| CTRI Number |
CTRI/2019/01/017078 [Registered on: 14/01/2019] Trial Registered Prospectively |
| Last Modified On: |
25/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs as an adjuvant to a local anesthetic for post operative pain relief under spinal anesthesia |
|
Scientific Title of Study
|
Comparison Of Effect Of Midazolam Versus Fentanyl As an Adjuvant To Bupivacaine For Post Operative Analgesia In Lower Abdominal Surgeries Under Spinal Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ROSHINI DEVI P |
| Designation |
Post Graduate |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital & Research Centre, |
| Address |
Sri Venkateshwaraa Medical College Hospital & Research Centre,
13-A Pondy - villupuram Main Road
Ariyur
Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9566341988 |
| Fax |
|
| Email |
roshiniog@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PG Mundwadkar |
| Designation |
Professor of Anesthesiology |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital & Research Centre, |
| Address |
Sri Venkateshwaraa Medical College Hospital & Research Centre,
13-A Pondy - villupuram Main Road
Ariyur
Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9844007834 |
| Fax |
|
| Email |
p_mundwadkar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PG Mundwadkar |
| Designation |
Professor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital & Research Centre, |
| Address |
Sri Venkateshwaraa Medical College Hospital & Research Centre,
13-A Pondy - villupuram Main Road
Ariyur
Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9844007834 |
| Fax |
|
| Email |
p_mundwadkar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa Medical College Hospital Research Centre, Ariyur,
Puducherry-605102
|
|
|
Primary Sponsor
|
| Name |
Sri Venkateshwaraa Medical College Hospital Research Centre |
| Address |
13-A ,Pondy - Villupuram Main Road ,
Ariyur,
Puducherry-605102,
INDIA. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Roshini Devi P |
SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Second floor OT complex,
Department of Anesthesiology
Pondicherry
PONDICHERRY |
9566341988
roshiniog@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
group F |
This group of patients will receive 20mcg fentanyl (0.4ml ) as an adjuvant to 3ml of 0.5% bupivacaine |
| Intervention |
Group M |
This group of patients will receive 2mg (0.4ml)of midazolam as an adjuvant to 3ml of 0.5% bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I & II
Age 18 to 60 years of Both Sex
|
|
| ExclusionCriteria |
| Details |
Patients with any contraindication for spinal anesthesia
Patients with psychiatric illness or on any antipsychotic Medication
Short stature.
Allergic to local anesthetic
Patients converted to general anesthesia
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of post-operative pain relief |
Assessed at every 30 minutes interval until the first dose of pain killer is given.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to onset of sensory and motor block. |
This will be assessed only once after spinal anesthesia. The time taken for establishment of sensory and motor block will be noted. |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/01/2019 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not done. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a post-graduate thesis approved by Institutional ethical committee on 28 Nov.2018. Two drugs are to be compared in this study. The study is likely to be started on 15 Jan 2019. |