| CTRI Number |
CTRI/2025/01/079279 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
AN OBSERVATIONAL STUDY BETWEEN INTRATHECAL HYPERBARIC BUPIVACAINE 0.5 Percent
3.3cc WITH DEXMEDATOMEDINE 10 MICROGRAM VERSUS HYPERBARIC BUPIVACAINE
0.5 percent 3.3cc WITH NALBUPHINE 1 MG Intrathecally IN LOWER LIMB ORTHOPAEDIC SURGERIES |
|
Scientific Title of Study
|
A COMPARATIVE STUDY BETWEEN INTRATHECAL DEXMEDATOMEDINE VERSUS NALBUPHINE AS AN ADDITIVE WITH HYPERBARIC BUPIVACAINE 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 |
Dr 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 |
kartik.svdu2022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilesh Shah |
| Designation |
Professor |
| 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 |
9825038233 |
| Fax |
|
| Email |
nileshshah730@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilesh Shah |
| Designation |
Professor |
| 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 |
9825038233 |
| Fax |
|
| Email |
nileshshah730@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
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 |
| Dr 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
Vadodara
GUJARAT |
08767272524
kartik.svdu2022@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: M171||Unilateral primary osteoarthritisof knee, |
|
|
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
Dose - 10MCG
Route - Intrathecally
Duration- Till adminstration of Rescue 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
Dose - 1mg
Route - Intrathecally
Duration- Till adminstration of Rescue analgesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 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.
Patient not NIL by mouth.
History of seizure disorder.
Known allergy to trial drugs.
Patients with neurological disorders and neuropathies or receiving
medications known to influence neuromuscular junction.
ASA III, IV, V Patients.
Patient with prior pre-existing Comorbidities (Heart diseases,
Respiratory disease, Kidney diseases, known fetal abnormalities)
Pregnant females
Failed spinal anesthesia converted to general anesthesia
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 |
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
20 mins
30 mins
45 mins
60 mins
90 mins
120 mins
150 mins
180 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare duration of post operative analgesia in group dexmedatomedine & group nalbuphine |
time at which rescue analgesia was given
Vas Score at induction
At 4 hours
6 hours
8 hours
Or anytime between when Vas Score More then 4 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
10/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
INTRODUCTION:- Spinal anesthesia with hyperbaric bupivacaine 0.5%(heavy) is a popular method however there is a disadvantage of its short half-life. To overcome this disadvantage there is a constant search for an ideal adjuvant. Initially, opioids like fentanyl and buprenorphine were tried. Opioids reduce the toxicity and adverse cardiovascular effects of local anesthetics, however, this type of combination brings about additional undesirable problems like itching, nausea and vomiting and /or respiratory depression. AIM:-, Aim of this study is to compare the efficacy of Dexmedetomidine and Nalbuphine used as additive to bupivacaine in subarachnoid block in lower limb orthopedic surgeries OBJECTIVES:- TO COMPARE Onset , duration of sensory and motor blockade Sedation of patients. The hemodynamic changes in (HR, BP, SpO2 and RR ) Duration of absolute analgesia and effective analgesia. The requirement of a number of rescue analgesia. The side effects/ Complications. MATERIALS AND METHODOLOGY All the patients aged between 20 to 60 years old belonging to the American Society of Anesthesiologists (ASA) grade I or II undergoing elective lower limb Orthopedic surgery will be taken for the study. Written and informed consent will be taken from all the selected patients. Sunarachnoid Block Will be given in 2 different Groups of 30 each.
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