| CTRI Number |
CTRI/2025/11/096858 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Total intraoperative fentanyl consumption comparison in modified radical mastectomy patients under general anaesthesia |
|
Scientific Title of Study
|
Comparison of surgical pleth index guided analgesia with conventional analgesia technique for total intraoperative fentanyl consumption in patients undergoing modified radical mastectomy under general anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riya Choudhary |
| Designation |
PG Resident |
| Affiliation |
ABVIMS and Dr. RML Hospital |
| Address |
Room no. 301 3rd floor Depatment of Anaesthesia ABVIMS and Dr. RML HOSPITAL
Central
DELHI
110001
India |
| Phone |
9929482426 |
| Fax |
|
| Email |
Riyachoudhary260698@gmai.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akhilesh gupta |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Room no. 301 3rd floor Depatment of Anaesthesia ABVIMS and Dr. RML HOSPITAL
Central
DELHI
110001
India |
| Phone |
9810685426 |
| Fax |
|
| Email |
Drakhileshgupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akhilesh gupta |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Room no. 301 3rd floor Depatment of Anaesthesia ABVIMS and Dr. RML HOSPITAL
Central
DELHI
110001
India |
| Phone |
9810685426 |
| Fax |
|
| Email |
Drakhileshgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr. RML Hospital,Baba Kharak Singh Marg,Near Gurudwara Bangla sahib,Connaught place,New Delhi,Delhi 110001 central Delhi |
|
|
Primary Sponsor
|
| Name |
ABVIMS and dr Ram Manohar Lohia hospital |
| Address |
Baba Kharar Singh marg,near gurudwara bangla sahib,Connaught place,,central Delhi,new delhi 110001 |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrRiya Choudhary |
ABVIMS and Dr RML Hospital,New Delhi |
Room no. 301 3rd floor Depatment of Anaesthesia ABVIMS and Dr. RML HOSPITAL,Central Delhi 110001
Central
DELHI |
9929482426
Riyachoudhary260698@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee ABVIMS and Dr. RML Hospital,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional analgesia |
Conventional analgesia will be given and intraoperative fentanyl Consumption will be noted |
| Intervention |
Surgical pleth index guided analgesia |
Surgical pleth index guided analgesia will be given and intraoperative fentanyl consumption will be noted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA physical status 1 or 2
BMI between 18.5 and 30 kg/m2 |
|
| ExclusionCriteria |
| Details |
Allergy or hypersensitivity to fentanyl or study drugs
Chronic opioid use or analgesic dependence
Cardiovascular instability
Autonomic dysfunction or peripheral vascular disease
Severe hepatic or renal impairment
Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total intraoperative fentanyl consumption in microgram will be measured in surgical pleth index guided analgesia technique and conventional analgesia technique |
Baseline HR and SBP will be noted then intraoperative HR,SBP and fentanyl total doses will be noted |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Postoperative pain score in the form of numerical rating score(NRS) in recovery
2.Incidence of post operative nausea vomiting in recovery |
After the surgery is over that is post operative |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
11/11/2025 |
| 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="1"
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 prospective randomised parallel group interventional trial will include female patients aged 18-65 years
Two groups will be formed
Group 1 SPI Guided-fentanyl 0.5 microgram/kg admistered whenever SPI greater than 50
Group 2 Conventional- Fentanyl 0.5 micrograms/kg given hourly after induction and additionally if HR or SBP rise greater than 20 percent from baseline
All patients will undergo standardised anaesthesia induction with midazolam fentanyl propofol and vecuronium and maintenance with sevoflurane titrated to maintain entropy between 40-60
The primary outcome will be total intraoperative fentanyl consumption. |