| CTRI Number |
CTRI/2023/09/058000 [Registered on: 25/09/2023] Trial Registered Prospectively |
| Last Modified On: |
30/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing Dexmedetomidine and Fentanyl with Ropivacaine for spinal anaesthesia |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine and Fentanyl as adjuvants to 0.75% hyperbaric Ropivacaine for spinal anaesthesia in orthopaedic lower limb surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amritha sai |
| Designation |
Junior resident |
| Affiliation |
Rajendra institute of medical sciences, Ranchi |
| Address |
Department of Anesthesiology,
Rajendra institute of medical sciences, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9895110764 |
| Fax |
|
| Email |
amrithasai8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. PK Tiwari |
| Designation |
Associate professor |
| Affiliation |
Rajendra institute of medical sciences, Ranchi |
| Address |
Department of Anesthesiology
Rajendra institute of medical sciences, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
|
| Fax |
|
| Email |
drpkt80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amritha sai |
| Designation |
Junior resident |
| Affiliation |
Rajendra institute of medical sciences, Ranchi |
| Address |
Department of Anesthesiology
Rajendra Institute of medical sciences,Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9895110764 |
| Fax |
|
| Email |
amrithasai8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia ,RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI |
|
|
Primary Sponsor
|
| Name |
Rajendra institute of medical sciences Ranchi |
| Address |
Department of Anesthesiology,
Rajendra institute of medical sciences, Ranchi |
| 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 |
| Amritha sai |
Rajendra institute of medical sciences,Ranchi |
Orthopaedics operation theatre,orthopaedics department, ground floor
Ranchi
JHARKHAND |
9895110764
amrithasai8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Rajendra institute of medical sciences, Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 7||Osteopathic, (2) ICD-10 Condition: M848||Other disorders of continuity of bone, (3) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ropivacaine and fentanyl in spinal anaesthesia |
3ml of 0.75% hyperbaric ropivacaine and 25mcg fentanyl(0.5ml) administered via intrathecal route,single dose.Effects monitored for 12hours |
| Comparator Agent |
ropivacaine and sterile normal saline for spinal anaesthesia |
3ml of 0.75% hyperbaric ropivacaine and 0.5ml of sterile normal saline administered via intrathecal route,single dose.Effects monitored for 12hours |
| Intervention |
Ropivacaine with dexmedetomidine in spinal anaesthesia |
3ml of 0.75% hyperbaric ropivacaine and 10 mg of dexmedetomidine(0.5ml), administered via intrathecal route,single dose.Effects monitored for 12hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patients consent
2.ASA physical class 1 and 2
3.elective lower limb orthopaedic surgery cases with duration of surgery not more than 2 hours |
|
| ExclusionCriteria |
| Details |
1.patient having contraindication for spinal anesthesia
2.pregnant females
3.patient with chronic disease
4.patient with BMI>30kg/m2
4.patient shorter than 150cms |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset and duration of sensory block in all three groups |
From time of induction till T10 level of block achieved for onset(within 30 mins of induction).
For duration,from time of induction till patient feels the sensation at S1 dermatome
(till 12hrs after induction) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| maximum sensory blockade attained & time taken for same |
30 -45 mins after induction |
| time taken for two segment sensory regression |
till 12 hrs post induction |
| onset & duration of motor block |
30mins post induction for onset
12hrs post induction for duration |
| quality of motor block & time taken for the maximum motor blockade |
till 30 mins post induction |
| total duration of analgesia |
till 12hrspost induction |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 4 |
|
Date of First Enrollment (India)
|
08/10/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal anaesthesia is most widely used technique for lower limb surgeries. Ropivacaine is a long acting amide local anaesthesia. It is less cardiotoxic and has greater motor sensory differentiation. Intrathecal adjuvants prolong the duration and quality of block. Dexmedetomidine is alpha agonist, with high specificity for alpha 2 receptors. It has centrally mediated sedative, analgesic, opioid sparing, sympatholytic properties. It prolongs the sensory and motor block when added to spinal anaesthesia. Fentanyl is potent synthetic opiate agonist. It enhances the analgesic potency of ropivacaine for spinal anaesthesia. This study is undertaken to compare the safety,quality, efficacy of intrathecal demedetomidine 10mcg and 0.75% hyperbaric ropivacaine combination, as compared to fentanyl 25 mcg and 0.75% hyperbaric ropivacaine for orthopaedic lower limb surgeries.
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