| CTRI Number |
CTRI/2025/03/083531 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| 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
|
A study which compares the effect of spinal anesthesia drug in human body when given as bolus and when given as fractions in patients undergoing planned cesarean section |
|
Scientific Title of Study
|
Comparison of fractionated dose versus bolus
dose injection in spinal anaesthesia for patients undergoing elective caesarean section |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
venkat Prabu P |
| Designation |
PG RESIDENT |
| Affiliation |
Chettinad Hospital and Research Insitute |
| Address |
Department of Anesthesiology Chettinad Academy of Research and Education Rajiv Gandhi salai Kelambakkam
Kancheepuram district
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
6381702566 |
| Fax |
|
| Email |
venkatprabu2427@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand S |
| Designation |
Professor |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of anesthesiology
Chettinad Academy of Research and Education
Rajiv Gandhi salai
Kelambakkam
Kancheepuram district
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9444486183 |
| Fax |
|
| Email |
dranandmurugan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand S |
| Designation |
Professor |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of anesthesiology
Chettinad Academy of Research and Education
Rajiv Gandhi salai
Kelambakkam
Kancheepuram district
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9444486183 |
| Fax |
|
| Email |
dranandmurugan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital and Research Institute Rajiv Gandhi salai Kelambakkam Kancheepuram district
Tamilnadu
603103
India |
|
|
Primary Sponsor
|
| Name |
Chettinad Hospital and Research Institute |
| Address |
Chettinad health city, 1st Floor, D block, Old Mahabalipuram Road Kelambakkam Pin code 603103 |
| 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 |
| Venkatprabu P |
Chettinad Academy of Research and Education |
Department of Anesthesiology, D block, 1st Floor, Chettinad Academy of Research and Education, Chettinad Health city, Rajiv Gandhi Salai, Kelambakkam, Kancheepuram district Tamil Nadu
India
Kancheepuram
TAMIL NADU |
6381702566
venkatprabu2427@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research (CARE IHEC-1) |
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 |
Group A - Bolus dose |
Patients who are undergoing elective cesarean section will receive a single bolus dose of levobupivacaine with buprenorphine intrathecally over 10 seconds and will be monitored intraoperatively and postoperatively .
|
| Comparator Agent |
Group B - Fractionated dose |
Patients who are undergoing elective cesarean section will receive fractionated dose of levobupivacaine with buprenorphine intrathecally with two-third of the total calculated dose given initially followed by one-third dose after 90 seconds and will be monitored intraoperatively and postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anesthesiologists physical status I and II, age from 18 to 40 years, height
from 150 to 170 cm, pregnancies scheduled for elective Lower Segment Caesarean Section under Spinal anaesthesia
|
|
| ExclusionCriteria |
| Details |
Pre-existing diseases
Pregnancy-induced hypertension
Cardiovascular disease
Cerebrovascular disease
Any contraindication to Spinal anaesthesia
Weight less than 50 kg or more than 110 kg
Height less than 150 cm
Severely altered mental status
Spine deformities
History of laminectomy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the hemodynamic stability in fractionated dose versus bolus dose in spinal Anaesthesia for patients undergoing elective lower segment caesarean section (LSCS).
|
First 6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare duration of analgesia and to compare the sensory and motor block characteristics
|
First 6 hours |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="0"
Months="2"
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
|
Spinal anesthesia has a rapid onset but at the same time, it precipitates hypotension. The incidence of hypotension is reported to be 92%–94% when no preventive measures are taken. Bolus dose of the local anesthetic agent in Spinal anesthesia causes more hypotension. The fractionated dose of the local anesthetic agent, in which two-third of the total calculated dose given initially followed by one-third dose after a time gap of 90 s, achieves adequate spinal anesthesia and provides a dense block with hemodynamic stability
The study will be used to compare the hemodynamic stability, duration of analgesia and the characteristics of sensory and motor blockade in fractionated dose versus bolus dose in spinal Anesthesia for patients undergoing elective lower segment caesarean section.
|