| CTRI Number |
CTRI/2025/01/079087 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing of Clonidine and Dexmedetomidine for Spinal Anesthesia in Lower Abdominal Surgery patients |
|
Scientific Title of Study
|
Comparative evaluation of Dexmedetomine and Clonidine as an adjuvant to Ropivacaine (H) in subarachnoid block for infraumbilical 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 Kaustuv Das |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
JNMC CAMPUS, Department of Anaesthesiology , SAWANGI(MEGHE), WARDHA ,MAHARASHTRA ,INDIA 442001
Jawaharlal Nehru Medical College, Sawangi (Meghe), and Datta Meghe Institute Of Higher Education And Research
Wardha
MAHARASHTRA
422001
India |
| Phone |
9830129119 |
| Fax |
|
| Email |
kaustuv_d@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashree Sen |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Anaesthesia
Jawaharlal Nehru Medical College , Sawangi (Meghe) and Datta Meghe Institute Of Higher Education And Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
9813061192 |
| Fax |
|
| Email |
jayashree_sen@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayashree Sen |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Anaesthesia
Jawaharlal Nehru Medical College , Sawangi (Meghe) and Datta Meghe Institute Of Higher Education And Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
9813061192 |
| Fax |
|
| Email |
jayashree_sen@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra , India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research, Sawangi ( Meghe) , Wardha-442001 |
| 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 Kaustuv Das |
Acharya Vinoba Bhave Rural Hospital |
In patient department ,
Department of Aanesthesiology ,Acharya Vinoba Bhave Rural Hospital , Sawangi (Meghe)
Wardha
Maharashtra
Wardha
MAHARASHTRA |
9830129119
kaustuv_d@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Institutional Ethics Commitee |
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 |
3.4ml of 0.5% ropivacaine(heavy) and 30mcg of clonidine |
| Intervention |
Dexmedetomidine |
3.4 ml of 0.5% ropivacaine (heavy) and 10 mcg of dexmedetomidine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.) Adult patients between the ages of 18 and 60 years,
2.) Patients scheduled for elective infra-umbilical surgeries,
3.) American Society of Anesthesiologists (ASA) physical status I or II,
4.) Surgery duration ranging between one and three hours.
|
|
| ExclusionCriteria |
| Details |
1.) Allergic reactions to any of the research drugs.
2.) Recognized contraindications to spinal anesthesia,
3.) Significant cardiovascular disease or a history of cardiac arrhythmias,
4.) Pregnant females,
5.) Coagulopathy or hemorrhagic conditions,
6.) Surgery duration less than one hour or more than three hours
7.) Incapacity to give informed consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset of sensory and motor blockade
The level of sedation
Hemodynamic parameters
|
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
31/01/2025 |
| 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
|
Due to its quick onset and efficiency, the subarachnoid block is a popular anesthetic option for infra umbilical procedures. Research on administering adjuvants with local anesthetics in subarachnoid blocks is ongoing, and two drugs that show promise for enhancing postoperative analgesia and sensory and motor blockade are clonidine and dexmedetomidine Objective To compare the safety and effectiveness of Dexmedetomidine and Clonidine as adjuvants to Ropivacaine in subarachnoid blocks for infra-umbilical procedures. Methods A randomization process will be used to divide sixty adult patients scheduled for elective infra umbilical procedures into two groups: Group C will receive Clonidine with Ropivacaine. In contrast, Group D will receive Dexmedetomidine with Ropivacaine. Intensive intraoperative and postoperative monitoring, vital sign assessments, and preoperative evaluations will all be carried out. A comparison of the two groups will be conducted, and parameters including the duration of postoperative analgesia, hemodynamic stability, sensory and motor blockade period, and adverse events will be evaluated. Conclusion As adjuvants in subarachnoid blocks for infra umbilical procedures, the research will show clonidine and dexmedetomidine efficacy and safety profiles. The selection of adjuvants may be contingent upon particular therapeutic needs and patient attributes. The study findings will focus on improving patient outcomes, comfort, and safety while improving anesthesia techniques for non traumatic surgery. |