| CTRI Number |
CTRI/2025/01/078873 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| 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
|
Clarification(s) with Reply
Modification(s) A comparison of duration of spinal block in patients posted for elective lower abdomen and lower limb surgeries when the adjuvant is given intravenously, and local anesthetic is given in spine alone. |
|
Scientific Title of Study
|
Intravenous Dexamethasone versus Intravenous Normal Saline in Prolonging the Effect of Spinal Anesthesia in Lower Abdominal and Lower Limb Surgeries Randomized Control Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| . |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Richa Chandra |
| Designation |
Professor |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Room No:- 2062-E Department of Anesthesia Rohilkhand Medical College and Hospital, Philibhit bypass road, Bareilly 243006 UTTAR PRADESH
Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
08279783945 |
| Fax |
|
| Email |
rinkichandra@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. sakshi gupta |
| Designation |
junior resident |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Room No:- 2062-E Department of Anesthesia Rohilkhand Medical College and Hospital, Philibhit bypass road, Bareilly 243006 UTTAR PRADESH
Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8920613842 |
| Fax |
|
| Email |
sakshigupta737@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa Chandra |
| Designation |
Professor |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Room No:- 2062-E Department of Anesthesia Rohilkhand Medical College and Hospital, Philibhit bypass road, Bareilly 243006 UTTAR PRADESH
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
08279783945 |
| Fax |
|
| Email |
rinkichandra@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, 243006, Uttar pradesh, India |
|
|
Primary Sponsor
|
| Name |
Rohilkhand Medical College and Hospital |
| Address |
Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, 243006, Uttar pradesh, 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 Richa Chandra |
Rohilkhand medical College and hospital |
Operation theatre
Room No:- 2062-E Department of Anesthesia Rohilkhand Medical College and Hospital, Philibhit bypass road, Bareilly 243006 UTTAR PRADESH
Bareilly
UTTAR PRADESH
Bareilly
UTTAR PRADESH |
08279783945
rinkichandra@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, RMCH, Bareilly, U.P |
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 |
Dexamethasone |
Patients will be administered intravenous dose of 8mg of dexamethasone immediately after the administration of spinal anesthesia with 3ml of hyperbaric ropivacaine 0.75% |
| Comparator Agent |
normal saline |
Patients will be administered with 2ml of normal saline immediatley after the spinal anesthesia with 3ml of hyperbaric ropivacaine 0.75% |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anesthesiologist (ASA) grade I or II and Patient having elective procedures on lower limbs and abdomen. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal for the procedure
2.Infection at the site
3.Any abnormality of spinal anatomy
4.Allergy or intolerance to regional anesthesia
5.Coagulopathy or Bleeding disorder |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Onset of sensory & motor blockade
2. Highest level of sensory block
3. Time for two segment regression of sensory
block
4. Duration of motor blockade
5. Time for first rescue analgesic
6. Incidence of post-operative nausea, vomiting
and post spinal shivering. |
for sensory blockade the time to assess will be by pin prick sensation every 2min till loss at T06 dermatome and motor till the modified bromage grade 3 occurs.
after the surgery, the time needed for the 1st rescue analgesia will be noted |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic parameters (Heart rate, systolic
and diastolic blood pressure, mean arterial
pressure) |
During the surgery the patient’s pulse rate, Systolic and Diastolic blood pressure, Mean Arterial Pressure, arterial oxygen saturation will be recorded every 3 minutes for 30 minutes and then every 5 minutes until finishing the procedure. In post-operative period parameters will be recorded for every 15 minutes for 45 minutes and then hourly for 2 hours. |
|
|
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)
|
30/01/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 anesthesia has significantly evolved, offering various techniques and adjuvants to enhance efficacy and patient outcomes. Notably, the intravenous dexamethasone as soon as the patient is lied supine after the hyperbaric ropivacaine 3ml given intrathecally is of great interest. This study tells us about the efficacy of the intravenous dexamethasone in prolonging the effect of spinal anesthesia and also how it reduces the need for the post op analgesia.
Hyperbaric ropivacaine produces more reliable motor or sensory blocks with faster onset. Also it has better result as it has less central nervous system toxicity and is more cardio stable has lesser episodes of hypotension.
Dexamethasone is strong and selective glucocorticoid with minimal mineralocorticoid effect. Immunosuppressive properties and anti-inflammatory properties of dexamethasone if given intravenously might be in charge of the analgesic’s prolonged duration postoperatively |