| CTRI Number |
CTRI/2024/12/077858 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating dexmedetomidine and clonidine as enhancers of spinal anesthesia in patients undergoing lower abdominal surgery |
|
Scientific Title of Study
|
A prospective randomized double blind study to
compare effect of subcutaneous dexmedetomidine
versus clonidine as an adjuvant to spinal
anaesthesia in patients undergoing lower
abdominal 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 Veena Patodi |
| Designation |
Senior Professor |
| Affiliation |
JLN medical college and hospital, Ajmer |
| Address |
Department of anesthesia, new OT, first floor, JLN hospital, Kala bagh, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Patodi |
| Designation |
Senior Professor |
| Affiliation |
JLN medical college and hospital, Ajmer |
| Address |
Department of anesthesia, new OT, first floor, JLN hospital, Kala bagh, Ajmer, Rajasthan
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Patodi |
| Designation |
Senior Professor |
| Affiliation |
JLN medical college and hospital, Ajmer |
| Address |
Department of anesthesia, new OT, first floor, JLN hospital, Kala bagh, Ajmer, Rajasthan
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia, JLN medical college and hospital, Ajmer, Rajasthan 305001 |
|
|
Primary Sponsor
|
| Name |
JLN medical college and hospital |
| Address |
kala bagh, Ajmer, Rajasthan 305001 |
| 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 |
| Dr Ravi Shekhawat |
JLN medical college and hospital |
Department of anesthesia, new OT, first floor, JLN hospital, Kala bagh, Ajmer, Rajasthan 305001
Ajmer
RAJASTHAN |
09033190479
ravishekhawat9999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethecal committee Jawarlal Nehru medical college, Ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clonidine |
Group C - 30 patients will be given 1 microgram per kilogram of clonidine diluted up to 1 milliliter with
normal saline subcutaneously given with using 26 gauge half inch
hypodermic needle |
| Intervention |
Dexmedetomidine |
Group D - 30 patients will be given 0.5 microgram per kilogram of dexmedetomidine diluted up to 1 milliliter
with normal saline subcutaneously given with using 26 gauge half
inch hypodermic needle |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
-Age group between 20 and 70 years
-Body weight 40 to 80 kg.
- Patients belonging to ASA (American Society of anaesthesiologist) class-I and II.
- Patients undergoing various infraumbilical surgeries |
|
| ExclusionCriteria |
| Details |
-Patient’s refusal and uncooperative patients.
-Any known hypersensitivity or contraindication to bupivacaine , clonidine and
Dexmedetomidine.,
- Local pathology at the site of injection or disability limiting the performance of spinal
block.
- History of convulsion, altered coagulation profile, bleeding disorder, pre-existing
neurological deficit, surgeries in prone position , obstructive sleep apnea, thyroid
disorder, known allergy to bupivacaine, dexmedetomidine, clonidine.
-Patient with history of respiratory, cardiac, hepatic or renal disease (necessitating
classification in ASA Class III or above).
-Patients having a history of significant neurological, psychiatric, or neuromuscular
disorders. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of analgesia |
Baseline to 60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Onset and duration of sensory block.
- Onset and duration of motor block.
- The intraoperative hemodynamic variability ( haemodynamic parameters)
- Postoperative Visual analog scale (VAS) score
- Ramsay sedation scale
- Total analgesia requirement in 24 hour
-Adverse effects if any |
24 hours |
|
|
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)
|
20/12/2024 |
| 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="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 research proposal is titled, "A Prospective Randomized Double-Blind Study to Compare Effect of Subcutaneous Dexmedetomidine Versus Clonidine as an Adjuvant to Spinal Anaesthesia in Patients Undergoing Lower Abdominal Surgeries."
Key Aspects of the Dissertation Plan:
Objective: The primary objective is to compare the duration of postoperative analgesia when using subcutaneous dexmedetomidine versus clonidine as adjuvants to bupivacaine spinal anesthesia in patients undergoing lower abdominal surgeries. Secondary objectives include comparing onset and duration of sensory and motor block, intraoperative hemodynamic variability, postoperative Visual Analog Scale (VAS) score, Ramsay Sedation Scale, total analgesia requirement in 24 hours, and adverse effects.
Methodology: This will be a prospective, randomized, double-blind, comparative study involving 60 patients (30 in each group: dexmedetomidine, clonidine, and placebo). The study will be conducted at Jawaharlal Nehru Hospital and attached hospitals in Ajmer, India. Subcutaneous administration of the drugs will be used. Data analysis will be performed using SPSS software.
Ethical Considerations: The plan includes obtaining informed consent from patients or their guardians and approval from the college’s ethical committee. The rationale for the subcutaneous route is justified based on its advantages of similar efficacy to IV administration, with less hemodynamic instability and a prolonged effect.
Drugs Used: Hyperbaric bupivacaine (0.5%), dexmedetomidine (0.5 mcg/kg), and clonidine (1 mcg/kg) will be administered subcutaneously after subarachnoid block with bupivacaine.
Data Collection: The plan details the various parameters to be recorded, including sensory and motor block characteristics, pain scores using VAS, Ramsay Sedation Scale, hemodynamic parameters, and adverse effects.
In summary, this dissertation plan proposes a well-structured study to compare the efficacy and safety of subcutaneous dexmedetomidine and clonidine as adjuvants to spinal anesthesia for prolonging postoperative analgesia in patients undergoing lower abdominal surgeries. The plan outlines the methodology, ethical considerations, and statistical analysis to be employed in the study. |