| CTRI Number |
CTRI/2018/02/012111 [Registered on: 23/02/2018] Trial Registered Prospectively |
| Last Modified On: |
16/02/2018 |
| 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 difference between pre-decided dose and calculated dose as per height of patient for the drug 0.5% bupivacaine injected around the spinal cord for anaesthesia in patients for casearean delivery |
|
Scientific Title of Study
|
Comparison of height adjusted dose versus fixed dose of 0.5% hyperbaric bupivacaine in spinal anaesthesia for caesarean delivery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay Kumar |
| Designation |
Senior Specialist |
| Affiliation |
Deen Dayal Upadhyay Hospital, Govt. of NCT of Delhi |
| Address |
Department of Anaesthesiology & Critical Care, DeenDayal Upadhyay Hospital, Govt. of Delhi
New Delhi
DELHI
110064
India |
| Phone |
9718990114 |
| Fax |
|
| Email |
ajayannu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Senior Specialist |
| Affiliation |
Deen Dayal Upadhyay Hospital, Govt. of NCT of Delhi |
| Address |
Department of Anaesthesiology & Critical Care, DeenDayal Upadhyay Hospital, Govt. of Delhi
New Delhi
DELHI
110064
India |
| Phone |
9718990114 |
| Fax |
|
| Email |
ajayannu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satishkumar Mandve |
| Designation |
Post Graduate Student |
| Affiliation |
Deen Dayal Upadhyay Hospital, Govt. of NCT of Delhi |
| Address |
Department of Anaesthesiology & Critical Care, DeenDayal Upadhyay Hospital, Govt. of Delhi
West
DELHI
110064
India |
| Phone |
9967112492 |
| Fax |
|
| Email |
drsatishmandve@yahoo.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Deen Dayal Upadhyay Hospital |
| Address |
Department of Anaesthesiology and Critical care, DeenDayal Upadhyay Hospital, Hari Nagar, New Delhi- 110064 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ajay Kumar |
Deen Dayal Upadhyay Hospital, Govt of NCT of delhi |
Obstetrics and Gynaecology OT, First floor,
Department of Anaesthesiology and Critical Care
West
DELHI |
9718990114
ajayannu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee, Deen Dayal Upadhyay Hospital, Hari Nagar, Delhi-110064, Govt of NCT of Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pregnant patients for casearean section under spinal anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fixed dose |
Patients in this group will receive 2 ml (10mg) of 0.5% bupivacaine heavy with 10µg fentanyl in spinal anaesthesia |
| Intervention |
Height adjusted dose |
Patients in this group will receive height adjusted dose (0.06 mg/ cm height) of 0.5% bupivacaine heavywith 10µg fentanyl in spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anesthesiologists physical status I or II women with term pregnancy (> 37 weeks gestation), with singleton pregnancy, with Height between 140 cm to 170 cm (both values inclusive) and Weight between 40 kg to 90 kg (both values inclusive)
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Pre-existing or pregnancy induced hypertension
3.Diabetes Mellitus, cardiovascular or cerebrovascular disease
4.Spine deformities or history of spine surgery
5.Foetal abnormality, fetal distress, complicated pregnancy
6.Allergy to any study medication
7.Absolute or relative contraindication to spinal anaesthesia
|
|
|
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 compare the incidence of hypotension, in parturients receiving height adjusted dose and fixed dose of 0.5% hyperbaric bupivacaine under spinal anaesthesia for caesarean delivery |
injection of spinal anaesthetic drug till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sensory block characteristics |
injection of spinal anaesthetic drug till regression of sensory block to S2 dermatome. |
Motor block characteristics
|
injection of spinal anaesthetic drug till complete motor (muscle power)recovery |
| Total dose of Injection mephentermine used to treat hypotension |
injection of spinal anaesthetic drug till complete motor (muscle power)recovery |
| Incidence of bradycardia, nausea, vomiting |
injection of spinal anaesthetic drug till complete motor (muscle power)recovery |
| Neonatal outcome (Apgar score) |
Apgar score at 1 minute and 5 minute post delivery of baby |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2018 |
| 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="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This prospective, randomized, comparative, double-blind study will be conducted after obtaining approval from the Institutional Ethical and Scientific Committee of Deen Dayal Upadhyay Hospital and written informed consent of patients. One hundred and ten patients fulfilling the inclusion criteria, scheduled for elective or emergency caesarean delivery under spinal anaesthesia, will be enrolled in the study. Patients will be allocated to one of the two study groups after randomization. Patients in Group H will receive height adjusted dose (0.06 mg/ cm height) of 0.5% bupivacaine heavy with 10µg fentanyl and patients in Group F will receive 2 ml (10mg) of 0.5% bupivacaine heavy with 10µg fentanyl for spinal anaesthesia. Following study drug injection, the incidence of hypotension,dose of inj. mephentermine used, sensory and motor block characteristics, incidence of complications such as bradycardia, nausea and vomiting and neonatal outcome (Apgar score) will be compared in the two groups. |