| CTRI Number |
CTRI/2018/04/013254 [Registered on: 13/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two sedative drugs fentanyl and dexmedetomidine as an add on drug to bupivacaine for regional anaesthesia of upper limb surgeries |
|
Scientific Title of Study
|
Comparison of fentanyl and dexmedetomidine as an adjuvant to bupivacaine in ultarsound guided supraclavicular brachial plexus block in upper limb surgeries: a randomized-double blind prospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandeep Mann |
| Designation |
Primary DNB Anaesthesiology |
| Affiliation |
Bhagat Phool Singh Government Medical College For Women |
| Address |
Operation Theatre Complex
Department Of Anaesthesiology
Bhagat Phool Singh Government Medical College For Women
Khanpur Kalan Sonipat Haryana
Operation Theatre Complex
Department Of Anaesthesiology
Bhagat Phool Singh Government Medical College For Women
Khanpur Kalan Sonipat Haryana
Sonipat
HARYANA
131305
India |
| Phone |
8295060202 |
| Fax |
|
| Email |
sandeepmaan86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pranav Bansal |
| Designation |
Professor And Head Of Department Of Anaesthesia |
| Affiliation |
Bhagat Phool Singh Government Medical College For Women |
| Address |
Operation Theatre Complex
Department Of Anaesthesiology
Bhagat Phool Singh Government Medical College For Women
Khanpur Kalan Sonipat Haryana
Operation Theatre Complex
Department Of Anaesthesiology
Bhagat Phool Singh Government Medical College For Women
Khanpur Kalan Sonipat Haryana
Sonipat
HARYANA
131305
India |
| Phone |
8222007555 |
| Fax |
|
| Email |
pranavbansal1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandeep Mann |
| Designation |
Primary DNB Anaesthesiology |
| Affiliation |
Bhagat Phool Singh Government Medical College For Women |
| Address |
Operation Theatre Complex
Department Of Anaesthesiology
Bhagat Phool Singh Government Medical College For Women
Khanpur Kalan Sonipat Haryana
Operation Theatre Complex
Department Of Anaesthesiology
Bhagat Phool Singh Government Medical College For Women
Khanpur Kalan Sonipat Haryana
Sonipat
HARYANA
131305
India |
| Phone |
8295060202 |
| Fax |
|
| Email |
sandeepmaan86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhagat Phool Singh Government Medical College For Women
Khanpur Kalan Sonipat Haryana |
|
|
Primary Sponsor
|
| Name |
Bhagat Phool Singh Government Medical College For Women |
| Address |
Bhagat Phool Singh Government Medical College For Women
Khanpur Kalan Sonipat Haryana |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sandeep Mann |
Operation Theatre Complex Department Of Anaesthesiology |
Bhagat Phool Singh Government Medical College For Women
Khanpur Kalan Sonipat Haryana
Sonipat
HARYANA |
8295060202
sandeepmaan86@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 |
ASA I/II/III, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparison between fentanyl and dexmedetomidine as an adjuvant to bupivacaine in supraclavicular brachial plexus block in upper limb surgeries |
Patients will be randomly assigned into two group BF and BD
BF will receive 26 ml of bupivacaine 0.5 %+8 ml NS+50 µg fentanyl prepared in 1 ml solution and group BD receive 26 ml of bupivacaine 0.5 %+8 ml NS+ 50 µg dexmedetomidine made upto 1 ml solutions |
| Intervention |
comparison of two drugs as an adjuvant to bupivacaine in ultrasound guided supraclavicular brachial plexus block in upper limb surgeries |
Patients will be randomly assigned into two group BF and BD BF will receive 26 ml of bupivacaine 0.5 %+8 ml NS+50 µg fentanyl prepared in 1 ml solution and group BD receive 26 ml of bupivacaine 0.5 %+8 ml NS+ 50 µg dexmedetomidine made upto 1 ml solutions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anesthesiologist’s Grades I to III
2. Patients of either sex
3. Aged 18-65 years |
|
| ExclusionCriteria |
| Details |
1.Patients with known hypersensitivity to local anesthetic drugs
2.Bleeding disorders
3.Pre-existing neuropathy
4.Any hepatic, renal, neurological, psychiatric, or neuromuscular diseases
5.Minor/ pregnancy/ lactation/more than 65 years age will be excluded from the study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Analgesic Efficacy in terms of Onset And Duration Of Motor And Sensory Blockade |
From The Time Of Drug Delivery To 24 Hours Of Postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative Vitals and Heart Rate , Blood Pressure , Sedation Till 24 Hours Postoperatively |
From The Time Of Drug Delivery To 24 Hours Of Postoperatively |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
26/08/2017 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this
randomized double blinded prospective study we intend to examine the effects of
dexmedetomidine v/s fentanyl as an adjuvant to bupivacaine on duration of the
motor block, sensory block, and duration of analgesia and side effects in upper
limb surgeries along with their sedative effects.
64 ASA I-III
patients will be divided in two groups of 32 each after they fulfill the
inclusion and exclusion criteria of the study. Each group will receive
different adjuvant drug for Ultrasound Guided Supraclavicular block and effects
of the same will be observed. And onset time and total duration of motor and
sensory block in both groups will be calculated.and comparison of side effects
in both group will be done. |