| CTRI Number |
CTRI/2026/04/107230 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study how anaesthetic agents (ketamine, combined with dexmedetomidine) can alter mood and thoughts and reduce the need for painkillers in patients undergoing Breast Surgery. |
|
Scientific Title of Study
|
To compare the analgesic efficacy and positive psychedelic
symptoms of different doses of ketamine in combination with
dexmedetomidine in patients undergoing opioid-sparing Breast
cancer Surgery (BCS) |
| 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. Soumi Pathak |
| Designation |
Consultant Anesthesia |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Center |
| Address |
RGCIRC, Department of Anesthesia sector 5, Rohini, Delhi 110085, India RGCIRC, Department of Anaesthesia, Sector 5, Rohini, Delhi 110085, India North West DELHI 110085 India |
| Phone |
09891620042 |
| Fax |
|
| Email |
pathaksoumi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Soumi Pathak |
| Designation |
Consultant Anesthesia |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Center |
| Address |
RGCIRC Depatment of Anesthesia,sector 5, Rohini, Delhi 110085, India RGCIRC Department of Anesthesia sector 5, Rohini, Delhi 110085, India North West DELHI 110085 India |
| Phone |
09891620042 |
| Fax |
|
| Email |
pathaksoumi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr.Soumi Pathak |
| Designation |
Consultant Anesthesia |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Center |
| Address |
RGCIRC Department of Anesthesia , Sector 5, Rohini, Delhi 110085, India RGCIRC Department of Anesthesia sector 5, Rohini, Delhi North West DELHI 110085 India |
| Phone |
09891620042 |
| Fax |
|
| Email |
pathaksoumi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Cancer Institute and Research Center |
| Address |
RGCIRC Department of Anaesthesia Sector 5, Rohini, Delhi, India 110085 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Soumi Pathak |
Rajiv Gandhi Cancer Institute and Reseach Center |
RGCIRC,Department of Anesthesia Sector 5, Rohini, Delhi 110085, India North West DELHI |
09891620042
pathaksoumi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RGCIRC/IRB |
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 |
Ketamine infusion group |
Ketamine infusion will be started at 0.25mg kg-1, 0.5mg kg-1 and 1mgkg-1 after standard induction according to the groups allotted. Infusion will be stopped at the end of surgery. After extubation, patients will be assessed using the modified Alderete score, VAS, CADSS, BPRS, LIKERT SCALE and Ramsay sedation score |
| Comparator Agent |
Saline placebo infusion |
Saline infusion will be started after standard anaesthesia induction till the end of surgery. After extubation on the table and an hour postoperatively, patients will be assessed using VAS, CADSS, BPRS and Likert score |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA1,2
BMI 18–35 kg/m2 |
|
| ExclusionCriteria |
| Details |
• H/o epilepsy
• Raised ICT
1. Pre-op antipsychotic medication history
2. Uncontrolled hypertension
3. Allergy
4. AV block patients, cardiac ailments, low EF
5. Glaucoma, previous ocular surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| postoperative pain intensity measured by VAS score, intraoperative opioid requirement, incidence and severity of positive psychedelic symptoms. |
1.T1 baseline assessment of CADSS
2. T2 Postoperative pain intensity measured by VAS score, intraoperative opioid requirement, severity of positive psychedelic symptoms.
T3- VAS score and severity of positive psychedelic symptom 2hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the recovery profile using the modified Aldrete score ,Sedation score using Ramsay sedation scale
Haemodynamic variability between the groups
Postoperative patient’s satisfaction using Likert’s scale
To record presence of nystagmus, diplopia or headache and PONV
|
At extubation and one hour postoperative |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/04/2026 |
| 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="1" Months="0" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pathaksoumi@gmail.com].
- For how long will this data be available start date provided 10-11-2027 and end date provided 10-02-2031?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Breast cancer surgery is commonly associated with significant perioperative pain and opioids have been the cornerstone of analgesia. however, adverse effects associated with opioids has encouraged the development of opioid sparing anaesthesia. ketamine is a potent analgesic and is associated with dose dependent psychedlic side effects such as hallucinations, agitation and altered perception which limits its use in perioperative analgesia. dexmedetomidine has been shown to attenuate ketamine induced sympathetic stimulation and reduce psychotomimetic effects making the combination of these helpful in opioid sparing.
Primary Objective :
To assess and compare the analgesic efficay with
concurrent positive affective symptoms, between three doses of ketamine
infusion in combination with dexmedetomidine infusion, at extubation and 30
minutes into post-operative period.
Secondary Objective :
To compare the recovery profile using the modified
Aldrete score between the three groups at extubation and 30 minutes into the post-operative
period.
Sedation score using Ramsay sedation scale
Haemodynamic variability between the groups
Postoperative patient’s satisfaction using Likert’s
scale
To record presence of nystagmus, diplopia or headache
and PONV Inclusion criteria : ·
Breast conservation oncosurgery
patients in age group 18 – 60 years ·
ASA gd 1 - 3 Exclusion criteria : ·
H/o epilepsy ·
Raised ICT, prev. cranial surgery or
trauma ·
Pre-op psychosis, schizophrenia ·
Pre-op antipsychotic medication
history ·
Active substance abuse ·
Uncontrolled hypertension ·
Allergy ·
Av block patients, cardiac ailments,
low EF ·
Significant coronary artery disease ·
Glaucoma / prev. occular surgery ·
Severe liver dysfunction Anesthesia
technique : Standard
anesthesia induction with Sevoflourane in O2:Air mixture + Fentanyl
@ 1mcg/kg + Propofol @ 1.5 mg/kg + Vecuronium 0.1 mg/kg will be done followed
by oral endotracheal intubation with 7.0 mm internal diameter. All patients
will be monitored using standard anesthesia monitoring, additionally applying
BIS monitoring in all patients. Anesthesia
will be maintained with Sevoflourane in O2: Air mixture, with Dexmedetomidine
4 mcg/ml infusion @ 0.5 mcg/kg/hr and Vecuronium 0.5 mg/ml infusion adjusted to
maintain Train of Four count of 1. A 2 mg/ml Ketamine infusion dose shall be instituted
as per the study group assigned randomly. Intermittent boluses of fentanyl shall be
given if either the heart or the blood pressure or both rise 20% above the
baseline, as physiological indicators of algesia. All patients will receive pre-emptive
analgesia with 1 gm i/v Paracetamol and 75mg Diclofenac in 100 ml normal saline
infused at the end of surgery. All patients will be reversed and extubated with
Sugammadex 2 mg/kg. The peri-operative questionnaires and parameters shall be recorded and monitored as
per the decided protocol. Observation : CADSS Score (preop & 2-hr post op)
BPRS score |