| CTRI Number |
CTRI/2018/03/012602 [Registered on: 15/03/2018] Trial Registered Prospectively |
| Last Modified On: |
12/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE EFFECTS OF HYPERBARIC BUPIVACAINE AND FENTANYL DRUGS GIVEN EITHER AS A MIXTURE OR SEQUENTIALLY FOR SPINAL ANAESTHESIA IN PATIENTS UNDERGOING CAESAREAN SECTION |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF HYPERBARIC BUPIVACAINE AND FENTANYL GIVEN EITHER AS A MIXTURE OR SEQUENTIALLY FOR SUBARACHNOID BLOCK IN PATIENTS UNDERGOING CAESAREAN SECTION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2017048 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Kalshan |
| Designation |
Post Graduate Student |
| Affiliation |
Vardhman Mahavir Medical College |
| Address |
Department of Anaesthesiology and intensive care,Ground floor,Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi 110029
South West
DELHI
110029
India |
| Phone |
8010886902 |
| Fax |
|
| Email |
rahul.kalshans@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranju Gandhi |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College |
| Address |
Department of Anaesthesiology and intensive care,Ground floor,Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi 110029
South West
DELHI
110029
India |
| Phone |
9818941341 |
| Fax |
|
| Email |
icu_era@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Kalshan |
| Designation |
Post Graduate Student |
| Affiliation |
Vardhman Mahavir Medical College |
| Address |
Department of Anaesthesiology and intensive care,Ground floor,Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi 110029
Department of Anaesthesiology and intensive care,Ground floor,Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi 110029
South West
DELHI
110029
India |
| Phone |
9818941341 |
| Fax |
|
| Email |
rahul.kalshans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi 110029 INDIA |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College |
| Address |
Ansari Nagar, New Delhi
110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ranju Gandhi |
Ansari Nagar, New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul Kalshan |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029 |
Department of Anaesthesiology and intensive care,Ground floor,Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi 110029
South West
DELHI |
8010886902
rahul.kalshans@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Adult ASA I,II parturients with height 145-165 cm and Body mass index 35 kg/m2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mixed group |
Patients in this group will be given 0.5% hyperbaric bupivacaine 9 mg and fentanyl 15 mcg in a 5 ml syringe at a speed of 0.1 ml/sec in the sub arachnoid space by 25 Gauze spinal needle |
| Intervention |
Sequential Group |
Patients in this group will be given 0.5% hyperbaric bupivacaine 9 mg in a 5 ml syringe followed by fentanyl 15 mcg in a 1 ml syringe at a speed of 0.1 ml/sec in the sub arachnoid space by 25 Gauze spinal needle |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Adult ASA physical status I, II with height 145-165 cm and Body mass index (BMI) < 35 kg/m2 |
|
| ExclusionCriteria |
| Details |
Known coagulation abnormality or bleeding diathesis, local infection at the site of spinal injection, raised intracranial tension, chronic hypertension, severe hypotension, hypovolaemia, cord prolapse, hypersensitivity to local anaesthetic or fentanyl. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of hyperbaric bupivacaine and fentanyl given either as a mixture or sequentially for subarachnoid block in terms of 1) Block characteristics, 2) Haemodynamic parameters 3) Time required to achieve sensory block height (T5) for caesarean section. |
Before giving surgical incision |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the duration of sensory and motor block, total dose of vasopressor and neonatal outcome as assessed by Umbilical cord blood gas analysis, Apgar Score and need for Neonatal Resuscitation in above patients |
at the time of giving subarachnoid block, during surgery and post operative period |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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 1 |
|
Date of First Enrollment (India)
|
01/04/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1)Xiao F, Xu WP, Zhang XM, Zhang YF, Wang LZ, Chen XZ. ED 50 and ED 95 of Intrathecal Bupivacaine Coadministered with Sufentanil for Cesarean Delivery Under Combined Spinal-epidural in Severely Preeclamptic Patients. Chin Med J 2015;128:285-90.
2) Desai S, Lim Y, Tan CH, Sia AT. A randomised controlled trial of hyperbaric bupivacaine with opioids, injected as either a mixture or sequentially, for spinal anaesthesia for caesarean section. Anaesth Intensive Care 2010;38:280-4.
3) Keera AA, Elnabtity AM. Two syringe spinal anesthesia technique for cesarean section: A controlled randomized study of a simple way to achieve more satisfactory block and less hypotension. Anesth Essays Res 2016;10:312-8.
4) Sachan P, Kumar N, Sharma JP. Efficacy of premixed versus sequential administration of clonidine as an adjuvant to hyperbaric bupivacaine intrathecally in caesarean section. Anesthesia, Essays and Researches. 2014;8(1):20-5
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
comparison of hyperbaric bupivacaine and fentanyl injected intrathecally either by single syringe or different syringes sequentially . |