| CTRI Number |
CTRI/2024/07/070283 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study will be done on patients coming for elective lower abdominal surgeries and effects of four different doses of dexmedetomidine with hyperbaric ropivacaine in spinal anaesthesia will be compared |
|
Scientific Title of Study
|
Comparison of effects of different doses of dexmedetomidine as an intrathecal adjuvant to hyperbaric ropivacaine in lower abdominal surgeries : a prospective randomised controlled 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 |
Simran Naval |
| Designation |
Postgraduate, Dept of Anesthesiology |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, first floor, new Stone building, KR hospital, Mysore Medical college and research institute, Irwin road, Mysuru, Karnataka
Department of Anaesthesiology, first floor, new stone building, KR Hospital,Mysore Medical college and research institute,Irwin road,Mysuru, Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
8618368050 |
| Fax |
|
| Email |
naval.sim24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lakshmi Priya |
| Designation |
Assistant Professor, Dept of Anaesthesiology, MMCRI |
| Affiliation |
Mysore Medical College And Research Institute |
| Address |
Department of Anaesthesiology, first floor, new Stone building, KR hospital, Mysore Medical college and research institute, Irwin road, Mysuru, Karnataka
Department of Anaesthesiology, first floor, new Stone building, KR hospital, Mysore Medical college and research institute, Irwin road, Mysuru, Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
9845099554 |
| Fax |
|
| Email |
c7drpriya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lakshmi Priya |
| Designation |
Assistant Professor, Dept of Anaesthesiology, MMCRI |
| Affiliation |
Mysore Medical College And Research Institute |
| Address |
Department of Anaesthesiology, first floor, new Stone building, KR hospital, Mysore Medical college and research institute, Irwin road, Mysuru, Karnataka
Department of Anaesthesiology, first floor, new Stone building, KR hospital, Mysore Medical college and research institute, Irwin road, Mysuru, Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
9845099554 |
| Fax |
|
| Email |
c7drpriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mysore Medical College and Research Institute, Irwin road, Mysore, Karnataka state, India pin code 570001 |
|
|
Primary Sponsor
|
| Name |
Simran Naval |
| Address |
Mysore Medical college and research institute, Irwin road, next to railway station, Mysuru, Karnataka state, India, pin code 570001 |
| 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 |
| Simran Naval |
mysore medical college |
department of anaesthesia, first floor, stone building, KR hospital, mysore
Mysore
KARNATAKA |
8618368050
naval.sim24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
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 |
Comparison of different doses of dexmedetomidine with intrathecal hyperbaric ropivacaine |
Comparing the effects of four different doses of Dexmedetomidine that is dose of5 mcg, 10mcg, 15mcg, 20mcg as intrathecal adjuvant to hyperbaric ropivacaine in elective lower abdominal surgeries under spinal Anesthesia given once and duration of post operative analgesia evaluated
Frequency 1 time
Duration up to first rescue analgesia |
| Intervention |
Four different doses of Dexmedetomidine ( 5 mcg, 10mcg, 15mcg,20mcg )as intrathecal adjuvant to hyperbaric ropivacaine in elective lower abdominal surgeries |
Comparing the effects of four different doses of Dexmedetomidine that it 5 mcg, 10mcg, 15mcg,20mcg as intrathecal adjuvant to hyperbaric ropivacaine in elective lower abdominal surgeries under spinal Anesthesia given once and duration of post operative analgesia evaluated
Frequency 1 time
Duration up to first rescue analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All ASA Grade 1 and 2, patients scheduled for elective lower abdominal surgery under subarachnoid block |
|
| ExclusionCriteria |
| Details |
Patients with hypertension, diabetes, spinal deformity, coagulation disorder, drug allergy, cardiovascular , respiratory or neurological disorders, pregnant patients, height less than 140cm, BMI more than 30kg per meter square, impaired liver and renal function tests, ASA Grade 3, 4, local skin infections |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To asses onset and duration of sensory blockade from the time of drug adminitration
2. Maximum sensory level achieved and time taken for it
3.Time taken for 2 segment sensory regression
4. Onset and duration of motor blockade
5. Total duration of post op analgesia |
1.To asses onset and duration of sensory blockade from the time of administration of drug
2. Maximum sensory level achieved and time taken for it
3.Time taken for 2 segment sensory regression
4. Onset and duration of motor blockade
5. Total duration of post op analgesia every hour till time of rescue analgesia.
Every outcome assessed every 30 seconds till 5 minutes, every 1 minuthe till next 10 minutes every 5 minutes till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in hemodynamic parameters and adverse effects |
24 hours after spinal anaesthsia |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
17/07/2024 |
| 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="2"
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
|
This is a prospective randomized controlled study to compare the effects of different doses of dexmedetomidine that is 5, 10, 15 and 20mcg as an intrathecal adjuvant to hyperbaric ropivacaine in elective lower abdominal surgeries. Total sample size id 100, divided into 5 groups including the control group. Primary objective is to asses the onset and duration of sensory blockade, time for 2 segment sensory regression, onset and duration of motor blockade and time of rescue analgesia. Secondary objective include monitoring of hemodynamics and adverse effects. |