| CTRI Number |
CTRI/2024/11/077064 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of effects of the Dexmedetomidine and Fentanyl as an adjuvant to Levobupivacaine in lower abdominal surgeries. |
|
Scientific Title of Study
|
Comparison of the effects of Dexmedetomidine and Fentanyl as an adjuvant to 0.5% hyperbaric Levobupivacaine in lower abdominal surgeries :A randomized clinical trial. |
| 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 Varsha Jangra |
| Designation |
Post Graduate Student |
| Affiliation |
Maharaja Agrasen Medical College,Agroha,District Hisar |
| Address |
OT Complex
Department Of Anaesthesia , Maharaja Agrasen Medical College ,Agroha,
District Hisar
Hisar
HARYANA
125047
India |
| Phone |
7988225720 |
| Fax |
|
| Email |
varshajangra03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal |
| Designation |
Professor |
| Affiliation |
Maharaja Agrasen Medical College,Agroha,District Hisar |
| Address |
Department Of Anaesthesia,Maharaja Agrasen Medical College,Agroha, District Hisar
Hisar
HARYANA
125047
India |
| Phone |
8950426301 |
| Fax |
|
| Email |
sheetalbhatia1234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Sheetal |
| Designation |
Professor |
| Affiliation |
Maharaja Agrasen Medical College,Agroha,District Hisar |
| Address |
Department Of Anaesthesia , Maharaja Agrasen Medical College,Agroha,District Hisar
Hisar
HARYANA
125047
India |
| Phone |
8950426301 |
| Fax |
|
| Email |
sheetalbhatia1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharaja Agrasen Medical College Agroha District Hisar Haryana,125047 |
|
|
Primary Sponsor
|
| Name |
Dr Varsha Jangra |
| Address |
Maharaja Agrasen Medical college,Agroha,Hisar,Haryana |
| 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 Varsha Jangra |
Maharaja Agrasen Medical College |
OT Complex Department Of Anaesthesia
Hisar
HARYANA |
7988225720
varshajangra03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHARAJA AGRASEN MEDICAL COLLEGE AGROHA HISAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA1 and2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of the effects of Dexmedetomidine and Fentanyl as an adjuvant to 0.5% hyperbaric Levobupivacaine in lower abdominal surgeries :A randomized clinical trial. |
Spinal anaesthesia with 0.5%Hyperbaric Levobupivacaine and Dexmedetomide in lower abdominal surgeries. For 1 year and 4 months
|
| Comparator Agent |
Comparison of the effects of Dexmedetomidine and Fentanyl as an adjuvant to 0.5% hyperbaric Levobupivacaine in lower abdominal surgeries :A randomized clinical trial. |
Spinal anaesthesia with 0.5%Hyperbaric Levobupivacaine and Fentanyl in lower abdominal surgeries
For 1 year and 4 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
AMERICAN SOCIETY OF ANAESTHESIOLOGIST(ASA) PHYSICAL STATUS CLASS 1 AND 2 |
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal.
2. Patient having Bleeding disorders.
3. Patient having Neurological disease.
4. Patient having Local skin infections at the
site of spinal block.
5. Patient having Severe back deformities.
6. Patient having Raised intracranial pressure.
7. Patient having Cardiac and respiratory disease.
8. Patient of Morbid obesity.
9. Patient having allergy to study drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The onset of sensory block at T-10 level will be taken as the time from injection of anesthetic solution to the loss of sensation to pinprick.
2.Duration will be taken as from time of onset to time at which patient feel sensation to pinprick at T-10.
3.Onset time of motor block will be taken as the time to acquire complete motor block after the intrathecal injection of local anesthetic.
4.Total duration will be taken as time from onset to completely recover from the motor block. |
After the block, vitals will be monitored 2, 5, 10, 15, 20 and 30 min and thereafter, every 10 min interval till 90 minutes and 30 min intervals thereafter. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
HYPOTENSION
BRADYCARDIA
NAUSEA
VOMITING
SHIVERING |
TOTAL DURATION WILL BE TAKEN AS TIME TO COMPLETELY RECOVER FROM THE BLOCK |
|
|
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 |
|
Date of First Enrollment (India)
|
30/11/2024 |
| 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="4"
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
|
THIS STUDY WILL BE CONDUCTED IN A PROSPECTIVE , RANDOMIZED , DOUBLE BLINDED AND COMPARATIVE MANNER IN A DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, MAHARAJA AGRASEN MEDICAL COLLEGE , AGROHA. PRIMARY OBJECTIVES OF THE STUDY WILL BE; TO ESTIMATE ONSET OF SENSORY AND MOTOR BLOCK. TO ESTIMATE DURATION OF SENSORY AND MOTOR BLOCK.
SECONDARY OBJECTIVES OF THE STUDY WILL BE; TO ESTIMATE ANY HEMODYNAMIC CHANGES. TO ESTIMATE SIDE EFFECTS IF ANY.
|