| CTRI Number |
CTRI/2024/09/073204 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check the effects of three different doses of fentanyl with heavy bupivacaine in lower abdominal and lower limb surgeries
|
|
Scientific Title of Study
|
To assess the effects of three different doses of intrathecal fentanyl with hyperbaric bupivacaine in spinal anaesthesia for lower abdominal and lower extremities surgeries
|
| 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 Karan Goyal |
| Designation |
Post Graduate Resident |
| Affiliation |
Varun arjun medical college and rohilkhand hospital |
| Address |
Department of anaesthesia
Varun arjun medical college and rohilkhand hospital lucknow road banthara district shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8054213966 |
| Fax |
|
| Email |
karangoyal93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bashir Ahmad Mir |
| Designation |
Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anaesthesia
Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthara. District- Shahjahanpur.
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9682536855 |
| Fax |
|
| Email |
mirbashir96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyen Verma |
| Designation |
Assistant Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anaesthesia
Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthara. District- Shahjahanpur.
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7007564027 |
| Fax |
|
| Email |
vermasatyen1986@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College and Rohilkhand Hospital Lucknow road Banthara district Shahjahanpur. Uttar Pradesh (India)
Pin code- 242307 |
|
|
Primary Sponsor
|
| Name |
Dr Karan Goyal |
| Address |
room no. 1004 department of anaesthesia first floor
Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthara. District- Shahjahanpur
Uttar Pradesh, India
Pin code- 242307 |
| 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 Karan Goyal |
Rohilkhand Hospital Banthara, Shahjahanpur |
Department of Anaesthesia
Varun Arjun Medical College, Banthara. District- Shahjahanpur, Uttar Pradesh, India
Shahjahanpur
UTTAR PRADESH |
8054213966
karangoyal93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Varun Arjun Medical College & Rohilkhand Hospital NH-24 Banthara shahjahanpur Uttar Pradesh 242307 India |
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 |
| Comparator Agent |
Bupivacaine with fentanyl (37.5mcg) |
Patient undergoing for lower abdominal and lower extremities surgeries in spinal anaesthesia using intrathecal fentanyl dose 0.75ml (37.5 mcg) plus 2.8 ml (14mg) hyperbaric bupivacaine 0.5% heavy will be done for 1 year |
| Comparator Agent |
Bupivacaine with fentanyl(12.5mcg) |
Patient undergoing for lower abdominal and lower extremities surgeries in spinal anaesthesia using intrathecal fentanyl dose 0.25ml (12.5 mcg) plus 2.8 ml (14mg) hyperbaric bupivacaine 0.5% heavy plus 0.5 ml normal saline will be done for 1 year |
| Intervention |
Bupivacaine with fentanyl(25mcg) |
Patient undergoing for lower abdominal and lower extremities surgeries in spinal anaesthesia using intrathecal fentanyl dose 0.5ml (25 mcg) plus 2.8 ml (14mg) hyperbaric bupivacaine 0.5% heavy plus 0.25 ml normal saline will be done for 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists ASA grade I and II (except pregnancy or breastfeeding women)
Patients who gave written informed consent
Patients scheduled for elective lower abdominal and lower extremities surgeries under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
American Society of Anesthesiologists ASA grade III or greater
Age less than 18 years, more than 60 years
Emergency surgeries or procedures requiring immediate intervention
Patients with significant medical conditions such as severe cardiovascular disease, respiratory insufficiency, or neurological disorders that contraindicate spinal anaesthesia
•History of opioid dependence or substance abuse
•Known allergies or hypersensitivity to fentanyl, hyperbaric
bupivacaine, or any components of the study medications
•Patients with coagulation disorders or receiving anticoagulant
therapy that increases the risk of bleeding complications
associated with spinal anaesthesia
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore the dose-response relationship between intrathecal fentanyl and hyperbaric bupivacaine regarding anaesthesia quality and duration |
Every 3 min for 15 min then every 15 min till recovery
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify any potential predictors of optimal dose selection for intrathecal fentanyl based on individual patient factors & surgical requirements |
Every 3 min for 15 min then every 15 min till recovery
2 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
02/09/2024 |
| 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
|
The study titled "Comparing the Effects of Different Doses of Intrathecal Fentanyl Combined with Hyperbaric Bupivacaine for Spinal Anaesthesia in Lower Abdominal and Lower Extremity Surgeries" will be conducted in department of Anaesthesia,
Varun Arjun Medical College and Rohilkhand Hospital, Banthara, Shahjahanpur, Uttar Pradesh 242307 focusing on elective lower abdominal and lower extremities surgeries under spinal anaesthesia.
A. The study will involve patients scheduled for elective surgeries requiring spinal anaesthesia, based on specific inclusion and exclusion criteria.
B. Each patient will undergo a thorough medical history review and provide written informed consent.
C. Participants will undergo a preoperative clinical and laboratory assessment.
D. Patients will be admitted one day prior to surgery.
E. Participants will be randomly allocated into three groups:
Group A: Intrathecal fentanyl 12.5 mcg with 0.5% hyperbaric bupivacaine.
Group B: Intrathecal fentanyl 25 mcg with 0.5% hyperbaric bupivacaine.
Group C: Intrathecal fentanyl 37.5 mcg with 0.5% hyperbaric bupivacaine.
F. The study will evaluate the effects on anaesthesia quality, onset, duration of sensory and motor block, hemodynamic stability, and adverse reactions. Data on vital signs, block duration, and side effects will be collected throughout the study. |