| CTRI Number |
CTRI/2024/11/076498 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Two drug comparison of low dose of Ropivacaine with Fentanyl and low dose Bupivacaine with Fentanyl which will be givengiven via spinal anesthesia to know which drug combination is better in anesthetizing the required surgical area and cause less side effects in Transurethral surgery of prostate. |
|
Scientific Title of Study
|
Comparative evaluation of low dose ropivacaine with fentanyl and low dose bupivacaine with fentanyl in subarachnoid block in TURP. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajay Singh Bhardwaj |
| Designation |
Secondary DNB resident |
| Affiliation |
NDMC medical college and Hindu rao hospital |
| Address |
Department of Anaesthesiology and Critical Care.
Hindu Rao Hospital
Department of Anaesthesiology and Critical care,
HIndu Rao Hospital
North
DELHI
110007
India |
| Phone |
9911198585 |
| Fax |
|
| Email |
ajbhardwaj85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kumar Gupta |
| Designation |
Senior Consultant (Anaesthesiology) and CMO (SAG) |
| Affiliation |
HINDU RAO HOSPITAL AND NDMC MEDICAL COLLEGE |
| Address |
Department of Anaesthesiology, Hindu Rao Hospital and NDMC Medical College,Malkaganj,
Delhi-110007
North
DELHI
110007
India |
| Phone |
9810655949 |
| Fax |
|
| Email |
drskgupta4u@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Kumar Gupta |
| Designation |
Senior Consultant (Anaesthesiology) and CMO (SAG) |
| Affiliation |
HINDU RAO HOSPITAL AND NDMC MEDICAL COLLEGE |
| Address |
Department of Anaesthesiology, Hindu Rao Hospital and NDMC Medical College,Malkaganj
North
DELHI
110007
India |
| Phone |
9810655949 |
| Fax |
|
| Email |
drskgupta4u@gmail.com |
|
|
Source of Monetary or Material Support
|
| HINDU RAO HOSPITAL AND NDMC MEDICAL COLLEGE, MALKAGANJ, DELHI-1100007 |
|
|
Primary Sponsor
|
| Name |
HINDU RAO HOSPITAL AND NDMC MEDICAL COLLEGE |
| Address |
HINDU RAO HOSPITAL AND NDMC MEDICAL COLLEGE,
MALKAGANJ,
DELHI-110007 |
| Type of Sponsor |
Government 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 SANJAY KUMAR GUPTA |
NDMC Medical College and Hindu Rao Hospital |
Department of Anesthesiology and Critical Care.
North
DELHI |
9810655949
drskgupta4u@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,north dmc medical college and hindu rao hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA 1 AND ASA 2 PATIENTS ONLY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A comparative analysis of low-dose ropivacaine with fentanyl versus low-dose bupivacaine with fentanyl for subarachnoid block during transurethral resection of the prostate. |
To compare the efficacy of low dose bupivacaine with fentanyl and low dose ropivacaine with fentanyl in terms of duration of sensory blockade. |
| Comparator Agent |
Bupivacaine (heavy) with fentanyl- Group B
versus
Ropivacaine (heavy) with Fentanyl -Group R |
GROUP B- will receive intrathecal 5mg of 0.5% hyperbaric Bupivacaine ( 1 ml) with 25 mcg of Fentanyl (0.5mg)
GROUP R- will receive intrathecal 7.5mg of 0.75% hyperbaric Ropivacaine ( 1ml) with 25mcg of Fentanyl ( 0.5ml) |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1. Patients aged 40-80 years undergoing TURP.
2. Patients classified as American Society of Anesthesiologists (ASA) grade I and II.
3. Patients weighing between 40-80 kilograms.
4. Patients with a height ranging from 150 to 180 centimeters. |
|
| ExclusionCriteria |
| Details |
1. Refusal to participate in the study.
2. Known allergy to any drugs used in the study.
3. Presence of spinal deformity or focal neurological deficits.
4. Infection at the proposed site of subarachnoid block.
5. Body Mass Index (BMI) greater than 40.
6. Contraindications to subarachnoid block.
7. Coagulation disorders, inability to understand the Visual Analogue Scale (VAS), or prostate weight exceeding 70 grams.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• INTRA OPERATIVE:
1.Onset Time to T10 level of sensory block.
2.Time to maximum sensory and maximum motor block level.
3.Total duration of sensory and motor block.
• POST OPERATIVE:
1. Time to first analgesic requirement will be evaluated and recorded.
2. Regression of motor block using modified bromage score.
3.Post operative pain (using visual analogue scale 0-10).
4.Time to discharge(decided by the Modified Aldrete Scoring system).
|
BLOCK characteristics(sensory and motor block) and haemodynamic parameters will be checked at-0 mins, 1 mins, 3mins, 5mins, 10mins, 15mins, 20 mins and every 10 minutes till patient is shifted to recovery room.
From arrival in PACU ( parameter to be checked are- SBP, DBP, Sensory block , Motor block , VAS score , Modified Aldrete score)- 0min, 15 min, 30 min, 45min, and every 15 min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• SECONDARY OBJECTIVES:
1.To compare onset time to T10 level of sensory block in both the groups.
2.To compare time to maximum sensory block level in both the groups.
3.To compare time to maximum motor block level in both the groups.
4.To note any hemodynamic changes (Heart rate, Systolic Blood pressure, Diastolic Blood pressure), adverse effects and any other observation, if any. |
sample size -80 each group |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/11/2024 |
| 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
|
1.Aim- A comparative evaluation of low dose ropivacaine with fentanyl and low dose bupivacaine with fentanyl in subarachnoid block in transurethral resection of prostate. 2.primary objective- To compare the efficacy of low dose bupivacaine with fentanyl and low dose ropivacaine with fentanyl in terms of duration of sensory blockade. 3.secondary objective- a) to compare onset time to t10 level of sensory block in both the groups , b) to compare time to maximum sensory block level in both the groups , c) to compare time to maximum motor block level in both the groups , d) to note any hemodynamic changes or adverse effects , if any.
study area- department of anesthesia , critical care and perioperative medicine, NDMC and hindu rao hospital , delhi. |