| CTRI Number |
CTRI/2023/04/051460 [Registered on: 11/04/2023] Trial Registered Prospectively |
| Last Modified On: |
07/04/2023 |
| 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 INTRATHECAL FENTANYL, DEXMEDETOMIDINE AND CLONIDINE AS ADJUVANTS TO HEAVY BUPIVACAINE FOR LOWER LIMB SURGERY IN ADULT PATIENTS |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED STUDY TO COMPARE INTRATHECAL FENTANYL, DEXMEDETOMIDINE AND CLONIDINE AS ADJUVANTS TO HYPERBARIC BUPIVACAINE FOR LOWER LIMB SURGERY IN ADULT PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Umar Sherwani |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University,Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417886114 |
| Fax |
|
| Email |
sherwaniumar9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syed Kamran Habib |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University,Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897172780 |
| Fax |
|
| Email |
syedkamranhabib@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Umar Sherwani |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University,Aligarh |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University,Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417886114 |
| Fax |
|
| Email |
sherwaniumar9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care ,Jawaharlal Nehru Medical College, Aligarh Muslim University,Aligarh |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College AMUAligarh |
| Address |
Aligarh Muslim University |
| 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 |
| Umar Sherwani |
Jawaharlal Nehru Medical College, AMU |
Department of Anaesthesiology and Critical Care ,Jawaharlal Nehru Medical College, Aligarh Muslim University,Aligarh,
Aligarh
UTTAR PRADESH |
7417886114
sherwaniumar9@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: S829||Unspecified fracture of lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CLONIDINE GROUP |
Intrathecally 12.5mg (2.5ml) 0.5% bupivacaine with clonidine 30mcg(0.2ml)+preservative free normal saline (0.3ml)
|
| Intervention |
DEXMEDETOMIDINE GROUP |
Intrathecally 12.5mg (2.5ml) 0.5% bupivacaine with pre-diluted Dexmedetomidine 5mcg(0.5ml) |
| Comparator Agent |
FENTANYL GROUP |
Intrathecally 12.5mg (2.5ml) 0.5% bupivacaine with fentanyl 25mcg(0.5ml) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
A.S.A I & II Patients
Patients planned for elective lower limb surgery under Sub-Arachnoid Block
|
|
| ExclusionCriteria |
| Details |
1)Patients with contraindications to regional anaesthesia
2)Patients with disease like diabetes ,peripheral neuropathy.
3)Patients with history of coexisting diseases like ischaemic heart diseases, hypertension, impaired renal functions, rheumatoid arthritis and severe liver diseases .
4)Patients with known allergy to local anaesthetic
5) pregnant patients, chronic alcoholics, AV Blocks, incomplete heart blocks , intake of alpha-blockers.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of sensory and motor block |
The duration of sensory block was defined as the time of regression of two segments in the maximum block height, evaluated by pinprick.
Duration of motor block was defined as time from which patient acheive modified bromage 3 to modified bromage 0. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Onset of sensory and motor block
2.Time to two segments regressions of block
3.Duration of Spinal Anaesthesia in each group
4.To compare the hemodynamic changes among three groups:
a) Heart Rate(HR)
b)Mean Arterial Pressure(MAP).
5. Perioperative Ramsay Sedation Score
6. Complications (nausea, vomiting , pruritis)
|
The onset of sensory block was defined as the time between injection of intrathecal anesthetic and the absence of pain at the T8 dermatome assessed by sterile pinprick every 2 min till T8 dermatome was achieved.
Time for motor block onset was defined as modified Bromage score of 3.
The duration of spinal anesthesia shall be defined as the period from spinal injection to the first occasion when the patient complained of pain in the postoperative period.
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
12/04/2023 |
| 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="2"
Months="0"
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
|
Spinal, epidural or combined spinal-epidural
anaesthesia are the most popular and reliable techniques for lower limb
surgery. Prolongation of intraoperative and postoperative intrathecal
anaesthesia and analgesia has been achieved by addition of various adjuvants
such as Fentanyl, epinephrine and alpha-2 agonists like clonidine and
dexmedetomidine. Various clinical trials have found that
administration of dexmedetomidine, fentanyl and clonidine with local anaesthetics prolonged the duration of sensory and motor
blockade.
In this study we plan to compare the Intrathecal fentanyl, clonidine and dexmedetomidine as adjuvants to
hyperbaric bupivacaine on onset and duration of block , time to two segments
regressions of block and duration of spinal anaesthesia for elective lower limb
surgery in adult patients.
|