| CTRI Number |
CTRI/2024/06/069024 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of intravenous Ketamine and Dexmedetomidine on pain following breast surgery. |
|
Scientific Title of Study
|
Comparative study of intraoperative intravenous Ketamine and Dexmedetomidine on post-operative analgesia after Modified Radical Mastectomy. |
| 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 Rajat Arora |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences,BHU |
| Address |
Department Of Anaesthesiology,
Institute of Medical Science Banaras Hindu University , Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8191922333 |
| Fax |
|
| Email |
arorarajat499@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S K Mathur |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences,BHU |
| Address |
Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University , Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450955143 |
| Fax |
|
| Email |
skmathurbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S K Mathur |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences,BHU |
| Address |
Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University , Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450955143 |
| Fax |
|
| Email |
skmathurbhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology, Institute Of Medical Sciences BHU, Varanasi , Uttar Pradesh, India
Pincode : 221005 |
|
|
Primary Sponsor
|
| Name |
Institute Of Medical Sciences |
| Address |
Institute of Medical Sciences
VARANASI,UP
221005 |
| 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 |
| Dr Rajat Arora |
Sir Sundarlal Hospital ,Institute Of Medical Sciences |
Department of Anaesthesiology Institute of Medical Sciences, Banaras Hindu University , Varanasi
221005
Varanasi
UTTAR PRADESH |
8191922333
arorarajat499@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , Institute Of Medical Sciences,BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Dexmedetomidine |
GROUP D – Will be given Intra venous Dexmedetomidine as a loading dose of 0.6microgm/kg over 10 minutes followed by maintenance infusion dose of 0.5microgm/kg/hr till 15 minutes before the surgery ends. |
| Comparator Agent |
Injection Ketamine |
GROUP K – Will be given as Intravenous Ketamine as loading dose of 0.5 mg/kg over 10 minutes followed by infusion of 0.3 mg/kg/hr till 15 minutes before the surgery ends.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients undergoing elective MRM
surgery under General Anaesthesia.
2. Age Group 18 years to 60 year.
3. ASA Grade 1 or 2 physical state.
|
|
| ExclusionCriteria |
| Details |
1.Planned post operative mechanical ventilation.
2.Planned regional anaesthesia/analgesia.
3.Perioperative Gabapentin, Magnesium use.
4.Pregnancy or breastfeeding.
5.Allergy to study medications.
6.H/O psychiatric disorder and substance abuse.
7.Significant preoperative hepatic dysfunction
8.Patient’s refusal. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post-op pain (by VAS score). |
1hour, 2hours, 3hours, 4hours, 6hours, 8hours, 12hours, 18hours and 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sedation (by Ramsay sedation scale), postoperative nausea and/or vomiting |
1hour, 2hours, 3hours, 4hours, 6hours, 8hours, 12hours, 18hours and 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/06/2024 |
| 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="0"
Months="7"
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
|
The study will be conducted
in Department of anesthesiology the IMS, BHU , Varanasi ,U.P,
India after Institute Ethics Committee (IEC) approval and written informed consent from parents/guardian of
patients. After CTRI registration 70 patients between 18 years to 60 years undergoing Modified Radical Mastectomy will be included according to inclusion and exclusion criteria. Patient will be randomly allocated into 2 groups according to
random allocation sequence generated online. GROUP K – Will be
given IV Ketamine as loading dose of 0.5 mg/kg over 10 minutes followed by
infusion of 0.3 mg/kg/hr.
GROUP D – Will be
given IV Dexmedetomidine as a loading dose of 0.6microgm/kg over 10 minutes
followed by maintenance infusion dose of 0.5microgm/kg/hr.
All
patients will receive General Anaesthesia as per institutional protocol with
Injection Midazolam 0.05mg/kg IV, Injection Fentanyl 2mcg/kg IV given before
induction. The anaesthesia will be induced by Injection Propofol 1.5-2 mg/kg
and tracheal intubation will be facilitated after Injection Vecuronium 0.1mg/kg
after pre oxygenated with 100% oxygen for 3 minutes. Endotracheal tube will be connected
to ventilator on the volume control mode with tidal volume of 6-8ml/kg and end
tidal CO2 maintained between 35-45. Anaesthesia will be maintained by
combination of Isoflurane, air, oxygen and intermittent Injection Vecuronium 0.01mg/kg.
Injection Paracetamol 15mg/kg IV and Injection Tramadol 1mg/kg IV will be given
to all cases in first hour of surgery and Injection Ondansetron 0.15 mg/kg IV
15 min prior to the reversal of neuromuscular blockade. 10 minutes before the completion of surgery,
study drugs will be stopped and residual neuromuscular blockade will be
reversed with Injection Neostigmine 0.05 mg/kg and Glycopyrrolate 0.01 mg/kg. The trachea will be extubated after fulfilling
extubation criteria and patient will be shifted to the post- anaesthetic care
unit (PACU) where post-op monitoring of pain (by VAS score), sedation (by
Ramsay sedation scale), postoperative nausea and/or vomiting, and complications
(like hallucination, pruritus) will be done till 24hours after surgery. The
Visual Analog Scale (VAS)will be monitored immediately in PACU and at 1hour,
2hours, 3hours, 4hours, 6hours, 8hours, 12hours, 18hours and 24 hours postoperatively. |