FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pathaksoumi@gmail.com].

  6. 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.

  7. 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

 
Close