| CTRI Number |
CTRI/2026/03/105407 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A research to compare the intraoperative hemodynamics between dexmedetomidine with ketamine and dexmedetomidine with fentanyl when given in general anaesthesia |
|
Scientific Title of Study
|
Usefulness of Ketamine versus Fentanyl as adjuvants with Dexmedetomidine infusion on perioperative hemodynamics and recovery profile |
| 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 Kavya S |
| Designation |
Postgraduate student |
| Affiliation |
Institute of Anaesthesiology Government Rajaji Hospital and Madurai Medical College |
| Address |
No.121 Institute of Anaesthesiology Anaesthesia division Government Rajaji Hospital and Madurai Medical college Madurai Tamil nadu
Madurai
TAMIL NADU
625020
India |
| Phone |
9113562879 |
| Fax |
|
| Email |
drkavyashankar3099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratheeba Durairaj MD DA |
| Designation |
Professor Institute of Anaesthesiology Madurai Medical College |
| Affiliation |
Institute of Anaesthesiology Government Rajaji Hospital and Madurai Medical College |
| Address |
No.121 Institute of Anaesthesiology Anaesthesia division Government Rajaji Hospital and Madurai Medical college Madurai Tamil nadu
Madurai
TAMIL NADU
625020
India |
| Phone |
9443183984 |
| Fax |
|
| Email |
rajdeep181069@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavya S |
| Designation |
Postgraduate student |
| Affiliation |
Institute of Anaesthesiology Government Rajaji Hospital and Madurai Medical College |
| Address |
No.121 Institute of Anaesthesiology Anaesthesia division Government Rajaji Hospital and Madurai Medical college Madurai Tamil nadu
Madurai
TAMIL NADU
625020
India |
| Phone |
9113562879 |
| Fax |
|
| Email |
drkavyashankar3099@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Anaesthesiology Government Rajaji Hospital and Madurai Medical College |
| Address |
No.121 Institute of anaesthesiology Anaesthesia division Government Rajaji Hospital and Madurai medical college Madurai 625020 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Kavya S |
Government Rajaji Hospital and Madurai Medical College |
Jica OT complex,5th floor Major general surgery ot 2&3 Government Rajaji Hospital Madurai
Madurai
TAMIL NADU |
9113562879
drkavyashankar3099@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 |
Inj Dexmedetomidine |
Highly selective alpha 2 adrenergic receptor which has smooth and hemodynamically stable intraoperative course because of analgesic and anaesthetic sparing effect and cardiovascular stabilising effects without respiratory depressio |
| Intervention |
Inj.Fentanyl |
My opioid receptor agonist inhibits ardently cyclase has cardio respiratory depressant effect |
| Intervention |
Ketamine |
NMDA Receptor antagonist causes dissociative anaesthesia synergistic effect with dexmedetomidine |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 AND 2
18-60 yrs age
Undergoing major abdominal surgery |
|
| ExclusionCriteria |
| Details |
ASA 3 nd 4
Heart block and arrhythmias
Basal heart rate less than 60
Patients on anti hypertensives
Known allergy to study drug
Known chronic use of analgesics and sedatives
Renal and hepatic dysfunction
Psychiatric disorders
Respiratory disorders and sleep apnea |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare hemodynamic parameters and recovery parameters when using intraoperative Dexmedetomidine infusion with Ketamine versus Fentanyl as an adjuvant |
Intraoperative and 6 hrs postoperative
1st postoperative day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare anaesthetic sparing effect
the need for post operative rescue analgesia
adverse effects in post operative periods |
Intraoperative & 6 hrs postoperative
1st postoperative day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/03/2027 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Perioperative use of dexmedetomidine as an adjunct to general anaesthesia has smooth and haemodynamically stable intraoperative and post-operative course and analgesic and anaesthetic sparing effect and cardiovascular stabilising effects without respiratory depression Slow onset of action of dexmedetomidine is the major limitation of its use Fentanyl with dexmedetomidine has explicated a better clinical outcome compared to dexmedetomidine But the cardiorespiratory depressant effect of opioids can aggravate the well-known side effects of dexmedetomidine like bradycardia and hypotension Ketamine an NMDA receptor antagonist causes tachycardia hypertension salivation nausea and emergence delirium but has a faster onset of action Thus the antagonising adverse effect profile of the two drugs can have a synergistic combination allowing smoother anaesthesia and recovery profile The use of ketamine allows faster onset of action thereby eliminating the slower onset seen with dexmedetomidine alone Also it has been studied with several adjuvants for effect potentiation This study aims to compare the clinical effects and recovery characteristics of intraoperative dexmedetomidine with ketamine versus dexmedetomidine with fentanyl infusion Comparison of outcomes will be based on
1 Intraoperative hemodynamics 2 Postoperative analgesia 3 Adverse effects
|