| CTRI Number |
CTRI/2023/09/057342 [Registered on: 06/09/2023] Trial Registered Prospectively |
| Last Modified On: |
01/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find out which drug is better between Midazolam versus Fentanyl when used as an adjuvant with 0.5% hyperbaric Levobupivacaine in achieving prolonged post operative pain relief in patients undergoing elective lower limb surgeries under spinal anesthesia |
|
Scientific Title of Study
|
Comparative study on analgesic efficacy of Midazolam versus Fentanyl as an adjuvant to 0.5% hyperbaric levobupivacaine in spinal anesthesia for patients undergoing elective lower limb surgeries a randomized interventional study at SMS medical college Jaipur |
| 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 Sonali Beniwal |
| Designation |
Associate Professor |
| Affiliation |
S.M.S MEDICAL COLLEGE AND ATTACHED HOSPITALS |
| Address |
Department of Anesthesiology,Second floor, Dhanwantri complex, Sawai Man Singh Medical College and Attached Hospitals, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214540552 |
| Fax |
|
| Email |
drsonalisms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Beniwal |
| Designation |
Associate Professor |
| Affiliation |
S.M.S MEDICAL COLLEGE AND ATTACHED HOSPITALS |
| Address |
Department of Anesthesiology, Second floor, Dhanvantri complex, Sawai Man Singh Medical College and Attached Hospitals, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214540552 |
| Fax |
|
| Email |
drsonalisms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Harita Haridas |
| Designation |
Junior Resident |
| Affiliation |
S.M.S MEDICAL COLLEGE AND ATTACHED HOSPITALS |
| Address |
Department of Anesthesiology,Second floor,Dhanvantri complex, Sawai Man Singh Medical College and Attached Hospitals, Adarsh Nagar,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9544956391 |
| Fax |
|
| Email |
haridasharita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Sawai Man Singh Medical College and Attached Hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology, S.M.S Medical College and Attached Hospitals |
| Address |
JLN Marg, Adarsh Nagar, Jaipur |
| 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 Harita Haridas |
Sawai Man Singh Medical College and Attached Hospitals |
Department of Anesthesiology, Second Floor, Dhanwantari Building, S.M.S Medical College and Attached Hospitals, JLN Marg, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN |
9544956391
haridasharita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethics committee S.M.S Medical College and Attached Hospitals, Jaipur |
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 |
Spinal anesthesia with 0.5% Hyperbaric Levobupivacaine with fentanyl as adjuvant |
Spinal anesthesia with 0.5% Hyperbaric Levobupivacaine 10 mg in 2 ml with 25 mcg fentanyl in 0.5 ml and 0.5 ml normal saline making a total volume of 3 ml after which the patient is monitored for sensory and motor block duration, vitals and adverse effects for 24 hours. |
| Intervention |
Spinal anesthesia with 0.5% Hyperbaric Levobupivacaine with midazolam as adjuvant. |
Spinal anesthesia given with 0.5% Hyperbaric Levobupivacaine 10 mg in 2 ml with 2.5 mg Midazolam in 0.5 ml and 0.5 ml normal saline making a total volume of 3 ml after which the patient is monitored for sensory and motor block duration, vitals and adverse effects for 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to participate in the study with written informed consent
2. Patients age between 20 to 60 years
3. Height of the patient is more than 145 cms
4. Patients undergoing elective lower limb surgeries
5. Patients belonging to ASA physical status I or II
|
|
| ExclusionCriteria |
| Details |
1. Patients with bacteremia sepsis or skin infection of local site
2. Patient with severe hypovolemia or anemia or compromised renal cardiac or respiratory status
3. Patients with raised intracranial tension
4. Patients with abnormal coagulation profile
5. Patients allergic to drugs used for study
6. Uncooperative patients
7. Patients in whom spinal anesthesia failed and general anesthesia was required |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the average time for the need of first dose of rescue analgesia |
Every 30 minutes for 6 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the average time for the onset of sensory block |
Every 2 minutes till highest level attained |
| To determine the average time for the onset of motor block |
Every 2 minutes till maximum motor block |
| To determine the average duration of sensory block |
Every 30 minutes till 6 hours postoperatively |
| To determine the average duration of motor block |
Every 30 minutes till 6 hours postoperatively |
| To compare the changes in cardiocirculatory parameters ( HR, SBP, DBP, MBP) |
Every 5 minutes for first 30 minutes followed by every 10 minutes till completion of surgery then every 30 minutes for 6 hours postoperatively |
| To determine the VAS score |
Every 30 minutes for 6 hours postoperatively |
| Adverse events if any to be noted |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
12/09/2023 |
| 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="0"
Months="3"
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
|
In this study our aim is to find out which drug is better between Midazolam versus Fentanyl used as adjuvant with 0.5% Hyperbaric Levobupivacaine in achieving prolonged postoperative analgesia in patients undergoing elective lower limb surgeries under spinal anesthesia. |