| CTRI Number |
CTRI/2022/05/042695 [Registered on: 20/05/2022] Trial Registered Prospectively |
| Last Modified On: |
19/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to compare the effect of dexmedetomidine versus ketamine in fracture femur patients |
|
Scientific Title of Study
|
Comparison of the effect of intravenous bolus and infusion of dexmedetomidine versus ketamine given intraoperative on postoperative analgesia in fracture femur patients operated under subarachnoid block - A prospective randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RANA ATHER |
| Designation |
Resident |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology Nizams Institute of Medical Sciences Punjagutta
Hyderabad
TELANGANA
500082
India |
| Phone |
08297710738 |
| Fax |
|
| Email |
ranaather9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SAPNA ANNAJI NIKHAR |
| Designation |
Professor |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology Nizams Institute of Medical Sciences Punjagutta
Hyderabad
TELANGANA
500082
India |
| Phone |
08297710738 |
| Fax |
|
| Email |
sapnanikhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RANA ATHER |
| Designation |
Resident |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology Nizams Institute of Medical Sciences Punjagutta
Hyderabad
TELANGANA
500082
India |
| Phone |
08297710738 |
| Fax |
|
| Email |
ranaather9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of Medical Sciences, Punjagutta, Hyderabad 500082, Telangana |
|
|
Primary Sponsor
|
| Name |
Nizams Institute of medical sciences Hyderabad India |
| Address |
Department of Anesthesiology, Nizams Institute of Medical Sciences Hyderabad |
| Type of Sponsor |
Research institution |
|
|
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 RANA ATHER |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
Department of Anesthesiology
Nizams Institute of Medical Sciences Punjagutta
Hyderabad
TELANGANA |
8297710738
ranaather9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
| Intervention |
Dexmedetomidine |
1 mcg/kg bolus followed by infusion of 0.5mcg/kg/hour till the end of surgery |
| Comparator Agent |
Ketamine |
0.3mg/kg bolus followed by infusion of 0.15mg/kg/hour till the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients of either sex
2)Patients with ASA grade 1 and grade 2
3)Patients aged between 18 to 65 years
4)Patients with femur fractures |
|
| ExclusionCriteria |
| Details |
1)Refusal to participate in the study
2)Peripheral neuropathy
3)Patients having coagulation or bleeding abnormalities
4)Local site infection
5)Altered mental status
6)Patients with significant coexisting diseases like ischemic heart disease, impaired renal function and severe liver disease
7)Patients on beta blockers
8)Patients allergic to bupivacaine, dexmedetomidine, ketamine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare postoperative analgesia and duration of analgesia after fracture
femur surgery in dexmedetomidine versus ketamine group |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| cumulative analgesic requirements, hemodynamic effects, side effects |
1 year |
|
|
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 3 |
|
Date of First Enrollment (India)
|
24/05/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective randomized controlled trial comparing the effect of dexmedetomidine versus ketamine given intraoperative o postoperative analgesia in fracture femur patients operated under subarachnoid block. Total 75 patients will be recruited with 25 in each group (group dexmedetomidine, group ketamine, control group). The primary outcome is to compare postoperative analgesia and duration of analgesia after fracture femur surgery in dexmedetomidine versus ketamine group and the secondary outcome is to assess cumulative rescue analgesic requirement in different groups, to compare hemodynamic effects, side effects |