| CTRI Number |
CTRI/2025/05/087427 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of intravenous Ketamine or Magnesium sulphate given during operation after induction for assessment of pain in surgical site in patients undergoing MRM Surgeries |
|
Scientific Title of Study
|
Effect of Intraoperative Ketamine versus Magnesium sulphate on Incidence of Chronic Postsurgical pain in Patients Undergoing 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 Arun Kumram |
| Designation |
PG Resident |
| Affiliation |
Pt JNM Medical College Raipur CG |
| Address |
Department of Anaesthesiology and Pain Medicine Pt JNM Medical College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9098848522 |
| Fax |
|
| Email |
dr.arunkumram0591@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratiksha Agrawal |
| Designation |
Associate Professor |
| Affiliation |
Pt JNM Medical College Raipur CG |
| Address |
Department of Anaesthesiology and Pain Medicine Pt JNM Medical College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
8815155558 |
| Fax |
|
| Email |
dr.pratiksha.agrawal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Kumram |
| Designation |
PG Resident |
| Affiliation |
Pt JNM Medical College Raipur CG |
| Address |
Department of Anaesthesiology and Pain Medicine Pt JNM Medical College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9098848522 |
| Fax |
|
| Email |
dr.arunkumram0591@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Pain Medicine Pt JNM Medical College , Opposit jail Road,Raipur, Chhattisgarh, India PIN CODE - 492001 |
|
|
Primary Sponsor
|
| Name |
Pt JNM Medical College Raipur CG |
| Address |
Department of Anaesthesiology and Pain Medicine, Pt. JNM Medical college, Opposit jail road,Raipur, Chhattisgarh , India Pin Code 492001
Type of Sponsor |
| 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 Arun Kumram |
Dr Bhim Rao Ambedkar Memorial Hospital Raipur Chhattisgarh |
Major OT, 2nd Floor
Department Of Anaesthesiology and Pain Medicine
Raipur CHHATTISGARH
Raipur
CHHATTISGARH |
9098848522
dr.arunkumram0591@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Pt JNM Medical College Raipur Chhattisgarh |
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 |
Ketamine |
Intraoperative Ketmine 0.25 mg Per kg intravenous infusion in 100ml NS over 10 minutes followed by iv infusion 0.15mg per kg per till extubation |
| Comparator Agent |
Magnesium sulphate |
Intraoperative Ketmine 50 mg Per kg intravenous infusion in 100ml NS over 10 minutes followed by iv infusion 08mg per kg per till extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Age: 18-65 years
Sex : Female
ASA physical status: I-II
Scheduled for elective modified radical mastectomy.
|
|
| ExclusionCriteria |
| Details |
Patient Refusal
Morbid Obesity
History of Psychological Problems
Pregnancy or Breastfeeding
Known case of Neuropathic disease
Patients on Chronic pain medications
Any known contraindication to drugs understudy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The incidence of chronic post surgical pain within 6 months.
Time to first rescue analgesia. |
The incidence of chronic post surgical pain within 6 months.
Time to first rescue analgesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The incidence of chronic post surgical pain within 6 months.
Time to first rescue analgesia..
Patients satisfaction score, (likert’s scale).
Effect of chronic pain on quality of life (EuroQol 5-dimension).
Incidence of postoperative complications such as PONV, hallucination & pruritis, urine output, decrease in respiratory rate.
|
Intraoperative monitoring at induction 0 15 30 45 90 105 120minutes
acute postoperative pain & monitoring VAS SCORE,HR, BP,SP02 AT 0 1 2 3 4 8 12 24minutes
Time to Rescue Analgesia in hours
EuroQol 5D Score 01 03 06month
DN 4 Questionnaire score 01 03 06month |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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 4 |
|
Date of First Enrollment (India)
|
10/06/2025 |
| 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 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
|
This study is randomised double blind and study the effect of intraoperative ketamine versus magnesium sulphates on post surgical pain on ongoing modified medical mastectomy which conducted in India the primary outcome will be the chronic post surgical pain at 6 month time to give first rescue analgesia and number of dose and likerts scale n effect of chronic pain on quality not life euroQol 5 d and sample size is 74
|