| 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
|
|
|
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
|
|
|
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. |