manipal , Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Mansi Madhup Singh |
| Address |
Department of Anaesthesiology Kasturba Medical College and Hospital Manipal 576104 |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Nisha Sara M Jacob |
Department of Anaesthesiology Kasturba Medical College and Hospital Manipal 576104 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mansi Madhup Singh |
Kasturba Medical College and Hospital |
Main Operation Theatre complex
Department of Anaesthesiology
Udupi
KARNATAKA |
9695372276
mansi.kmcmpl@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (2) ICD-10 Condition: C00-D49||Neoplasms, (3) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, (4) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (5) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, (6) ICD-10 Condition: G00-G99||Diseases of the nervous system, (7) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (8) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (9) ICD-10 Condition: K00-K95||Diseases of the digestive system, (10) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, (11) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (12) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, (13) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgery under general anesthesia
Adult patients above 18 years of age and Body mass index 20-30 kilogram per meter square |
|
| ExclusionCriteria |
| Details |
Patients undergoing lower limb surgeries and unable to ambulate
Patients who are unable to ambulate
Patients included in other studies
Patients with arteriovenous fistula
Patients with abnormalities of upper limb that preclude use of blood pressure cuff
Patients planned for cardiac and neurosurgical procedures
Pregnant patients |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Preoperative orthostatic hypotension defined as fall in Systolic blood pressure by 20 mm of Hg or Diastolic blood pressure by 10 mm of Hg 3 minutes after active standing from rested supine position |
At 30 seconds
At 3 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post induction hypotension defined as fall in Mean blood pressure by more than 20 percent from baseline following induction of general anesthesia |
At 30 seconds
At 1 minute
At 2 minutes
At 3 minutes
At 4 minutes
At 5 minutes
At 10 minutes
At 15 minutes
At subsequent intervention |
|
|
Target Sample Size
|
Total Sample Size="385"
Sample Size from India="385"
Final Enrollment numbers achieved (Total)= "385"
Final Enrollment numbers achieved (India)="385" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/08/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
06/03/2025 |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Incidence of orthostatic hypotension among patients with multiple comorbidities during pre operative evaluation and correlation with hemodynamic parameters during induction of general anesthesia to aid in better management of intraoperative hypotension. |