| CTRI Number |
CTRI/2022/05/042386 [Registered on: 05/05/2022] Trial Registered Prospectively |
| Last Modified On: |
12/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of two drugs for spinal anaesthesia in patients of older age group undergoing short urological procedures |
|
Scientific Title of Study
|
Spinal block with 0.75% Ropivacaine heavy versus 0.5% Bupivacaine heavy for short urological procedures in elderly population: A Randomized, Comparative and Controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIDHI ARUN |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of medical sciences Patna |
| Address |
E/302, Jalalpur Heights
Mansarovar Colony
RPS More
Dept. of Anaesthesiology, IGIMS, Shekhpura, Patna, Bihar
Patna
BIHAR
801503
India |
| Phone |
09523594059 |
| Fax |
|
| Email |
janya.mukesh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NIDHI ARUN |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of medical sciences Patna |
| Address |
E/302, Jalalpur Heights
Mansarovar Colony
RPS More
Dept. of Anaesthesiology, IGIMS, Shekhpura, Patna, Bihar
Patna
BIHAR
801503
India |
| Phone |
09523594059 |
| Fax |
|
| Email |
janya.mukesh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
NIDHI ARUN |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of medical sciences Patna |
| Address |
E/302, Jalalpur Heights
Mansarovar Colony
RPS More
Dept. of Anaesthesiology, IGIMS, Shekhpura, Patna, Bihar
Patna
BIHAR
801503
India |
| Phone |
09523594059 |
| Fax |
|
| Email |
janya.mukesh@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nidhi Arun |
| Address |
IGIMS, Patna |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Nidhi Arun |
Indira Gandhi Institute of Medical Sciences |
Dept. of Anaesthesiology, 1st floor, Ward block, IGIMS, Shekhpura
Patna
BIHAR |
9523594059
janya.mukesh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IGIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SAB with 0.5% Bupivacaine |
Characteristic and duration of spinal block, recovery time, height of sensory block, time of first micturation |
| Comparator Agent |
SAB with 0.75% Ropivacaine heavy |
Characteristic and duration of spinal block, recovery time, height of sensory block, time of first micturation |
| Intervention |
SAB with study drugs |
Under all aseptic precautions, Lumber puncture will be done in L3 – L4 or L4-L5 interspace with 25 gauge Quincke spinal needle in sitting position. After confirming free, clear and continuous flow of cerebrospinal fluid, intrathecal administration of drugs will be done as follows -
1. Group R- Patients will receive SAB with 3 ml of 0.75% hyperbaric Ropivacaine , and
2. Group B- Patients will receive SAB with 3 ml of 0.5% hyperbaric Bupivacaine
Patients will be turned immediately on their back and sensory analgesia will be assessed by pinprick at every two minutes interval up to 30 minutes. After achieving the adequate level of anaesthesia up to 10th thoracic dermatome, surgeons will be allowed to operate. All patients will receive adequate intravenous fluids. Any hypotension (30% fall from basal blood pressure) will be treated with injection Mephentermine 6 mg IV and with loading Ringer lactate solution. Bradycardia (pulse rate below 50 beat / minute) will be treated with injection Atropine 0.6 mg IV.
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age ≥50 years
2. ASA Grade-I & II
3. Undergoing short urological procedures under SAB
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. ASA Grade-III & IV
3. Unstable hemodynamic status
4. Allergic to study agents
5. Any contraindication to SAB
6. Coagulopathy
• Prolonged urological procedures requiring conversion to general anaesthesia or any anaesthetic supplementation
• Mental disorders, such as schizophrenia and psychosis on long-term psychotropic drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Time of onset of sensory block (minutes)
2. Maximum cephalic spread (dermatome)
3. Time to maximum cephalic spread (minutes)
4. Two segment regression time (minutes)
7. Total duration of sensory block (minutes)
8. Degree of block assessed by Bromage scale
9. Intra-operative vital parameters |
After the spinal block is given and during the surgical procedure at 15 minutes interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. In recovery room pulse rate, blood pressure, respiratory rate and SPO2 will be monitored
2. Time of need of analgesia by patients
3. First time of micturition after the procedure
|
After the procedure in recovery room, at arrival,and then at 15, 30, 45, and 60 minutes |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/05/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Not yet
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
0.5% Bupivacaine has been widely used for spinal anaesthesia. However, it is associated with various side effects like, prolonged motor blockade, urinary retention, cardio-vascular as well as central nervous system toxicity due to its high lipid solubility. Short length of carbon chain makes ropivacaine less lipid soluble. Being less lipophilic, Ropivacaine has less cardio-toxicity and more selective sensory versus motor toxicity. With this background we are undertaking this study to verify the beneficial properties of hyperbaric ropivacaine in elderly patients posted for short urological procedures under spinal block. |