| CTRI Number |
CTRI/2022/11/047374 [Registered on: 17/11/2022] Trial Registered Prospectively |
| Last Modified On: |
16/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between two drug combinations in spinal anaesthesia in below umbilical surgeries |
|
Scientific Title of Study
|
A Prospective Randomized Study Comparing Intrathecal Dexmedetomidine and Fentanyl as Adjuvants to Hyperbaric Ropivacaine in Infra Umbilical Surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SUPRIYA SHREE |
| Designation |
PG Anaesthesia |
| Affiliation |
Government Hospital, Gandhi Nagar, Jammu |
| Address |
Department of Anesthesia, Government Hospital, Gandhi Nagar, Jammu
Jammu
JAMMU & KASHMIR
180004
India |
| Phone |
09719153125 |
| Fax |
|
| Email |
shreesupriya25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANGEETA SINGH |
| Designation |
Senior Consultant |
| Affiliation |
Government Hospital, Gandhi Nagar, Jammu |
| Address |
Department of Anaesthesia, Government Hospital, Gandhi Nagar, jammu
Jammu
JAMMU & KASHMIR
180004
India |
| Phone |
9419139718 |
| Fax |
|
| Email |
sangeetajammu1965@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUPRIYA SHREE |
| Designation |
PG Anaesthesia |
| Affiliation |
Government Hospital, Gandhi Nagar, Jammu |
| Address |
Department of Anaesthesia, Government Hospital, Gandhi Nagar, Jammu
Jammu
JAMMU & KASHMIR
180004
India |
| Phone |
09719153125 |
| Fax |
|
| Email |
shreesupriya25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Hospital, Gandhi Nagar, Jammu |
|
|
Primary Sponsor
|
| Name |
Government Hospital |
| Address |
Gandhi Nagar, Jammu |
| Type of Sponsor |
Government funding agency |
|
|
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 Supriya Shree |
Government Hospital Gandhi Nagar |
Ground floor, Department of Anaesthesiology, Government Hospital,Gandhi Nagar, Jammu
Jammu
JAMMU & KASHMIR |
09719153125
shreesupriya25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMC, Jammu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
hyperbaric Ropivacaine alone |
2 ml of 0.75% hyperbaric ropivacaine with 0.5 ml of normal saline will be given intrathecally.Onset of sensory blockad,Maximum level of sensory blockade attained and the time taken for the same, Time for two-segment sensory regression,Onset and duration of motor blockade and Total duration of analgesia will be recorded |
| Comparator Agent |
Hyperbaric Ropivacaine plus Dexmedetomidine |
2 ml of 0.75% hyperbaric ropivacaine with dexmedetomidine 10 μg will be given intrathecally. Onset of sensory blockade, Maximum level of sensory blockade attained and the time taken for the same,Time for two-segment sensory regression, Onset and duration of motor blockade and Total duration of analgesia will be recorded
|
| Comparator Agent |
Hyperbaric Ropivacaine plus Fentanyl |
2 ml of 0.75% hyperbaric ropivacaine with fentanyl 25 μg will be given intrathecally.Onset of sensory blockad,Maximum level of sensory blockade attained and the time taken for the same, Time for two-segment sensory regression,Onset and duration of motor blockade and Total duration of analgesia will be recorded
|
| Intervention |
Spinal Anaesthesia |
Spinal anesthesia will be performed while placing the patients in the sitting position. Sterilization of patients’ back will be done with povidone iodine solution 10%. Lumbar puncture will be performed using a midline approach at the level of L2–L3 or L3–L4 using 25-G Quinckes spinal needle with the distal port facing laterally. Once free flow of cerebrospinal fluid was obtained, the study drug will be injected into the subarachnoid space.Total duration of intervention will be approx. 10 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA physical status Class I and Class
Patients without any severe comorbid diseases
|
|
| ExclusionCriteria |
| Details |
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 are excluded from the study
Pregnant females. chronic diseases such as diabetes and hypertension
Patients with body mass index >30 kg/m2
Patients shorter than 150 cm
|
|
|
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 |
Onset of sensory blockade
Maximum level of sensory blockade attained and the time taken for the same
Time for two-segment sensory regression
Onset and duration of motor blockade
Total duration of analgesia
|
1min, 2min, 3min, 4min, 5min, 6min, 7min, 8min, 9min, 10min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 270min, 300min, 330min, 360min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic changes, Adverse Effects |
5min, 10min, 15min, 20min, 25min, 30min, 35min, 40min, 45min, 50min, 55min, 60min |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
20/11/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal anesthesia is the most preferred technique for infraumbilical surgeries. Hyperbaric Ropivacaine has been shown to produce reliable and predictable anesthesia for surgery. Fentanyl, a synthetic lipophilic opioid, and Dexmedetomidine, a new highly selective alpha 2 agonist have been used as neuraxial adjuvants in spinal anesthesia to prolong intraoperative and postoperative analgesia. This study is undertaken to investigate and compare the clinical effects of 0.75% hyperbaric ropivacaine with additives such as fentanyl and dexmedetomidine on spinal anesthesia for infraumbilical surgeries. |