| CTRI Number |
CTRI/2020/09/027676 [Registered on: 09/09/2020] Trial Registered Prospectively |
| Last Modified On: |
08/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of the speed of injection of heavy Bupivacaine during spinal anesthesia on the quality of anesthesia and the blood pressure |
|
Scientific Title of Study
|
Effect of injection speed of heavy bupivacaine in spinal anesthesia on quality of block and hemodynamic changes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jerry Paul |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Department of Anesthesiology, Amrita Institute of Medical Sciences, Ponekkara
Department of Anesthesiology, Amrita Institute of Medical Sciences, Ponekkara
Ernakulam
KERALA
682041
India |
| Phone |
9048699161 |
| Fax |
|
| Email |
drjerrypaul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jerry Paul |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Department of Anesthesiology, Amrita Institute of Medical Sciences, Ponekkara
Department of Anesthesiology, Amrita Institute of Medical Sciences, Ponekkara
Ernakulam
KERALA
682041
India |
| Phone |
9048699161 |
| Fax |
|
| Email |
drjerrypaul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Riya Ann Jacob |
| Designation |
Junior Resident |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Department of Anesthesiology, Amrita Institute of Medical Sciences, Ponekkara
Department of Anesthesiology, Amrita Institute of Medical Sciences, Ponekkara
Ernakulam
KERALA
682041
India |
| Phone |
8197180557 |
| Fax |
|
| Email |
rjacob45@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences and Research Centre |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Department of Anesthesiology, Amrita Institute of Medical Sciences, Ponekkara |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Jerry Paul |
Amrita Institute of Medical Sciences |
Anesthesia division for Head and Neck surgery, 1.1 OR complex,
AIMS, Ponekkara, Kochi, PIN 682041
Ernakulam
KERALA |
9048699161
drjerrypaul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Amrita Institure of Medical Sciences |
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 |
| Comparator Agent |
Speed of injection during spinal anesthesia |
injection speed of 15 seconds |
| Intervention |
Speed of injection during spinal anesthesia |
injection speed of 60 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing uncomplicated gynecological surgeries under spinal anesthesia, ASA 1 and 2, Height between 150 165 cm. |
|
| ExclusionCriteria |
| Details |
Hypertensive patients on medication, ischemic heart disease, patients with large intraabdominal mass, patients with ascites. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to achieve T10 dermatome block after spinal anesthesia |
Time to achieve T10 dermatome block after spinal anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hypotension and heart rate change and its onset |
Every 2 minutes for 1st 10 minutes and then every 5 minutes till 1 hour |
|
|
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)
|
15/09/2020 |
| 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="2"
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
|
Speed of injection of drug during spinal anesthesia may have effect on the level of block achieved as well as the onset and degree of hemodynamic changes when a heavy solution of Bupivacaine is used. This study aims to compare the level of blockade achieved and the degree of hemodynamic variations and the onset of such changes if it occurs following the injection of 0.5% Bupivacaine heavy solution at 2 different speeds into the subarachnoid space for spinal anesthesia. The study population is ASA I and ASA II female patients undergoing gynecological surgery under spinal anesthesia and the setting is Amrita Institute of Medical Sciences and Research Centre, Department of Anesthesiology and Critical Care, Kochi.
|