CTRI Number |
CTRI/2022/04/041979 [Registered on: 20/04/2022] Trial Registered Prospectively |
Last Modified On: |
07/02/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
A study to analyse the effect of intravenous dexamethasone in pregnant females who are undergoing cesarean section under regional Anesthesia through spinal route |
Scientific Title of Study
|
Evaluation of effect of intravenous dexamethasone on the duration of spinal anesthesia in parturients undergoing lower segment cesarean section (LSCS) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr SK Singhal |
Designation |
Senior Professor and Head |
Affiliation |
Pt B D Sharma PGIMS, Rohtak |
Address |
Department of Anaesthesiology and Critical Care
Pt B D Sharma PGIMS, Rohtak
Rohtak HARYANA 124001 India |
Phone |
9416391115 |
Fax |
|
Email |
ssinghal12@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Nitika Goyal |
Designation |
PG Resident |
Affiliation |
Pt B D Sharma PGIMS, Rohtak |
Address |
Department of Anaesthesiology and Critical Care
Pt B D Sharma PGIMS, Rohtak
Rohtak HARYANA 124001 India |
Phone |
9877799572 |
Fax |
|
Email |
nitika.silk@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Nitika Goyal |
Designation |
PG Resident |
Affiliation |
Pt B D Sharma PGIMS, Rohtak |
Address |
Department of Anaesthesiology and Critical Care
Pt B D Sharma PGIMS, Rohtak
Rohtak HARYANA 124001 India |
Phone |
9877799572 |
Fax |
|
Email |
nitika.silk@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology and Critical Care Pt B D Sharma PGIMS Rohtak |
|
Primary Sponsor
|
Name |
Department of Anaesthesiology and Critical Care Pt B D Sharma PGIMS Rohtak |
Address |
Department of Anaesthesiology and Critical Care Pt B D Sharma PGIMS Rohtak |
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 S K Singhal |
Pt. B. D. Sharma Post Graduate Institute of Medical Sciences |
Second floor, New OT cum ICU Complex
Department of Anaesthesiology and Critical Care Rohtak HARYANA |
9416391115
ssinghal12@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Biomedical Research Ethics Committee Pt B D Sharma Post Graduate Institute of Medical Sciences UHS Rohtak |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Intravenous dexamethasone |
To study the effect of intravenous dexamethasone 8 mg diluted with 8 ml normal saline to be given before giving spinal anaesthesia in patients undergoing LSCS under spinal anaesthesia. |
Comparator Agent |
Intravenous normal saline (placebo group) |
To study the effect of intravenous 8 mg dexamethasone as compared to those who are given 10 ml normal saline intravenously before giving spinal anaesthesia in patients undergoing LSCS under spinal anaesthesia |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
35.00 Year(s) |
Gender |
Female |
Details |
Parturients between 20 to 35 years of age belonging to ASA (American Society of Anaesthesiologists) Grade II undergoing Lower Segment Cesarean section (LSCS) under spinal anaesthesia. |
|
ExclusionCriteria |
Details |
1. Patient refusal.
2. Pregnancy induced hypertension.
3. Preexisting hemodynamic instability, preexisting diabetes, cardiac ailment
4. Pre-existing neuropathy or nerve block that could compromise study assessments.
5. Preoperative use of systemic corticosteroids.
6. History of allergy or hypersensitivity to local anaesthetics, dexamethasone or other drugs
used in this study.
7. Any contraindication to spinal anaesthesia (coagulopathy, local infection at the site of
injection).
8.Conversion to general anaesthesia |
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
|
Outcome |
TimePoints |
1. To determine the effect of dexamethasone on the duration of sensory block after spinal
anaesthesia
2. To determine the effect of dexamethasone on the duration of motor block after spinal
anaesthesia. |
Time between spinal anaesthesia and T6 or higher dermatome blockade. Maximum height of the sensory blockade attained at 20 minutes. Time of regression of sensory blockade to L1 dermatome. Time between spinal anaesthesia to Bromage score of III or higher. Maximum degree of motor blockade at 20 min. Time of regression of motor block from peak motor blockade to Bromage score of II. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Duration of post-operative analgesia and complications if any |
Time from the intrathecal injection to the time of
the first complaint of pain. Blood pressure and heart rate will be recorded immediately after spinal anesthesia and then every 5 minutes till the regression of sensory block to L1 and motor block to Bromage score of II. Any episode of hypotension (fall in MAP more than 20% of baseline), bradycardia (heart rate 60 beats /min) will be recorded and managed as per standard protocol |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
28/04/2022 |
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="11" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
This prospective, randomized, double blind placebo controlled study entitled ’Evaluation of
effect of intravenous dexamethasone on the duration of spinal anaesthesia in
parturients undergoing lower segment caesarean section (LSCS)’ will be conducted on parturients between 20 to 35 years of age belonging to ASA (American Society of
Anaesthesiologists) Grade II undergoing Lower Segment Cesarean section (LSCS) under
spinal anaesthesia.
Patients will be randomly allocated by sealed, opaque envelopes- which will not be opened
until patient consent has been obtained into one of the two groups according to a computer generated sequence of random numbers.
Group A: Patients in Group A (n=40) will receive 8 mg (2 ml Dexamethasone + 8ml NS= 10
ml total) Dexamethasone intravenously.
Group B: Patients in Group B (n=40) will receive 10 ml Normal saline intravenously. Drugs used in the study will be prepared by an investigator not involved with patient
enrollment or data collection. All the patients will be positioned by a trained assistant in sitting position. Under all aseptic
precautions, 25 G Quincke’s spinal needle will be inserted intrathecally at L4-L5 or L3-L4
intervertebral space. Intrathecal positioning will be confirmed by observation of clear
cerebrospinal fluid return through the needle. 10 mg (2 ml) of 0.5% Hyperbaric Bupivacaine
will be injected intrathecally. At the end of intrathecal injection, patient will be positioned
supine for surgery. O2 will be administered to the patient via facemask at a flow rate of 4-6
L/min. The level of the sensory and motor blockade will then be evaluated by a blinded
investigator every 2 minutes for the first 10 minutes, then every 5 minutes for the next 20
minutes followed by 15 min interval till the regression of sensory block to L1 and restoration
of motor power to Bromage score II. Sensory blockade will be evaluated with a blunt 22 G
hypodermic needle while motor blockade will be evaluated using Bromage Score. After
completion of surgery patient will be continuously monitored in post-operative area for
regression of sensory blockade to L1 and return of Bromage score to II. If desired level of
spinal block is not achieved, it will be considered as failure of technique, and surgery will
then be conducted under general anaesthesia.
Following observations will be recorded during the study 1.Demographic characteristics such as age (years), height (cm), weight (kg) of all the patients
will be recorded.
2.Sensory block will be assessed by a sterile blunt 22 G hypodermic needle. 2.1 Onset of sensory blockade : The time between intrathecal injection of local anaesthetic
and T6 or higher dermatome blockade as determined by 22 G blunt hypodermic needle tip
will be taken as onset of sensory block. 2.2 Peak sensory level attained: Maximum height of the sensory blockade attained at 20
minutes will be recorded as peak sensory level. 2.3 Duration of stable sensory block: The time of regression of sensory blockade from the
peak sensory level attained at 20 minutes to L1 dermatome will be recorded as duration of
stable sensory block.
3. Motor block will be assessed using Bromage Score. 3.1 Onset of motor blockade: Time between the intrathecal injection of local anesthetic to
Bromage score of III or higher will be taken as onset of motor blockade. 3.2 Peak motor blockade attained: Maximum degree of motor blockade at 20 min will be
recorded as peak motor blockade. 3.3 Duration of motor block: The time of regression of motor block from peak motor
blockade to Bromage score of II will be defined as the duration of motor block.
4.Intraoperative haemodynamic parameters:
Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure
(MAP) and heart rate (HR) will be recorded immediately after spinal anesthesia and then
every 5 minutes till the regression of sensory block to L1 and motor block to Bromage score
of II. Any episode of hypotension (fall in MAP >20 percent of the baseline), bradycardia
(heart rate < 60 beats /min) will be recorded and managed as per standard protocol
5.Duration of post-operative analgesia: Time from the intrathecal injection to the time of
the first complaint of pain will be recorded as duration of analgesia. Rescue analgesia will be
given with paracetamol 1 gm iv. Time of administration of rescue analgesia will be recorded |