| CTRI Number |
CTRI/2024/02/062910 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare post operative pain relief using drugs dexmedetomidine and fentanyl added to bupivacaine in lower abdominal surgery. |
|
Scientific Title of Study
|
A comparative study of post operative analgesia using intra thecal Dexmedetomidine and fentanyl as adjuvant to bupivacaine in lower abdominal surgeries. A Randomized double blinded 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 |
Konjengbam Reshmi Devi |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal
Imphal West
MANIPUR
795004
India
Imphal West
MANIPUR
795004
India |
| Phone |
9774207394 |
| Fax |
|
| Email |
reshmi.konjngbam7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kh Maniram Singh |
| Designation |
Professor,Department of Anaesthesiology |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences Imphal Imphal West MANIPUR 795004 India
Imphal West
MANIPUR
795004
India |
| Phone |
8259055986 |
| Fax |
|
| Email |
drmram6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yumnam Arunkumar Singh |
| Designation |
Assistant Professor,Department of Anaesthesiology |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences Imphal Imphal West MANIPUR 795004 India
Imphal West
MANIPUR
795004
India |
| Phone |
9862282518 |
| Fax |
|
| Email |
yaks48@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur |
|
|
Primary Sponsor
|
| Name |
Konjengbam Reshmi Devi |
| Address |
Regional Institute of Medical Sciences, Imphal, Manipur |
| 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 |
| DrKonjengbam Reshmi Devi |
Regional Institute of Medical Sciences,Imphal |
Elective surgery Operation theatre complex (OT 1-8), Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur Imphal West MANIPUR
Imphal West
MANIPUR |
9774207394
reshmi.konjngbam7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, Regional institute of Medical Sciences, Imphal, Manipur |
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 |
Hyperbaric bupivacaine with dexmedetomidine. |
Group B- will receive 2 ml 0.5% hyperbaric bupivacaine + 0.5 ml of (5 mcg) dexmedetomidine intraoperatively before skin incision through spinal anaesthesia under strict aseptic precaution and effect of analgesia observed postoperatively |
| Intervention |
Hyperbaric bupivacaine with Fentanyl citrate. |
Group A will receive 2 ml 0.5% hyperbaric bupivacaine + 0.2 ml (12.5μgm) Fentanyl citrate intraoperatively before skin incision through spinal anaesthesia under strict aseptic precaution and effect of analgesia observed postoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anaesthesiologists (ASA) physical status I and II.
2. 18- 65 years of age.
3. Either sex |
|
| ExclusionCriteria |
| Details |
1. History of allergy to study drugs
2. Bleeding disorder
3. Local site infection
4. Cardiac,respiratory and kidney disorder,neurological deficit
5.Spinal deformity |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of postoperative Analgesia (demand of first rescue analgesia)in first 24 hours |
Outcome will be assessed at 24 hours post-op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hemodynamic parameters- Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), oxygen saturation (spo2)
2. Adverse effects. |
Outcome will be assessed at baseline
2min intra-op
4min intra-op
6min intra-op
8min intra-op
10min intra-op
then every 5 min after 10 min intraoperatively & for 24 hour period post op to see any adverse effect |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
02/03/2024 |
| 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
|
The study will be a prospective randomized double-blinded study to assess and compare the effects of intrathecal administration of low dose of 10mg hyperbaric Bupivacaine with 5 mcg dexmedetomidine and 10 mg hyperbaric Bupivacaine with 12.5 mcg fentanyl. A total of 60 patients will be selected for the study and divided into 2 groups of 30 patients each Group A (n-30) and Group B (n-30). According to a computer-generated randomization table, patients in group A will be administered 2 ml of 0.5% bupivacaine heavy and 0.5ml (12.5µgm) fentanyl citrate and group B will be administered 2 ml of 0.5% bupivacaine heavy and 0.1 ml of 5 mcg dexmedetomidine in the subarachnoid space L3-L4. In both the groups, the study drugs will be administered at a rate of 0.2 ml/min. in the subarachnoid space L3-L4. The block characteristics along with regression of the blockade, side effects (if any) and the hemodynamic changes will be observed, assessed and recorded by blinded investigator using the VAS and sedation scale. The finding and observation made during the entire study will be tabulated graphically depicted whenever possible, statistically analysed and inference will be drawn to evaluate the duration of post-operative analgesia and side effects of the two study drugs. |