| CTRI Number |
CTRI/2021/07/035201 [Registered on: 28/07/2021] Trial Registered Prospectively |
| Last Modified On: |
27/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of two different doses of drug for sedation in patients undergoing operation under spinal anaesthesia |
|
Scientific Title of Study
|
Comparative Evaluation of Two Different Doses of Intravenous Dexmedetomidine Infusion for Sedating Patients Undergoing Lower Abdominal General Surgical Procedures under Spinal Anaesthesia
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Renuka R |
| Designation |
Associate professor |
| Affiliation |
Sapthagiri institute of medical sciences and research center |
| Address |
Sapthagiri institute of medical sciences and research center, Ground floor , ot complex Anaesthesia department
Sapthagiri institute of medical sciences and research center , Ground floor , ot complex Anaesthesia department
Bangalore
KARNATAKA
560090
India |
| Phone |
8618633196 |
| Fax |
08028393404 |
| Email |
drmadhumitha99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amulya P |
| Designation |
Post graduate student |
| Affiliation |
Sapthagiri institute of medical sciences and research center |
| Address |
Sapthagiri institute of medical sciences and research center, Ground floor , ot complex Anaesthesia department
Sapthagiri institute of medical sciences and research center , Ground floor , ot complex Anaesthesia department
Bangalore
KARNATAKA
560090
India |
| Phone |
7411074111 |
| Fax |
08028393404 |
| Email |
amulyapreyakumar74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amulya P |
| Designation |
Anaesthesia post graduate student |
| Affiliation |
Sapthagiri institute of medical sciences and research center |
| Address |
Sapthagiri institute of medical sciences and research center, Ground floor, ot complex Anaesthesia department
Sapthagiri institute of medical sciences and research center, Ground floor, ot complex Anaesthesia department
Bangalore
KARNATAKA
560090
India |
| Phone |
7411074111 |
| Fax |
08028393404 |
| Email |
amulyapreyakumar74@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sapthagiri institute of medical sciences and research center |
| Address |
15,Hesarghatta Main Rd, Navy Layout, Chikkasandra, Chikkabanavara, Bengaluru, Karnataka 560090 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Renuka R |
Sapthagiri institute of medical sciences and research center |
Ground floor , operation theatre complex , ANAESTHESIA department
Bangalore
KARNATAKA |
8618633196
08022188700
amulyapreyakumar74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri institute of meical sciences research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Maintenance doses of intravenous dexmedetomidine Group A - 0.2 microgram/kg/hour
Group B - 0.4 microgram/kg/hour |
Doses of dexmedetomidine -Group A - 0.2 microgram/kg/hour
Group B - 0.4 microgram/kg/hour
Route of administration - intravenous infusion.
Duration - Immediately after giving subarachnoid block the maintainence dose of Dexmedetomidine will be started and continued until the surgeon will begin to suture the surgical site (through out the intraoperative period) for patients undergoing lower abdominal surgeries under subarachnoid block. |
| Comparator Agent |
Normal saline infusion |
In placebo group normal saline infusion group will be done through out the surgey. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)American society of anaesthesiology (ASA) physical status 1 and 2 patients.
|
|
| ExclusionCriteria |
| Details |
1)Patients undergoing laparoscopic surgeries.
2)Patients who have arrhythmia , heart failure , liver failure , renal failure or bleeding tendencies.
3)Patients with heart blocks , on calcium channel blockers and betablockers.
4)Allergic to study drug and local anesthetic.
5)Those who are not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of intravenous Dexmedetomidine infusion on sedation and duration of analgesia. |
For intraoperative period and for 24 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate hemodynamic changes and side effects of study drug if any. |
For intraoperative period and for 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 2 |
|
Date of First Enrollment (India)
|
31/07/2021 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet submitted |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [amulyapreyakumar74@gmail.com].
- For how long will this data be available start date provided 23-07-2021 and end date provided 23-07-2024?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Subarachnoid
block is a widely used regional anaesthetic technique particularly
advantageous for lower abdominal surgeries (l).Many spinal and epidural anaesthetic
failed because of inadequate intravenous sedation and anxiolysis rather
than technically flawed blocks .As unsedated patient may be apprehensive and
uncooperative to the surgical procedure inspite of having adequate levels of
analgesia by spinal anesthesia . Patients are often reluctant to remain awake during a procedure and the requirement to maintain uncomfortable
positioning throughout the surgery of
long duration can cause spontaneous movements which may interfere with the
surgical procedure. Therefore, provision
of adequate sedation is important if the advantages of spinal anaesthesia
to be fully appreciated.The
literature review has few studies to asess
the efficacy of intravenous ( IV )
dexmedetomidine infusion on spinal
anesthesia block characteristics however ,
there are no studies till date to asess
its efficacy on sedation or to evaluate the ideal dose of IV dexmedetomine
infusion for sedation .Hence
this study has been formulated to
compare two different doses of dexmedetomidine infusion to provide continuous sedation in patients undergoing
lower abdominal general surgical procedures under spinal anesthesia |