| CTRI Number |
CTRI/2024/08/072850 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Clonidine With Dexmedetomidine As Premedicant to Spinal 5 milligrams per ml Heavy Levobupivacaine for Prolonging Postop Analgesia |
|
Scientific Title of Study
|
Clonidine Versus Dexmedetomidine As Premedication to Intrathecal 0.5percent Levobupivacaine Heavy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renganathan Sockalingam |
| Designation |
Associate professor |
| Affiliation |
Velammal Hospital and Medical College |
| Address |
Room number 2,Department of Anesthesia, near MOT Complex, Velammal medical college,
velammal Village, Madurai Tuticorin ring Road, Anuppanadi , Madurai,
Tamil Nadu 625009
Madurai
TAMIL NADU
625009
India |
| Phone |
95000025879 |
| Fax |
|
| Email |
renganathansockalingam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Radhakrishnan |
| Designation |
Junior Resident |
| Affiliation |
Velammal Hospital and Medical College |
| Address |
Room number 2,Department of Anaesthesia,near MOT Complex, velammal medical college, velammal Village, Madurai
Tuticorin ring Road, Anuppanadi ,Madurai, Tamil Nadu 625009
Madurai
TAMIL NADU
625009
India |
| Phone |
95000025879 |
| Fax |
|
| Email |
radhakrishnan04562@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR.T.NIRMALA DEVI |
| Designation |
Professor |
| Affiliation |
Velammal Hospital and Medical College |
| Address |
Room number 2,Department of
anaesthesia ,near MOT
Complex, velammal medical college, velammal Village, Madurai Tuticorin ring Road, Anuppanadi ,Madurai, Tamil Nadu 625009
Madurai
TAMIL NADU
625009
India |
| Phone |
9842152813 |
| Fax |
|
| Email |
tnirmalaroja@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Velammal medical college and hospital, Room number 2,Department of anaesthesia,near MOT
Complex,velammal medical college,velammal Village, Madurai Tuticorin ring Road, Anuppanadi, Madurai, Tamil Nadu INDIA,625009
|
|
|
Primary Sponsor
|
| Name |
velammal medical college and hospital |
| Address |
Velammal Village, Madurai - Tuticorin, Airport-Mattuthavani Ring Rd, Chinthamani, Tamil Nadu 625009 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Radhakrishnan M |
Velammal Medical college and hospital |
Room number 2,Department of anaesthesia,near MOT
Complex, velammal medical college, velammal Village, Madurai Tuticorin ring Road, Anuppanadi , Madurai, Tamil Nadu INDIA 625009
Madurai
TAMIL NADU |
8248621252
radhakrishnan04562@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| velammal medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.75 microgram per kilogram dexmedetomidine as a premedication to 0.5% intrathecal levobupivacaine |
0.75 microgram per kilogram dexmedetomidine will be administered intravenously over 15 minutes in 100ml NS followed by spinal anesthesia with 3mL of 0.5% hyperbaric levobupivacaine.
|
| Comparator Agent |
1.5 micrograms per kg clonidine as premedication to intrathecal 0.5% heavy levobupivacaine |
1.5 microgram per kg clonidine will be administered intravenously over 15 minutes in 100ml NS followed by spinal anesthesia with 3mL of 0.5% hyperbaric levobupivacaine.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.All adult patients with ASA physical status I or II
2.either sex
3.18–60 years age
4.48–90 kg weight, 151–180 cm height and body mass index (BMI) between 20 and 35 kg/m2
|
|
| ExclusionCriteria |
| Details |
We excluded the patients
1.with known hypersensitivity to LA,
2.infection at the injection site
3.history of bleeding disorders or on anticoagulants,
4.pregnancy, anatomical abnormality,
and any comorbid condition such as preexisting peripheral neuropathy or neurological deficit, cerebrovascular accidents, endocrine, severe hepatic and renal dysfunction, chronic
obstructive pulmonary disease, diabetes, sepsis, heart blocks, or dysrhythmias. Patients on tranquilizers, hypnotics, sedatives, and other psychotropic drugs and drug addicts to
opium or alcohol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
onset of sensory block
Time taken to achieve highest level
onset of motor blockade
Recovery of sensory block
Recovery of motor block
Duration of analgesia
|
Results will be assessed between 4 and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Heart rate
Mean arterial pressure |
secondary parameters were noted before premedication,2 mins after premedication,60 seconds after dural puncture,15mins,20 mins,25 mins,30 mins,40 mins,50 mins,60 mins,70 mins,80 mins,90 mins,120 mins, and 180 mins after dural puncture |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/09/2024 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Spinal anesthesia is a reliable and safe technique in lower
limb and lower abdominal surgeries.[1]
It is favorable when
general anesthesia is contraindicated or in patients in whom
anatomical abnormalities may make tracheal intubation
very difficult.[2]
Many techniques and drug regimens, with
partial or greater success, have been tried from time to time
to alleviate anxiety and prolong postoperative analgesia
during regional anesthesia. Several adjuvants such
as midazolam, opioids, and α2-adrenoceptor agonists have
been studied in this regard. When used as adjuvant to regional anesthesia, alpha-2-adrenoceptor agonists have both analgesic and soothing properties.[ Clonidine and dexmedetomidine are the two most used drugs. Oral, spinal, and epidural are the
various routes of administration of these drugs to prolong
the duration of spinal anesthesia.[5-7]
They prolong the
duration of both motor and sensory blockade and also
postoperative analgesia by potentiating the effect of local
anesthesia Both spinal and supraspinal mechanisms have been
proposed to explain their action. In the spinal cord,
stimulation of α-adrenoreceptors at the substantia
gelatinosa of the dorsal horn of the spinal cord leads
to inhibition of nociceptive neurons. Stimulation of the
adrenoreceptors in the locus coeruleus results in sedation
and anxiolysis and also terminates propagation of pain
signals leading to analgesia.[10]
Clonidine is a selective partial agonist for alpha-2-
adrenoreceptors used intrathecally, with a well-established
record of efficacy and safety.[11]
Dexmedetomidine is a
highly selective alpha-2-adrenoreceptor agonist with the
alpha-2: alpha-1 binding ratio of 1620: 1 when compared
with 220:1 for clonidine which is 8–10 times higher than
that of clonidine.[12]
The prolongation of spinal anesthesia
after intravenous (IV) administration of dexmedetomidine
and clonidine can be explained by the supraspinal effects
of these drugs.[13,14]
There are limited studies to show
the dose equivalence of these two drugs; however, some
studies showed that the dose of clonidine is 1.5–2 times
higher than the dose of dexmedetomidine.[15,16]
Therefore, we designed this prospective, randomized, study to compare the efficacy of the IV
infusion of clonidine 0.75 µg/kg vs. dexmedetomidine
0.75 µg/kg on spinal block characteristics as premedication
to intrathecal 0.5% hyperbaric levobupivacaine in patients
undergoing various lower limb and lower abdominal
surgeries. |