| CTRI Number |
CTRI/2014/06/004675 [Registered on: 13/06/2014] Trial Registered Prospectively |
| Last Modified On: |
12/06/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
COMPARISON OF LATERAL AND SITTING POSITIONS DURING SPINAL ANAESTHESIA FOR CESAREAN SECTION |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED TRIAL COMPARING THE EFFECT OF LATERAL AND SITTING POSITIONS DURING SPINAL ANAESTHESIA FOR CESAREAN SECTION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chanderdeep Sharma |
| Designation |
Senior resident |
| Affiliation |
Dr RPGMC Kangra |
| Address |
Dr RP G M C Kangra, Tanda at Kangra (HP)
Tanda at Kangra (HP)
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
919218925471 |
| Fax |
|
| Email |
cdsharma2006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chanderdeep Sharma |
| Designation |
Senior resident |
| Affiliation |
Dr RPGMC Kangra |
| Address |
Dr R P G M C Kangra, Tanda at Kangra (HP)
Tanda at Kangra (HP)
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
919218925471 |
| Fax |
|
| Email |
cdsharma2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chanderdeep Sharma |
| Designation |
Senior resident |
| Affiliation |
Dr RPGMC Kangra |
| Address |
Dr R P G M C Kangra, Tanda at Kangra (HP)
Tanda at Kangra (HP)
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
919218925471 |
| Fax |
|
| Email |
cdsharma2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government of Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Govt of Himachal Pradesh |
| Address |
Dr RPGMC Kangra at Tanda (HP) |
| Type of Sponsor |
Government 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 |
| Chanderdeep Sharma |
Dr RPGMC Kangra at Tanda (HP) |
Department of obstetrics & Gynecology, Dr RPGMC Kangra Tanda (HP)
Kangra
HIMACHAL PRADESH |
9218925471
cdsharma2006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr RPGMC Instituional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
pregnant Women for cesarean section, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SPINAL ANAESTHESIA IN SITTING POSITION |
WOMEN FOR CESAREAN SECTION WILL BE RANDOMIZED TO RECEIVE SPINAL ANAESTHESIA IN SITTING POSITION AS PER HARTENS DOSE CHART |
| Comparator Agent |
spinal anaesthesia in supine position |
women for cesarean section to receive spinal anaesthesia in supine position as per Hartens dose chart |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
• Singleton pregnancy
• Age 18-45 years
• Woman for cesarean section as per obstetrical indication
• Period of gestation between 36 to 41 weeks
|
|
| ExclusionCriteria |
| Details |
• twin pregnancy
• severe pre-eclampsia/ HELLP syndrome
• Co-agulopathy
• Abruptio placentae
• Intra-uterine fetal death/Malformed fetus
• Uncontrolled diabetes mellitus
• Chorio-amniotis
• Known case of thrombophilia
• Known case of chronic Renal or liver disease
• previous classical caesarean section/ hysterotomy
• previous uterine surgery other than caesarean section (myomectomy, hysterotomy, polypectomy, lysis of uterine synechia, or hysteroscopic metroplasty)
• women who do not achieve sensory level T6 or Bromage score 3, 15 minutes after intrathecal injection
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is comparison of fall in blood pressure in two groups. |
from intra-thecal injection to two hours after completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Lowest recorded systolic BP
• Lowest recorded Mean Arterial Pressure (MAP)
• Onset of hypotension (20% fall in systolic BP or 90 mm Hg)
• Use of phenylephrine
• Upper sensory level
• Time to achieve sensory level T6
|
from intra-thecal injection to two hours after completion of surgery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/07/2014 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A total of 100 pregnant women for cesarean section as per obstetrical indication will be randomized to receive spinal anaesthesia in sitting and supine positions. These two groups will be compared with respect to fall in BP, duration of analgesia, lowest BP recordable, blood loss, onset of analgesia, to determine which of the two techniques for spinal anaesthesia, is more effective. |