| CTRI Number |
CTRI/2026/01/102552 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Combnination Of Sedative And Analgesics For Various Surgeries. |
|
Scientific Title of Study
|
Dexmedetomidine, Ketamine and Propofol Infusions: An effective combination for Sedation and Analgesia: A Multicentric 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 |
Neha Kumar |
| Designation |
Associate Professor |
| Affiliation |
GSVM MEDICAL COLLEGE, KANPUR |
| Address |
Department Of Anaesthesia
GSVM Medical College
Swaroop Nagar
Kanpur
UP 208002
Department Of Anaesthesia
GSVM Medical College
Swaroop Nagar
Kanpur
UP 208002
Kanpur Nagar
UTTAR PRADESH
208005
India |
| Phone |
08874311115 |
| Fax |
|
| Email |
dr.nehamishra86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Kumar |
| Designation |
Associate Professor |
| Affiliation |
GSVM MEDICAL COLLEGE, KANPUR |
| Address |
Department Of Anaesthesia
GSVM Medical College
Swaroop Nagar
Kanpur
UP 208002
Department Of Anaesthesia
GSVM Medical College
Swaroop Nagar
Kanpur
UP 208002
Kanpur Nagar
UTTAR PRADESH
208005
India |
| Phone |
08874311115 |
| Fax |
|
| Email |
dr.nehamishra86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha Kumar |
| Designation |
Associate Professor |
| Affiliation |
GSVM MEDICAL COLLEGE, KANPUR |
| Address |
Department Of Anaesthesia
GSVM Medical College
Swaroop Nagar
Kanpur
UP 208002
Department Of Anaesthesia
GSVM Medical College
Swaroop Nagar
Kanpur
UP 208002
Kanpur Nagar
UTTAR PRADESH
208005
India |
| Phone |
08874311115 |
| Fax |
|
| Email |
dr.nehamishra86@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GSVM Medical college |
| Address |
117/H-2/184, PANDU NAGAR
Kanpur, Uttar Pradesh 208005 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Anil Kumar Verma |
GSVM Medical College, Kanpur |
Department Of Anaesthesia
GSVM Medical College
Swaroop Nagar
Kanpur
UP 208002
Kanpur Nagar
UTTAR PRADESH |
09336107410
anil_16021976@rediffmail.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSVM MEDICAL COLLEGE, KANPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K810||Acute cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine, Ketamine and Propofol |
all the drugs will be given in infusion
Dose: dexmedetomidine- 0.7 mic/kg/hour infusion till surgery is completed
ketamine- 0.3 mg/kg/hour infusion till surgery is completed
propofol- 100 mic/kg/minute infusion till surgery is completed |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
posted for various surgeries like parotidectomy, MRM |
|
| ExclusionCriteria |
| Details |
Surgeries which require more muscle relaxation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| degree of sedation and analgesia |
every 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| adverse effects |
every 10 minutes |
|
|
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 2 |
|
Date of First Enrollment (India)
|
14/02/2026 |
| 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="6"
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
|
we are giving infusions of propofol, dexmedetomedine and ketamine infusion to cover sedation and analgesia in various surgical procedures like paroditectomy, modified radical mastectomy wherein muscle relaxation is not needed in huge amount to see whether analgesia and sedation is adequate in such patients with out muscle relaxation |