CTRI Number |
CTRI/2023/08/056548 [Registered on: 16/08/2023] Trial Registered Prospectively |
Last Modified On: |
15/08/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of haemodynamic parameters following two regimes of fractionated doses of Levobupivacaine in lower segment caesarean section under spinal anaesthesia.
|
Scientific Title of Study
|
Comparative evaluation of haemodynamic parameters following two regimes of fractionated doses of levobupivacaine for spinal anaesthesia in patients of
lower segment caesarean section
-A randomized, comparative, controlled study
|
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Krishna Lakhmani |
Designation |
PG Resident |
Affiliation |
Department of Anaesthesia,School of Medical Sciences and Research and Sharda Hospital |
Address |
Department of Anaesthesia, School of Medical Sciences and Research and Sharda Hospital
Greater Noida ,Gautam Buddha Nagar, Uttar Pradesh 201310 India Greater Noida ,Gautam Buddha Nagar, Uttar Pradesh 201310 India Gautam Buddha Nagar UTTAR PRADESH 201310 India |
Phone |
9839963805 |
Fax |
|
Email |
krishnalakhmani21@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mahendra Kumar |
Designation |
Professor |
Affiliation |
Department of Anaesthesia,School of Medical Sciences and Research and Sharda Hospital |
Address |
Department of Anaesthesia,School of Medical Sciences and Research and Sharda Hospital
Greater Noida ,Gautam Buddha Nagar, Uttar Pradesh 201310 India Greater Noida ,Gautam Buddha Nagar, Uttar Pradesh 201310 India Gautam Buddha Nagar UTTAR PRADESH 201310 India |
Phone |
9839963805 |
Fax |
|
Email |
mahendramohit@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mahendra Kumar |
Designation |
Professor |
Affiliation |
Department of Anaesthesia,School of Medical Sciences and Research and Sharda Hospital |
Address |
Department of Anaesthesia,School of Medical Sciences and Research and Sharda Hospital
Greater Noida ,Gautam Buddha Nagar, Uttar Pradesh 201310 India Greater Noida ,Gautam Buddha Nagar, Uttar Pradesh 201310 India
UTTAR PRADESH 201310 India |
Phone |
9839963805 |
Fax |
|
Email |
mahendramohit@yahoo.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesia,School of Medical Sciences and Research and Sharda Hospital |
|
Primary Sponsor
|
Name |
Department of Anaesthesia,School of Medical Sciences and Research and Sharda Hospital |
Address |
plot no. 32,34,knowledge park 3, Greater Noida ,Gautam Buddha Nagar, Uttar Pradesh 201310 India |
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 |
Dr Krishna Lakhmani |
School of Medical Sciences and Research and Sharda Hospital |
Department of Anaesthesia,
second floor, B block Gautam Buddha Nagar UTTAR PRADESH |
9839963805
krishnalakhmani21@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, School of Medical Sciences and Research,Sharda University, Greater Noida |
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 |
Comparative evaluation of haemodynamic parameters following two regimes of fractionated doses of levobupivacaine for spinal anaesthesia in patients of lower segment caesarean section-A randomized, comparative, controlled study
|
Three groups are taken with a total sample size of 105(35 in each group).The drug Levobupivacaine 0.5% heavy calculated as 0.07 mg/cm of the patient’s height will be given in all three groups in different manner.
Group 1:Total calculated dose of levobupivacaine 0.5% heavy as single bolus dose.
Group 2:Total calculated dose of levobupivacaine 0.5% heavy as two fractionated doses one-third followed by two third with a gap of 90 sec.
Group 3:Total calculated dose of levobupivacaine 0.5% heavy as two fractionated doses two-third followed by one-third with a gap of 90 sec.
Dose-Fractionated
Frequency-one time for spinal anaesthesia
Route of administration -Intrathecal
total Duration-Perioperatively approx 4 hours
|
Comparator Agent |
N/A |
N/A |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
35.00 Year(s) |
Gender |
Female |
Details |
1. Patients scheduled for LSCS under spinal anaesthesia
2. ASA class II
3. Age 18-35 years
4. Height-140-170cms
5. BMI<30kg/m2
6. Uncomplicated singleton pregnancies
7. Patient having systolic blood pressure between 110-130mm of Hg
|
|
ExclusionCriteria |
Details |
1. Patient having history of any systemic illness of cardiovascular system, respiratory system, endocrine, renal or hepatic disorders.
2. Fetal distress (as diagnosed by obstetrician)
3. BMI >30% kg / m2
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To compare the number of patients requiring mephentermine to maintain systolic blood pressure ±20% of baseline value in three groups. (Two groups of fractionated doses & one group of bolus dose).
|
Perioperatively till 2 hours in same setting
|
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare total requirement of mephentermine among three groups
To compare haemodynamic parameters HR SBP DBP MAP
To compare time of onset & regression of sensory & motor block in three
groups
To compare neonatal outcome by APGAR score at 1 min 5 min & 10 min
|
Till 2 hours post operative period |
|
Target Sample Size
|
Total Sample Size="105" Sample Size from India="105"
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 3 |
Date of First Enrollment (India)
|
31/08/2023 |
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 Yet Recruiting |
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 anaesthesia is a commonly practiced anaesthetic
technique in patients undergoing
elective or emergency lower segment caesarean sections. It is a safe, cost
effective and easy to perform technique which provides a denser block and so
more preferred. It also avoids the
various complications of general anaesthesia like stress response, airway
management, post-operative nausea and vomiting and thereby facilitates earlier
resumption of feeding and mobilization. Spinal anaesthesia has a quick onset
and provides satisfactory sensory and motor blockade. Administration of the
appropriate choice and dose of local anaesthetic into the subarachnoid space results in rapid onset of
deep spinal anaesthesia with a greater degree of success .The rapidity of onset
of spinal block is advantageous in cases where delivery of the foetus needs to
be hastened due to compromised fetal
state.1
The required dosage of effective block for LSCS has been
associated with maternal arterial hypotension of 60-90% with maternal and
neonatal morbidity2. The haemodynamic stability and
prolonged duration of analgesia were observed by injecting the local
anaesthetic drug in divided doses into the subarachnoid space.3-5
Spinal anaesthesia(SA) has rapid
onset and is associated with various problems e.g. bradycardia , hypotension .
Maternal hypotension may lead to decrease in uteroplacental perfusion which may
result in fetal acid base imbalance, maternal nausea and vomiting and may be an
important contributory factor for maternal morbidity related to regional
anaesthesia.1 Maternal hypotension and
subsequent consequences are reduced to some extent by various measures like
preloading or coloading of crystalloids or colloids , low dose local
anaesthetic, left uterine displacement, prophylactic use of vasopressors etc
but with reduction in incidence and severity of hypotension..
Several factors like height, weight, pregnancy and
anatomical changes influence the dose of local anaesthetic drug for its intensity and duration of spinal block.
Many physiological and anatomical changes during pregnancy affect spinal
anaesthesia. The hormonal and mechanical factors make pregnant women require
less local anaesthetic than non-pregnant women to attain same level of spinal
anaesthesia.6
Levobupivacaine is an effective long acting amide local
anaesthetic and is an S enantiomer of racemic bupivacaine , since it does not
conatin R isomer , cardiotoxicity and neurotoxicity is lesser than bupivacaine.
In this regard, in addition to above mentioned measures,
fractionated doses of local anaesthetic for spinal anaesthesia has been used to
assess its effect on haemodynamic parameters in caesarean section.
In these studies, a fraction of two-third of calculated
dose of local anaesthetic followed by one-third was used for spinal anaesthesia,
with the incidence of hypotension during spinal anaesthesia in about 16 %
patients as compared to 46% patients who had hypotension with non fractionated
doses (bolus doses).
Extensive search of literature did not show any study
comparing the two fractionated doses (one -third
followed by two-third versus two-third followed by one-third) of local
anaesthetic agent for spinal anaesthesia in the patients of caesarean section.
In the present study, haemodynamic parameters will be
compared in spinal anaesthesia induced with either of two regimes of
fractionated doses (one -third followed by two-third versus two-third followed
by one-third ) or single bolus dose of Levobupivacaine 0.5% Heavy in patients of caesarean section.
|