| CTRI Number |
CTRI/2024/03/063905 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
10/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Morphine and Dexmedetomidine with spinal anaesthesia drug bupivacaine on duration of pain free period. |
|
Scientific Title of Study
|
Comparison of Morphine Versus
Dexmedetomidine as Adjuvant to
Intrathecal Hyperbaric Bupivacaine on the
Duration of Anaesthesia in Infraumbilical
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 Santhosh M C B |
| Designation |
Associate Professor |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Mandya Institute of Medical Sciences, Mandya
Mandya 571401
Mandya
KARNATAKA
571401
India |
| Phone |
7892877646 |
| Fax |
|
| Email |
mcbsanthu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santhosh M C B |
| Designation |
Associate Professor |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Mandya Institute of Medical Sciences, Mandya
Mandya 571401
Mandya
KARNATAKA
571401
India |
| Phone |
7892877646 |
| Fax |
|
| Email |
mcbsanthu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santhosh M C B |
| Designation |
Associate Professor |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Mandya Institute of Medical Sciences, Mandya
Mandya 571401
Mandya
KARNATAKA
571401
India |
| Phone |
7892877646 |
| Fax |
|
| Email |
mcbsanthu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mandya Institute of medical sciences, Mandya 571401 |
|
|
Primary Sponsor
|
| Name |
Dr Santhosh M C B |
| Address |
Associate Professor, Department of Anaesthesiology, MIMS, Mandya 571401 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Varun N S |
Fisrt year PG student, Department of Anaesthesiology, MIMS, Mandya 571401 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Varun N S |
Mandya Institute of Medical Sciences |
Department of Anaesthesiology, Mandya Institute of Medical Sciences, Bangalore-Mysore Road, Mandya 571401
Mandya
KARNATAKA |
8431528820
varunns2104@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee, MIMS |
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 |
DEXMEDETOMIDINE |
15mg hyperbaric bupivacaine 0.5% with 2.5 mcg dexmedetomidine will be given intrathecally in patients undergoing infraumbilical surgeries. Patients will be observed for 12 hours post operatively. |
| Intervention |
MORPHINE |
15mg hyperbaric bupivacaine 0.5% with 150mcg morphine will be given intrathecally in patients undergoing infraumbilical surgeries. Patients will be observed for 12 hours post operatively.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists(ASA) Physical Status Grade
I and Grade II patients.
Patients within BMI range of 18.5kg
- 24.9
Patients willing to give informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patients on long term treatment with any opioids and α2 agonist
Patients taking α receptor antagonists, calcium channel blockers,
angiotensin converting enzyme inhibitors or on any kind of analgesics
Patients who are pregnant. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the sensory and motor characteristics between morphine
and dexmedetomidine as adjuvant to intrathecal 0.5% hyperbaric
bupivacaine in spinal anaesthesia for infraumbilical surgeries. |
12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare cardiorespiratory changes between the groups
To compare adverse events between the groups |
12 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/03/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In this study I will be administering 2.5 mcg dexmedetomidine with 0.5% hyperbaric bupivacaine 15mg to one group and 150 mcg morphine with 0.5% hyperbaric bupivacaine 15 mg to another group of patients who are undergoing infraumbilical surgeries and who are fulfilling our inclusion and exclusion criteria. The primary aim of this study is to compare duration of anaesthesia between two groups and time for first rescue analgesia. Adverse effects if any will be observed and treated accordingly. |