| CTRI Number |
CTRI/2024/03/064794 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| 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
|
COMPARISON OF MEDICINES TO STUDY EFFECTS LIKE BLOOD PRESSURE, HEART RATE VARIATIONS AND SENSORY AND MOTOR CHARACTERISTICS IN SPINAL ANAESTHESIA |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF INTRATHECAL DEXMEDETOMIDINE VERSUS CLONIDINE AS ADJUVANT TO 0.75% HYPERBARIC ROPIVACAINE IN INFRA UMBILICAL SURGERIES :A RANDOMISED CLINICAL TRIAL |
| 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 Soumya Patted |
| Designation |
Post graduate resident |
| Affiliation |
Bangalore Medical College and Research Institute, RGUHS University, Karnataka |
| Address |
Department of Anesthesiology Banglore Medical College and Research institute
Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
8884839682 |
| Fax |
|
| Email |
soumyacp121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samudyatha T J |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anesthesiology Banglore Medical College and Research institute
Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9686216626 |
| Fax |
|
| Email |
drsamudyatha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samudyatha T J |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anesthesiology Banglore Medical College and Research institute
Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9686216626 |
| Fax |
|
| Email |
drsamudyatha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute ,
Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka, India PIN -560002. |
|
|
Primary Sponsor
|
| Name |
Dr Soumya Patted |
| Address |
Bangalore Medical College and Research Institute
Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002 |
| 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 Soumya Patted |
Bangalore Medical College and Research Institute |
Department of Anesthesiology
Bangalore
KARNATAKA |
8884839682
soumyacp121@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M859||Disorder of bone density and structure, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.75% hyperbaric Ropivacaine 3ml + Clonidine 50 mcg
|
After adequate preoperative evaluation, patient will be brought inside operation theatre.Blood pressure, ECG leads, pulse oximeter will be connected. Intravenous fluids will be started. Patient will be made to sit and spinal anaesthesia will be given in L3-L4 intervertebral space with 25 gauge Quincke spinal needle using 3 ml 0.75% hyperbaric ropivacaine and clonidine 50 mcg. Intrathecal drug will be given over 10-15 seconds and patient will be made to lie supine immediately after giving drug and that time will be taken as 0.
Drug will be given only once and it will take 10-15 seconds to administer.Route of administration is intrathecal( subarachnoid space) |
| Intervention |
0.75% hyperbaric Ropivacaine 3ml + dexmedetomidine 5 mcg |
After adequate preoperative evaluation, patient will be brought inside operation theatre.Blood pressure, ECG leads, pulse oximeter will be connected. Intravenous fluids will be started. Patient will be made to sit and spinal anaesthesia will be given in L3-L4 intervertebral space with 25 gauge Quincke spinal needle using 3 ml 0.75% hyperbaric ropivacaine and dexmedetomidine 5 mcg. Intrathecal drug will be given over 10-15 seconds and patient will be made to lie supine immediately after giving drug and that time will be taken as 0.
Drug will be given only once and it will take 10-15 seconds to administer.Route of administration is intrathecal( subarachnoid space) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age group 18-60 years undergoing infraumbilical surgeries under supbarchnoid block.
2. Patients willing to give written informed consent
3. Patients belonging to ASA I and II |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To compare the block characteristics of intrathecal Dexmedetomidine versus Clonidine as an adjuvant to 0.75% Hyperbaric Ropivacaine in terms of the onset and duration of sensory block and motor block
2) To compare the duration of post operative analgesia |
From time of intrathecal injection to every 30 seconds till the loss of sensation at T10 dermatomal level and thereafter at 2 mins intervals till the maximum level of sensory blockade is achieved and subsequently at 30 mins interval until complete recovery.
From time of intrathecal injection every 1 minute for the first 5 min, then at 5-min intervals for next 30 minutes and at every 30 minutes intervals until complete resolution of motor anesthesia.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to compare effects of dexmedetomidine and clonidine on hemodynamic parameters, sedation and adverse effects.
|
Before spinal anaesthesia, after spinal anaesthesia every 2 minutes for first 10 minutes, then every 5 minutes for 30 minutes, thereafter every 10 minutes till end of surgery .
Immediate post operative period, every 2 hours for 6 hours, 12 hours and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
06/04/2024 |
| 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="30" |
|
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
|
70 patients will be randomly grouped by computer generated numbers and assigned to one of the two groups: Group RD (n=35) will receive 0 .75% hyperbaric Ropivacaine 3 ml + Dexmedetomidine 5 mcg Group RC (n=35) will receive 0 .75% hyperbaric Ropivacaine 3 ml + Clonidine 50 mcg intrathecally. Data will be collected in the case record proforma meeting the objectives of the study. Pre anaesthetic evaluation will be done for each patient and written informed consent will be taken. All patients will be fasted 8 hours for solid food and 4 hours for clear fluids. Intravenous line will be obtained with 18-gauge cannula and will be preloaded with Ringer lactate at 15 ml/kg body weight about 20 minutes before anaesthesia. Patients will be monitored with pulse oximetry( spO2), electrocardiography (ECG), non- invasive blood pressure (NIBP).Under aseptic precautions lumbar puncture will be performed at the level of L3- L4 intervertebral space through a midline approach using 25 G Quincke’s spinal needle and study drug will be injected after confirmation of needle tip in the subarachnoid space by clear and free flow of cerebrospinal fluid. Patients will be randomly divided into 2 groups by computer generated random sequence table (www.randomization.com)namely Group RD and Group RC in a sealed envelope with labelled syringe. Drug will be given by anaesthetist not involved in study.Intrathecal injection will be given over approximately 10-15seconds. Patients wil be made to lie in supine position immediately. All the things will be kept ready for general anesthesia if needed. Table will be kept in neutral position. All the patients wil be given oxygen by Hudson mask at 6 Litres/minute. The time of intrathecal injection will be noted and taken as 0 minute. Patients will be monitored with ECG ,NIBP ,SPO2 and respiratory rate at regular intervals of every 5 minutes and continued in the post-operative period.When Visual Analogue Scale(VAS)of >4 or when patient desires rescue analgesic (Paracetamol)will be given Sensory blockade will be tested using pin prick method with a blunt 27 Gauge hypodermic needle along midclavicular line bilaterally every 30 seconds till the loss of sensation at T10 dermatomal level and thereafter at 2 mins intervals till the maximum level of sensory blockade is achieved and subsequently at 30 mins interval until complete recovery. Motor block will be assessed by using a Modified Bromage Scale every 1 minute for the first 5 min, then at 5-min intervals for next 30 minutes and at every 30 minutes intervals until complete resolution of motor block.Parameters assessed will be BP, HR, SpO2, RR , onset ,duration and maximum level of sensory and motor block , duration of analgesia and sedation, rescue analgesic requirement. All these parameters will beonitered both intra and postoperative period |