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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
 
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