| CTRI Number |
CTRI/2024/02/062187 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Optimal dose of dexmedetomidine as an adjuvant to ropivacaine 0.75% with dextrose 80mg used in spinal anesthesia in patients undergoing lower abdominal and lower limb surgeries |
|
Scientific Title of Study
|
Optimal dose of intrathecal dexmedetomidine as an adjuvant to hyperbaric ropivacaine in subarachnoid block in patients undergoing lower abdominal and lower limb 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 Abhisheak Raveendran |
| Designation |
Post Graduate / Junior Resident |
| Affiliation |
Vinayaka Missions Medical College, Karaikal |
| Address |
Department of Anaesthesiology,
Vinayaka Missions Medical College, Keezhakasakudy Medu, Kottucherry Post,
Karaikal
PONDICHERRY
609609
India |
| Phone |
9941078403 |
| Fax |
|
| Email |
rabhisheak91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Cheran |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Medical College, Karaikal |
| Address |
Department of Anaesthesiology,
Vinayaka Missions Medical College, Keezhakasakudy Medu, Kottucherry Post,
Karaikal
PONDICHERRY
609609
India |
| Phone |
9443144652 |
| Fax |
|
| Email |
anscheran.k73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhisheak Raveendran |
| Designation |
Post Graduate / Junior Resident |
| Affiliation |
Vinayaka Missions Medical College, Karaikal |
| Address |
Department of Anaesthesiology,
Vinayaka Missions Medical College, Keezhakasakudy Medu, Kottucherry Post,
Karaikal
PONDICHERRY
609609
India |
| Phone |
9941078403 |
| Fax |
|
| Email |
rabhisheak91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Abhisheak Raveendran (Self) |
| Vinayaka Missions Research Foundation,
Vinayaka Missions Medical College,
Karaikal |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Research Foundation |
| Address |
Vinayaka Missions Medical College,Keezhakasakudy Medu, Kottucherry Post,Karaikal,
Pondichery - 609609 |
| 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 Abhisheak Raveendran |
Vinayaka Missions Medical College and hospital |
Keezhakasakudy Medu, Kottucherry Post
Karaikal
PONDICHERRY |
9941078403
rabhisheak91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee - Vinayaka Missions Medical College and hospital |
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 |
Group C (Control) |
A drug volume of 3.2ml containing 3ml of hyperbaric ropivacaine hydrochloride (7.5mg per ml) along with 0.2ml of NS added to ropivacaine given intrathecally 10 mins before start of the surgery for subarachnoid block |
| Intervention |
Group D1 (dexmedetomidine 5mcg) |
A drug volume of 3.2ml containing 3ml of hyperbaric ropivacaine hydrochloride (7.5mg per ml) along with dexmedetomidine (available as 100mcg per ml) 5mcg and rest NS added to ropivacaine given intrathecally 10 mins before start for subarachnoid block. |
| Intervention |
Group D2 (dexmedetomidine 10mcg) |
A drug volume of 3.2ml containing 3ml of hyperbaric ropivacaine hydrochloride (7.5mg per ml) along with dexmedetomidine (available as 100mcg per ml) 10mcg and rest NS added to ropivacaine given intrathecally 10 mins before start for subarachnoid block. |
| Intervention |
Group D3 (dexmedetomidine 15mcg) |
A drug volume of 3.2ml containing 3ml of hyperbaric ropivacaine hydrochloride (7.5mg per ml) along with dexmedetomidine (available as 100mcg per ml) 15mcg and rest NS added to ropivacaine given intrathecally 10 mins before start for subarachnoid block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients scheduled for elective lower abdominal and lower limb surgeries under subarachnoid block in VMMCH, Karaikal.
2) Patients of American Society of Anaesthesiologists (ASA) physical status I and II |
|
| ExclusionCriteria |
| Details |
1) Patients allergic to any of the drugs used
2) Patients having any absolute contraindications for spinal anesthesia such as patient not willing raised intracranial pressure, severe hypovolemia, bleeding diathesis, local infection and cardiac respiratory, and CNS diseases
3) Patients having hypertension
4) Patients with obesity more than 30kg per meter square
5) Patient with height less than 150cms
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Total duration of analgesia and Post-operative analgesia of intrathecal dexmedetomidine as an adjuvant to hyperbaric ropivacaine in subarachnoid block in patients undergoing lower abdominal and lower limb surgeries |
Time of drug given to 10th hour of postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare
1)Onset of sensory blockade
Onset and duration of motor blockade
2)Hemodynamic changes such as hypotension and bradycardia
3)Side effects such as pruritus, nausea and vomiting, shivering, urinary retention, and respiratory depression. |
time of drug given to 10th hour of postoperative period |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
06/02/2024 |
| 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
|
Introduction: Subarachnoid block is the most commonly performed block for lower abdominal, perineum and lower limb surgery. Many adjuncts like clonidine, fentanyl, ketamine, tramadol, neostigmine, magnesium sulphate, etc. have been used to prolong motor and sensory block, haemodynamic stability and reduced demand for rescue analgesics in first 24 hours. Dexmedetomidine is a more selective alpha 2 adrenoceptor agonist and has recently been widely used as an adjuvant to intrathecal local anaesthesia.
Advantages/benefits that would accrue out of the research: Intrathecal dexmedetomidine significantly prolongs analgesic effect thus reducing higher doses of local anaesthetic agents, Reduces the requirement of post-operative analgesic, Optimal dose of intrathecal dexmedetomidine prevents adverse effects such as hypotension and bradycardia which is most reported intraoperative and postoperative period Study procedure: After getting approval from the ethics and research committee, after applying inclusion and exclusion criteria, informed written consent is obtained, and patients are randomly divided into five groups. All patients received a drug volume of 3.2ml containing 3ml of hyperbaric ropivacaine hydrochloride (7.5mg/ml). The study groups received dexmedetomidine (available as 100mcg/1ml) 5mcg (group D1), 10mcg (group D2) and 15mcg (group D3) in an identical volume of 0.2ml, diluted with normal saline and added to ropivacaine in the same syringe. The control group (Group C) received 0.2ml of NS added to ropivacaine. Insulin syringe (1ml) was used for measuring fluids<1ml. After arrival into the operation theatre, standard monitor was attached. ECG, pulse oximetry and non-invasive blood pressure were monitored and baseline values were recorded. An intravenous line was secured. With the patient in sitting position, under all aseptic conditions, lumbar puncture was performed at L2-3 or L3-4 intervertebral space with 25G Quincke spinal needle until free flow of cerebrospinal fluid is seen. The drug is injected intrathecally using a 5ml Syringe. Time of onset and duration of Motor blockage (using bromage scale), Time of onset and duration of Sensory blockage (using pin-prick method), Time to first rescue analgesia, Intra-operative systolic/diastolic blood pressure, heart rate are recorded. In postoperative period, Patient vitals and pain score is recorded using VAS scale are recorded. |