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CTRI Number  CTRI/2023/10/059271 [Registered on: 30/10/2023] Trial Registered Prospectively
Last Modified On: 28/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Dexamethsone on Duration of spinal anesthesia in Cesarean Section Surgeries 
Scientific Title of Study   Effect of two doses of Intravenous Dexamethasone on Duration of Spinal Anesthesia in Lower Segment Cesarean Section Surgeries-A Randomised Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nirali Panchal 
Designation  Professor 
Affiliation  Pramukh Swami Medical College,Bhaikaka University 
Address  Department of Anesthesiology,Pramukh Swami Medical College,Shree krishna Hospital,Karamsad,Anand,Gujarat.

Anand
GUJARAT
388325
India 
Phone  9825031808  
Fax    
Email  dr.niralipanchal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nirali Panchal 
Designation  Professor 
Affiliation  Pramukh Swami Medical College,Bhaikaka University 
Address  Department of Anesthesiology,Pramukh Swami Medical College,Shree krishna Hospital,Karamsad,Anand,Gujarat.


GUJARAT
388325
India 
Phone  9825031808  
Fax    
Email  dr.niralipanchal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Riddhi Patel 
Designation  1st year Resident 
Affiliation  Pramukh Swami Medical College,Bhaikaka University 
Address  Department of Anesthesiology,Pramukh Swami Medical College,Shree krishna Hospital,Karamsad,Anand,Gujarat.

Anand
GUJARAT
3888325
India 
Phone  8160406722  
Fax    
Email  riddhipatel1133@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology,Pramukh Swami Medical College,Shree krishna Hospital,Karamsad,Anand,Gujarat. 
 
Primary Sponsor  
Name  Shree Krishna Hospital 
Address  Shree Krishna Hospital,Karamsad,Anand,Gujarat. 
Type of Sponsor  Private 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 Nirali Panchal  Pramukh Swami medical college,shree Krishna Hospital,Karamsad,Anand  Department of Anesthesiology,Surgical operation theater complex
Anand
GUJARAT 
9825031808

dr.niralipanchal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
H M PATEL CENTRE FOR MEDICAL CARE AND EDUCATION  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 
Comparator Agent  4MG Dexamethasone and 8MG Dexamethasone  Comparison of effect of two single doses of intravenous dexamethasone that is 4mg and 8mg on total duration of sensory block in minutes in spinal anesthesia for about 24 hrs post anesthesia 
Intervention  Effect of Dexamethasone on total duration of spinal anesthesia  Comparison of effect of two single doses of intravenous dexamethasone that is 4mg and 8mg on total duration of sensory block in minutes in spinal anesthesia for about 24 hrs post anesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patient undergoing Lower Segment cesarean section under spinal anesthesia with American Society of Anesthesiologist Physical Status grade||-||| 
 
ExclusionCriteria 
Details  High risk pregnancy-Eclampsia,Preeclampsia,Abruption Placenta,Placenta previa,Cord prolapse,Absolute contraindication to spinal anesthesia,patient on steriod therapy or past history of medication with steriods in last 1 year,Patient with diabetes or gestational diabetes,Allergy to local anesthetic drug 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Will get to know the effect of dexamethasone on duration of spinal anesthesia  15 minutes prior to giving spinal anesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   30/11/2023 
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  

Patients undergoing lower segment caesarean section under spinal anesthesia will be recruited in this study. Pre-anesthetic check up will be carried out in all patients. Participants will be allotted in to two groups through balanced randomization.In group-A patient will receive 4mg intravenous injection dexamethasone and in group-B patient will receive 8mg intravenous injection dexamethasone 15 minutes prior to giving spinal anaesthesia. On arrival to operation theatre, Standard intraoperative monitoring- electrocardiogram, pulse oximetry and noninvasive blood pressure will be attached and baseline vitals will be noted. Under all aseptic precautions spinal anaesthesia will be performed in sitting position at L3-L4 space for lower Segment caesarean section using 23G Quincke spinal needle. After free flow of cerebrospinal fluid, inj. hyperbaric Bupivacaine (0.5%) 10mg will be slowly injected.

Sensory and motor level will be evaluated by blind individual every 30 seconds for first 5 minutes, 1 minute till 10 minutes, every 5 minutes till 30 minutes and every 30 minutes till patients will be in post anesthesia care unit. Sensory block will be checked bilaterally at mid-clavicular line using pinprick method. The onset time of sensory block will be defined as time from drug administration until bilateral T10 level of sensory blockade is achieved. The duration of sensory block will be considered as time from the highest level of sensory blockade until 4 segment regression were observed. Motor block will be checked by Modified Bromage Scale (MBS). The onset time of motor blockage will be defined as time from drug injection until a grade-3 MBS is achieved. The regression of motor block will be considered as the time from full intensity motor blockade until a MBS grade-0 is achieved.

                 Clinically relevant hypotension will be defined as decrease in systolic arterial pressure 20% or more from base line. In that case, Inj. epinephrine 6mg will be given. Bradycardia will be defined as decrease in heart rate to 20% or more from the baseline heart rate. Inj Atropine 0.6mg will be given in such scenarios. Incidence of nausea vomiting will be recorded intraoperatively and will be treated with Inj. Ondensatron 8mg IV. Additional analgesia with Inj.Paracetamol 1gm will be given on visual analougue score(VAS) more than 4. Incidence of peri-operative shivering will be notyed and treated with warming blanket and if not relieved, then by inj.tramadol 25mg iv.

                 For assessing recovary of patient after 24 hr, we will use ObsQoR-11 questionnaries also been translated into gujarati language by forward and backward translation method for easy understanding of patient.The questionnaries will be containing 11 questions to be asked to the patient 24 hrs after cesarean delivery and will be rated according to patients agreement and disagreement.

 
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