| CTRI Number |
CTRI/2024/03/064274 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare and identify which medication among dexmedetomidine and fentanyl as additive to hyperbaric ropivacaine for spinal anaesthesia in patients undergoing removal of uterus surgery is safe and effective. |
|
Scientific Title of Study
|
Comparing efficacy and safety of Intrathecal adjuvants Dexmedetomidine and Fentanyl with hyperbaric Ropivacaine in patients undergoing elective total abdominal hysterectomy surgery: A Randomized, Double-Blind, Clinical study.
|
| 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 M Vivekanandh |
| Designation |
Postgraduate |
| Affiliation |
karpaga vinayaga institute of medical sciences and research centre |
| Address |
Department of Anaesthesiology, karpaga vinayaga medical college hospital, karpaga vinayaga institute of medical sciences and research centre, chinnakolambakkam, madhurandhagam, chengalpattu
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9790228879 |
| Fax |
|
| Email |
peruvivan1711@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sufala Viswasrao |
| Designation |
Professor |
| Affiliation |
karpaga vinayaga institute of medical sciences and research centre |
| Address |
Department of Anaesthesiology, karpaga vinayaga medical college hospital, karpaga vinayaga institute of medical sciences and research centre, chinnakolambakkam, madhurandhagam, chengalpattu
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9551403203 |
| Fax |
|
| Email |
vivu94unplugged@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Vivekanandh |
| Designation |
Postgraduate |
| Affiliation |
karpaga vinayaga institute of medical sciences and research centre |
| Address |
Department of Anaesthesiology,
karpaga vinayaga medical college hospital, karpaga vinayaga institute of medical sciences & research centre, chinnakolambakkam maduranthagam, chengalpattu
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9790228879 |
| Fax |
|
| Email |
peruvivan1711@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karpaga vinayaga institute of medical sciences and research centre |
|
|
Primary Sponsor
|
| Name |
Dr M Vivekanandh |
| Address |
karpaga vinayaga institute of medical sciences and research centre, chinnakolambakkam, madhurandhagam, chengalpattu |
| Type of Sponsor |
Other [Self] |
|
|
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 M Vivekanandh |
Karpaga vinayaga medical college hospital |
operation theatre complex, department of anaesthesiology, karpaga vinayaga institute of medical sciences and research centre,
chinnakolambakkam, madhurandhagam, chengalpattu
Kancheepuram
TAMIL NADU |
9790228879
peruvivan1711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INTERNAL ETHICS COMMITTEE KIMS-RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dexmedetomidine |
dexmedetomidine dose - 10 mcg (0.1ml) diluted with 0.4ml of normal saline.
route of administration - intrathecal route.
frequency - single time administration
as an adjuvant to hyperbaric ropivacaine 0.75% - 3ml. |
| Comparator Agent |
fentanyl |
fentanyl dose - 25 mcg (0.5ml),
route of administration - intrathecal route. frequency - single time administration as an adjuvant to hyperbaric ropivacaine 0.75% - 3ml. |
| Intervention |
intrathecal administration of adjuvants dexmedetomidine and fentanyl to hyperbaric ropivacaine |
to compare the effect and safety of dexmedetomidine and fentanyl as an intrathecal adjuvant to hyperbaric ropivacaine in patients undergoing total abdominal hysterectomy |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1)patients belonging to ASA class I & class II.
2)patients without any severe comorbid diseases. |
|
| ExclusionCriteria |
| Details |
1)Patients having any absolute contraindications for spinal anaesthesia such as patient not willing, raised intracranial pressure, severe hypovolemia, bleeding diathesis, local infection and cardiac, respiratory, and CNS diseases.
2)Pregnant females and those with chronic diseases such as diabetes, hypertension,renal dysfunction, liver disorders and cardiac abnormalities.
3)Patients with body mass index >30 kg/m².
4)Patients shorter than 150 cm.
5)Patients allergic to any of the study drugs.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparison of Onset and duration of sensory blockade and motor blockade provided by adjuvants Dexmedetomidine and Fentanyl, given with intrathecal Hyperbaric Ropivacaine. |
comparison of Onset and duration of sensory blockade and motor blockade provided by adjuvants Dexmedetomidine and Fentanyl, given with intrathecal Hyperbaric Ropivacaine at baseline,at 5 minutes, then every 15 minutes till end of the surgery, and in the postoperative period till blockade regression. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Complete sensory & motor blockade attained & time taken for the same.
2)Total duration of analgesia.
3)Rescue analgesia.
4)The haemodynamic changes such as hypotension & bradycardia.
5)Side effects such as pruritus, nausea & vomiting, shivering.
|
1)Complete sensory & motor blockade attained & time taken for the same at 5 minutes, then at every 15 minutes till blockade regression.
2)Total duration of analgesia in the postoperative period.
3)Rescue analgesia.
4)The haemodynamic changes such as hypotension & bradycardia occuring intraoperatively at every 15 minutes.
5)Side effects such as pruritus, nausea & vomiting, shivering occuring at the end of surgery.
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/03/2024 |
| Date of Study Completion (India) |
14/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
The primary purpose of the protocol is to collect basic details of the patient, record and monitor the vital signs, fill in the information regarding the primary and secondary objectives of the study after the intrathecal drug administration. Objective of this study is to compare the effects and safety of dexmedetomidine as an intrathecal adjuvant to hyperbaric ropivacaine and fentanyl as an intrathecal adjuvant to hyperbaric ropivacaine. |