| CTRI Number |
CTRI/2024/08/072638 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
10/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the effects of adding two different medicines (dexmedetomidine and fentanyl) to a spinal anesthetic (bupivacaine) for surgeries on the lower legs. |
|
Scientific Title of Study
|
Comparative addition of dexmedetomidine and fentanyl to intrathecal bupivacaine in orthopaedic procedure in lower limbs |
| 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 Usha Vasandani |
| Designation |
MD Anaesthesia 1st year |
| Affiliation |
Sharda University School of Medical Sciences and Research |
| Address |
Department of Anaesthesiology, Sharda University School of Medical Sciences and Research, plot no 32, 34, Knowledge Park III, Greater Noida, Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9958286800 |
| Fax |
|
| Email |
peeu82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiv Kumar Singh |
| Designation |
Professor |
| Affiliation |
Sharda University School of Medical Sciences and Research |
| Address |
Department of Anaesthesiology, Sharda University School of Medical Sciences and Research, plot no 32, 34, Knowledge Park III, Greater Noida, Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9650943359 |
| Fax |
|
| Email |
shiv.singh@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shiv Kumar Singh |
| Designation |
Professor |
| Affiliation |
Sharda University School of Medical Sciences and Research |
| Address |
Department of Anaesthesiology, Sharda University School of Medical Sciences and Research, plot no 32, 34, Knowledge Park III, Greater Noida, Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9650943359 |
| Fax |
|
| Email |
shiv.singh@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sharda University School of Medical Sciences and Research |
| Address |
plot no 32, 34, Knowledge Park III, Greater Noida, Uttar Pradesh 201310 |
| 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 Usha Vasandani |
Sharda Hospital, School of medical sciences and research |
Department of
Anaesthesiology, 2nd
floor, b block, School of medical sciences and research, plot no 32, 34, Knowledge Park III, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9958286800
peeu82@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: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
intrathecal bupivacaine |
Group I: BN Group [0.5% hyperbaric bupivacaine 3ml + Normal Saline 0.5ml].
Frequency : once.
Duration : 3 hrs.
Dose : mentioned above |
| Intervention |
intrathecal dexmedetomidine and fentanyl |
Either Group II or Group III
Group II: BD Group [3mL of 0.5% hyperbaric bupivacaine plus 5 μg dexmedetomidine
(diluted in 0.5ml of normal saline) intrathecal]
Group III: BF Group [3 mL of 0.5% hyperbaric bupivacaine plus 25 μg fentanyl (0.5ml)
intrathecal Fentanyl]
Frequency : once.
Duration : 3 hrs.
Dose : mentioned above |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
In this randomized double-blinded clinical trial, patients between 18 and 55 years old, American Society of Anesthesiologist (ASA) grade I and II of either gender undergoing elective lower limb surgeries are to be selected. |
|
| ExclusionCriteria |
| Details |
ASA more than grade II Patients. Poorly controlled Diabetes mellitus, neuromuscular, hepatic, adrenal gland abnormality or major renal disease. Known allergy to amide local anesthetics, dexmedetomidine or fentanyl. Patients using steroids, alpha-2 receptor antagonists and calcium channel blocker
Contraindication to spinal anesthesia (e.g. patient refusal, coagulation disorder, infection at the puncture site and tight valvular heart lesion) |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in terms of Block (Motor + Sensory) strength and time by adding two different medicines (dexmedetomidine and fentanyl) to a spinal anesthetic (bupivacaine) for surgeries on the lower legs. |
at baseline, at 1 hr, 2 hr, 3 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the haemodynamics between two groups
2. To compare post-operative pain by VAS score
3. To compare post-operative sedation score
4. To analyse complications, if any on adding these adjuncts. |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="153"
Sample Size from India="153"
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)
|
26/08/2024 |
| 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 use of adjuvants may reduce the nature of complications and improve the duration of the anesthetic effect. Some commonly used adjuvants are opioids, ketamine, neostigmine, clonidine, and dexmedetomidine. Lower limb surgeries could be performed under local, neuroaxial and general anesthesia, but neuroaxial block is the preferred method. Spinal block/ subarachnoid block is a relatively safe anesthetic method, it has rapid onset, deep block, lower risk of infection, preservation of mental status, normal airway reflexes and is cost effective. However, post-operative pain is an important problem as the used drugs have limited duration of effect; so the post-operative analgesic administration is necessary. Administrating the combinations of other classes of analgesics with local anesthetics has used to increase the duration and reduce side effects of analgesia [3]. Clonidine and dexmedetomidine are two α2 agonists affecting via pre- and post-synaptic α2 receptors [4]. Dexmedetomidine is an α2-adrenergic receptor (α2-AR) agonist. When administered intrathecaly, the time of onset of its action 5-10min peak effect at 15-30 min, duration of action is 2 hours after bolus injection. It prolongs the duration of both sensory and motor blockade induced by local anesthetics irrespective of the route of administration (e.g., epidural [3], caudal [4], or spinal [5]). When given intrathecally, it acts at the spinal and supraspinal levels. It activates α2-AR in the spinal cord, reducing transmission of nociceptive signals, inhibiting substance P’s release, and contributing to their analgesic action, and has a significant opioid-sparing effect [6]. At the supraspinal level, it binds to the presynaptic α2-ARs in locus ceruleus, producing sedation and anxiolysis; postsynaptic activation in CNS inhibits sympathetic activity leading to a decrease in heart rate and blood pressure. Rapid administration of dexmedetomidine infusion(loading Dose) may cause transient hypertension mediated by peripheral α2B-adrenoreceptor vasoconstriction [7].
Fentanyl is primarily a μ-receptor agonist. When administered intrathecally, the time to onset of its action is 1-3 minutes and the duration of action is 30-60 min. The significant advantage of "selective spinal analgesia" by fentanyl lies in the absence of sympathetic blockade and postural hypotension, potentially allowing early ambulation of the patient and avoidance of cardiovascular collapse or convulsions, which are major complications of a spinal anesthetic blockade. It has improved spinal anesthesia and reduced the anesthetic drug related side effects including pruritus, nausea and vomiting [8]. Dexmedetomidine and fentanyl have been used as adjuvant to local anesthetics in different surgeries to provide superior analgesia and to improve the duration of the block [9,10,11]. One study on lower limbs surgery showed a better efficacy with dexmedetomidine [12]. In this study, we aim to compare the efficacy of dexmedetomidine and fentanyl added to intrathecal bupivacaine in orthopedic procedures in lower limbs in terms of onset and duration of Motor Block. Lacunae in |