| CTRI Number |
CTRI/2016/05/006931 [Registered on: 13/05/2016] Trial Registered Retrospectively |
| Last Modified On: |
11/05/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare the effect of magnesium sulphate and/or fentanyl added to intrathecal bupivacaine on Blood Pressure, Heart Rate and post operative Pain in elective caserean section. |
|
Scientific Title of Study
|
To compare the effect of magnesium sulphate and/or fentanyl added to intrathecal bupivacaine on haemodynamics and post operative analgesia in parturients undergoing elective 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 |
Dr Yuvraj Singh |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. RPGMC Kangra at Tanda |
| Address |
Room No 106, Satluj Boys Hostel, Dr. Rajendera Prasad Govt Medical College Kangra at Tanda. H.P
Room No 106, Satluj Boys Hostel, Dr. Rajendera Prasad Govt Medical College Kangra at Tanda. H.P
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
7831977366 |
| Fax |
|
| Email |
dryuvraj18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yuvraj Singh |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. RPGMC Kangra at Tanda |
| Address |
Room No 106, Satluj Boys Hostel, Dr. Rajendra Prasad Govt. Medical College Kangra at Tanda. H.P
Room No 106, Satluj Boys Hostel, Dr. Rajendra Prasad Govt. Medical College Kangra at Tanda. H.P
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
7831977366 |
| Fax |
|
| Email |
dryuvraj18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shelly Rana |
| Designation |
Associate Professor |
| Affiliation |
Dr. RPGMC Kangra at Tanda |
| Address |
Associate Professor, Deptt. of Anaesthesia, Dr. Rajendra Prasad Govt. Medical College Kangra at Tanda. H.P
Associate Professor, Deptt. of Anaesthesia, Dr. Rajendra Prasad Govt. Medical College Kangra at Tanda. H.P
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
919418113786 |
| Fax |
|
| Email |
shelkbj@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr. Rajendra Prasad Govt. Medical College Kangra at Tanda. H.P |
|
|
Primary Sponsor
|
| Name |
Dr RPGMC Kangra at Tanda |
| Address |
Dr. Rajendra Prasad Govt. Medical College Kangra at Tanda. H.P |
| 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 |
| Dr Yuvraj Singh |
Dr RPGMC Kangra at Tanda H.P |
Deptt of anaesthesia, Dr RPGMC Kangra at Tanda HP
Kangra
HIMACHAL PRADESH |
7831977366
dryuvraj18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Dr. RPGMC Kangra at Tanda, HP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA 1and 2 Parturient undergoing Elective LSCS , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
fentanyl and Magnesium Sulfate with Bupivacaine |
To compare the synergistic effects of magnesium sulphate and/or fentanyl with bupivacaine 0.5% (H) on hemodynamics , quality and duration of postoperative analgesia in parturient undergoing elective caesarean section under subarachnoid block. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.parturients undergoing elective cesarean section
2.ASA class 1-2
3.BMI <40 |
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal for consent.
2. Patients having bleeding disorders, thrombocytopenia
3. Local infection at the site where needle for block is to be inserted.
4. Allergic to study drugs.
5. Pregnancy induced hypertension, HELLP syndrome
6. Anemia
7. Patients in whom the block effect will be partial and will require supplementary anesthesia.
8. Parturient is on magnesium therapy
9. Fetal distress |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| time of 1st resuce Analgesia |
time of 1st resuce Analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hemodynamic stability beginning of sensory and motor block time to maximal sensory block duration of sensory motor block use of vasopressor and demand of rescue analgesia |
from 0 to 24 hrs post operatively |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/04/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare
the synergistic effects of magnesium sulphate and/or fentanyl with bupivacaine 0.5%
(H) on hemodynamics , quality and duration of postoperative analgesia in parturient
undergoing elective caesarean section under subarachnoid block.
|