| CTRI Number |
CTRI/2024/10/075685 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| 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
|
To compare two drug combinations in spinal anaesthesia in lower abdominal surgeries to compare the duration, efficacy of the drug combination. |
|
Scientific Title of Study
|
A Comparison of Intrathecal Fentanyl and Clonidine as an adjuvant to hyperbaric Ropivacaine during subarachnoid block for lower abdominal surgeries. A Prospective Randomized 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 Kamodula Hema |
| Designation |
Junior Resident |
| Affiliation |
KLE Dr Prabhakar Kore Hospital and MRC |
| Address |
Department of Anaesthesiology,2nd floor Jawaharlal Nehru Medical College,KLE Dr Prabhakar Kore Hospital, Belagavi.
KLE Dr Prabhakar Kore Hospital, Belagavi,Karnataka, 590010.
Belgaum
KARNATAKA
590010
India |
| Phone |
7207209736 |
| Fax |
|
| Email |
kamodulahema@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kedareshvara KS |
| Designation |
Professor |
| Affiliation |
KLE Dr Prabhakar Kore Hospital and MRC |
| Address |
Department of Anaesthesiology,2nd floor,Jawaharlal Nehru Medical College, Belagavi.
KLE Dr Prabhakar Kore Hospital,Belagavi, Karnataka,590010.
Belgaum
KARNATAKA
590010
India |
| Phone |
9964453463 |
| Fax |
|
| Email |
kedareshvara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kedareshvara KS |
| Designation |
Professor |
| Affiliation |
KLE Dr Prabhakar Kore Hospital and MRC |
| Address |
Department of Anaesthesiology,Jawaharlal Nehru Medical College,2nd floor, Belagavi.
KLE Dr Prabhakar Kore Hospital and MRC, Belagavi, Karnataka, 590010.
Belgaum
KARNATAKA
590010
India |
| Phone |
9964453463 |
| Fax |
|
| Email |
kedareshvara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Jawaharlal Nehru Medical College, Belagavi, karnataka, 590010. |
|
|
Primary Sponsor
|
| Name |
Dr Hema Kamodula |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Belagavi. |
| 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 Hema Kamodula |
KLE Prabhakar Kore Hospital and MRC |
Department of Anaesthesiology,second floor, Jawaharlal Nehru Medical College, Belagavi.
Belgaum
KARNATAKA |
7207209736
kamodulahema@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clonidine Group. |
Patients are administered with intrathecal 2.5ml of
Hyperbaric 0.75%Ropivacaine + 30mcg Clonidine before the infraumbilical surgeries lasting for under 3hours. |
| Intervention |
Fentanyl group. |
Patients are administered with intrathecal 2.5ml of Hyperbaric 0.75%
Ropivacaine + 25 mcg Fentanyl before the infraumbilical surgeries lasting for under 3 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA physical status I and II
2)Height ranging from 160 to 170cms
3)Patients undergoing elective infraumbilical surgeries |
|
| ExclusionCriteria |
| Details |
1)Patient refusal
2)Patients with coagulation abnormalities
3) Patients with neurological deficits
4)Patients with significant spine deformities
5)Allergies to the study medications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the onset and duration of sensory and
motor block,quality of block, post operative analgesia among two groups. |
0 min
1 min
2 min
3 min
4 min
5 min
Post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare effects on sedation and haemodynamics
among the two groups. |
0 min
5 min
10 min
15 min
20 min
25 min
30 min
45 min
60 min
75 min
90 min |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
15/11/2024 |
| 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
|
Various adjuvants have been used with local anaesthetics for prolongation ofintraoperative and post operative analgesia. This study is being undertaken to evaluate and compare theeffects of Fentanyl and Clonidine as intrathecal adjuvants to hyperbaric Ropivacaine inpatients undergoing lower abdominal surgeries. |