| CTRI Number |
CTRI/2017/03/008105 [Registered on: 15/03/2017] Trial Registered Prospectively |
| Last Modified On: |
13/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of the effect of general anesthesia and spinal anesthesia on a reflex which changes blood pressure |
|
Scientific Title of Study
|
To compare the effect of general anesthesia and subarachnoid block on venous distention reflex |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sree Kumar E J |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra University |
| Address |
59/10 Flat B SBI colony
Adambakkam
Chennai
Chennai
TAMIL NADU
600088
India |
| Phone |
8056564566 |
| Fax |
|
| Email |
sreekumardr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sree Kumar E J |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra University |
| Address |
59/10 Flat B SBI colony
Adambakkam
Chennai
TAMIL NADU
600088
India |
| Phone |
8056564566 |
| Fax |
|
| Email |
sreekumardr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sree Kumar E J |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra University |
| Address |
59/10 Flat B SBI colony
Adambakkam
Chennai
TAMIL NADU
600088
India |
| Phone |
8056564566 |
| Fax |
|
| Email |
sreekumardr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sree Kumar E J |
| Address |
Department of Anesthesiology
Sri Ramachandra University
Porur
Chennai - 600116 |
| 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 |
| Sree Kumar E J |
Sri Ramachandra University |
Department of Anesthesiology
Sri Ramachandra University
Porur
Chennai 600116
Chennai
TAMIL NADU |
8056564566
sreekumardr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Ramachandra university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients coming for elective procedure requiring invasive arterial blood pressure monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Venous distention reflex in subarachnoid block |
Pre and post Subarachnoid block, Venous and arterial systolic, diastolic and mean pressures are noted at
Base line
With tourniquet
After saline infusion (30ml/min for 4 min)
After deflation (for 6 minutes)
|
| Intervention |
venous distention relex in General anesthesia |
Pre and post General anesthesia, Venous and arterial systolic, diastolic and mean pressures are noted at
Base line
With tourniquet
After saline infusion (30ml/min for 4 min)
After deflation (for 6 minutes)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Diabetic patients
2.Hypertensives not on betablockers
3.CKD (not on dialysis)
4.ASA I patients undergoing surgery with Invasive Blood Pressure
|
|
| ExclusionCriteria |
| Details |
1.Refusal of consent
2.Patients on drugs affecting autonomic nervous system
3.Vascular surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in blood pressure by 10 mm Hg |
4 minutes after infusion of saline under tourniquet inflation
1. before anesthesia
2. after anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/05/2017 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a non randomised comparitive study to find the effect of general anesthesia and subarachnoid block on venous distention reflex. Increase in blood pressure following venous
distention through sympathetic activation (Limb venous distension reflex) has been demonstrated in literature. After including patients according to inclusion and exclusion criteria,
peripheral venous access and an arterial line are
obtained and tourniquet is placed. The base line
venous pressure is noted. The tourniquet pressure is kept at 50 mmHg and saline is infused at rate of 30 ml/min for 4 min to distend the veins. The blood pressures are then noted. We postulate that venous distention reflex will not be altered under anesthesia.
|