| CTRI Number |
CTRI/2024/11/076686 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
AN OBSERVATIONAL STUDY BETWEEN INTRATHECAL HYPERBARIC BUPIVACAINE 0.5% 3.3cc WITH DEXMEDATOMEDINE 10 MICROGRAM VERSUS HYPERBARIC BUPIVACAINE 0.5% 3.3cc WITH NALBUPHINE 1 MG IN LOWER LIMB ORTHOPAEDIC SURGERIES |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY OF COMPARISION BETWEEN INTRA-THECAL HYPERBARIC BUPIVACAINE 0.5% 3.3cc WITH DEXMEDATOMEDINE 10Mcg VERSUS HYPERBARIC BUPIVACAINE 0.5% 3.3cc WITH NALBUPHINE 1 mg IN LOWER LIMB ORTHOPAEDIC SURGERIES |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kartik H Sangam |
| Designation |
Resident Doctor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre |
| Address |
Anaesthesia Department, General OT complex, 2nd Floor Dhiraj Hsopital, Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre, Waghodia , Piparia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
08767272524 |
| Fax |
|
| Email |
sangam2494@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kartik H Sangam |
| Designation |
Resident Doctor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre |
| Address |
Anaesthesia Department, General OT complex, 2nd Floor Dhiraj Hsopital, Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre, Waghodia , Piparia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8767272524 |
| Fax |
|
| Email |
sangam2494@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kartik H Sangam |
| Designation |
Resident Doctor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre |
| Address |
Anaesthesia Department, General OT complex, 2nd Floor Dhiraj Hsopital, Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre, Waghodia , Piparia, Vadodara
GUJARAT
391760
India |
| Phone |
08767272524 |
| Fax |
|
| Email |
sangam2494@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre |
|
|
Primary Sponsor
|
| Name |
Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre |
| Address |
Waghodia, Pipariya, vadodara, Gujarat, india- 391760 |
| 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 |
| Kartik H Sangam |
Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre |
Anaesthesia Department, General OT complex, 2nd Floor Dhiraj Hsopital, Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre, Waghodia , Piparia, Vadodara- 391760
Vadodara
GUJARAT |
08767272524
sangam2494@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M160||Bilateral primary osteoarthritis of hip, (2) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (3) ICD-10 Condition: M864||Chronic osteomyelitis with draining sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
inj. dexmedatomedine 10 mcg intracthecally with hyperbaric bupivacaine
|
inj. dexmedatomedine 10 mcg intrathecally as an additive to inj. bupivcaine hyperbaric to compare the hemodynamic stabilty and post operative analgesia |
| Comparator Agent |
inj. nalbuphine 1 mg intrathecally |
inj nalbuphine 1 mg as additive to hyperbaric bupivacine 3 cc intrathecally to comapre hemodynamic stability and post operative analegsia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to sign the informed written consent.
Patients of ASA Grade I and II of either gender.
Under Spinal anaesthesia for elective pelvic and lower limb surgeries
Aged 20 - 60 years.
No known history of allergy, sensitivity to local anaesthetics of the amide group and other drugs used for this study. |
|
| ExclusionCriteria |
| Details |
Patient refusal.
â— Patient not NIL by mouth.
â— History of seizure disorder.
â— Known allergy to trial drugs.
â— Patients with neurological disorders and neuropathies or receiving medications known to influence neuromuscular junction.
â— ASA III, IV, V Patients.
â— Patient with prior pre-existing Comorbidities (Heart diseases, Respiratory disease, Kidney diseases, known fetal abnormalities)
â— Pregnant females
â— Failed spinal anesthesia converted to general anesthesia
â— Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities. Patients fulfilling above inclusion criteria are taken for study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
to Compare efficacy of dexmedatomedine and
nalbuphine in blunting hemodynamic response
and post operative analesgia in patient recieving
Spinal anaesthesia in lower limb orthopedic
surgeries |
Baseline
0 min
2 mins
5 mins
10 mins
15 mins
20 mins
30 mins
45 mins
60 mins
75 mins
90 mins
120 mins
150 mins
180 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare duration of post operative analgesia in group dexmedatomedine and group nalbuphine |
time at which rescue analgesia was given. |
|
|
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)
|
16/11/2024 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study is to compare the efficiacy of 2 days (inj. dexmedatomedine 10 mcg and inj. Nalbuphine 1mg) in spinal anesthesia in blunting the hemodynamic response and post operative analegsia in spinal anaesthesia in lower limb orthopeadic surgeries. |