| CTRI Number |
CTRI/2022/03/041477 [Registered on: 30/03/2022] Trial Registered Prospectively |
| Last Modified On: |
29/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to know the effects of magnesiun sulphate and fentanyl in spinal anesthesia. |
|
Scientific Title of Study
|
Comparison of subarachnoid magnesium sulphate and fentanyl as adjuvants with 0.5% heavy bupivacaine for post operative analgesia in infraumbilical surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gagandeep Kaur |
| Designation |
Post graduate junior resident |
| Affiliation |
Mayo institute of medical sciences barabanki |
| Address |
3rd floor,Department of Anesthesiology,Mayo institute of medical sciences barabanki, uttar pradesh, 225001
Barabanki
UTTAR PRADESH
225001
India |
| Phone |
9896043154 |
| Fax |
|
| Email |
gagandeeplakhyan28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Singh Negi |
| Designation |
Director |
| Affiliation |
Mayo institute of medical sciences |
| Address |
3rd floor,Department of Anesthesiology,Mayo institute of medical sciences barabanki, uttar pradesh, 225001
Barabanki
UTTAR PRADESH
225001
India |
| Phone |
9415003178 |
| Fax |
|
| Email |
drdevendranegi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gagandeep Kaur |
| Designation |
Post graduate junior resident |
| Affiliation |
Mayo institute of medical sciences barabanki |
| Address |
3rd floor,Department of Anesthesiology ,Mayo institute of medical sciences barabanki, uttar pradesh, 225001
Barabanki
UTTAR PRADESH
225001
India |
| Phone |
9896043154 |
| Fax |
|
| Email |
gagandeeplakhyan28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mayo institute of medical sciences barabanki uttar pradesh |
|
|
Primary Sponsor
|
| Name |
Mayo institute of medical sciences |
| Address |
Mayo institute of medical sciences barabanki 225001 |
| Type of Sponsor |
Private 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 |
| Gagandeep kaur |
Mayo institute of medical sciences |
3rd floor,Department of Anesthesiology,Mayo institute of medical sciences,barabanki
Barabanki
UTTAR PRADESH |
9896043154
gagandeeplakhyan28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MIMS institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine |
15 mg in subarachnoid space in subarachnoid block |
| Comparator Agent |
Magnesium surface, Fentanyl |
Magnesium surface 100 mg in subarachnoid space as adjuvant local anaesthetic agent in subarachnoid block
Fentanyl 25 mcg in subarachnoid space as adjuvant to local anaesthetic agent in subarachnoid block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Consent for participation in the study
Both sex
Age 18 to 55 years
ASA grade 1 and 11
Infraumbilical surgeries. |
|
| ExclusionCriteria |
| Details |
Refusal for participation in the study
ASA Grade above III
History of any drug allergies
Opioid addicts
Anatomical spinal deformities/malformations
Any chronic comorbidity
Any acute URTI or fever |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Block characteristics
2. Hemodynamic stability in intra and post-operative phase
3. Post-operative requirement of rescue analgesia and its dose |
12-18 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onset and regression of sensory and motor blocks |
14-20 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
04/04/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There have been several studies conducted where adjuvants added to local anesthetic agent for prolongation of analgesic effect. From this study we would like to find out the efficacy of blockade,duration of analgesia,requirement of analgesic dose after addition of magnesium sulphate and fentanyl to bupivacaine in subarachnoid block. |