| CTRI Number |
CTRI/2023/07/054882 [Registered on: 06/07/2023] Trial Registered Prospectively |
| Last Modified On: |
27/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Effects of adding fentanyl versus tramadol with hyperbaric bupivacaine for spinal anaesthesia in urological surgeries. |
|
Scientific Title of Study
|
A comparative study to assess the effects of intrathecal
fentanyl and intrathecal tramadol combined with 0.5%
bupivacaine heavy in patients undergoing elective
urological surgeries: A prospective randomized study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Baig Mirza Wajeed |
| Designation |
PG Resident |
| Affiliation |
Gajra Raja Medical College, Gwalior, MP |
| Address |
Department of Anaesthesiology, Gajra Raja Medical College
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9423467930 |
| Fax |
|
| Email |
wajeed717@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manmohan Jindal |
| Designation |
Associate Professor |
| Affiliation |
Gajra Raja Medical college, Gwalior |
| Address |
Department of Anaesthesiology, Super Speciality Hospital, Gajra Raja Medical College
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9785728405 |
| Fax |
|
| Email |
drmmjindal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manmohan Jindal |
| Designation |
Associate Professor |
| Affiliation |
Gajra Raja Medical college, Gwalior |
| Address |
Department of Anaesthesiology, Super Speciality Hospital, Gajra Raja Medical College
MADHYA PRADESH
474009
India |
| Phone |
9785728405 |
| Fax |
|
| Email |
drmmjindal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, 7th Floor, C Block, New JAH Building, Gajra raja medical college, Gwalior |
|
|
Primary Sponsor
|
| Name |
Dr Baig Mirza Wajeed |
| Address |
Department of Anaesthesiology, Gajra Raja Medical College, Gwalior |
| 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 |
| Dr Baig Mirza Wajeed |
Jayarogya Hospital |
Department of Anaesthesiology, 7th Floor, C Block, New JAH Hospital, Amkho, Gwalior
Gwalior
MADHYA PRADESH |
9423467930
wajeed717@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Gajra Raja Medical College, Gwalior |
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, (2) ICD-10 Condition: N201||Calculus of ureter, (3) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, (4) ICD-10 Condition: N219||Calculus of lower urinary tract, unspecified, (5) ICD-10 Condition: N400||Benign prostatic hyperplasia without lower urinary tract symptoms, (6) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, (7) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified, (8) ICD-10 Condition: N329||Bladder disorder, unspecified, (9) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hyperbaric Bupivacaine with Fentanyl |
2.5 ml of 0.5% bupivacaine heavy with 0.5 ml of fentanyl (25 µg) intrathecally during induction of spinal anaesthesia |
| Comparator Agent |
Hyperbaric Bupivacaine with Tramadol |
2.5 ml of 0.5% bupivacaine heavy with 0.5 ml of tramadol (25mg) intrathecally during induction of spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving consent to participate in study and scheduled for elective
urosurgery.
Age between 20-60 years
ASA grade I and II |
|
| ExclusionCriteria |
| Details |
Patients not giving consent to participate in the study.
ASA grade III and IV
Patients with respiratory, cardiovascular, hepatic and renal diseases,
obesity and pregnancy.
Age below <20 years and above >60 years.
Any bleeding disorder and patient on anticoagulants.
Neurological and musculoskeletal disease.
Local infection at the injection site.
Patient already receiving any analgesic.
Patient already receiving opioid agonist or antagonist in preceding 6 hrs
of surgery |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prolonged duration of analgesia with the addition of
intrathecal fentanyl.
Stable haemodynamic profile with intrathecal tramadol. |
from induction of spinal anaesthesia to 6 hrs postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lesser side effects with intrathecal tramadol. |
from induction of spinal anaesthesia to 6 hrs postoperative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
06/08/2023 |
| 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="0"
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
|
This is a prospective randomized study to compare and assess the effects of intrathecal fentanyl and intrathecal tramadol combined with 0.5% bupivacaine heavy in patients undergoing elective urological surgeries:
1.To evaluate the duration of analgesia of intrathecal bupivacaine 0.5% heavy with tramadol versus intrathecal bupivacaine 0.5% heavy with fentanyl.
2. To compare hemodynamic changes in both groups.
3. Incidence of side effects if any. |