| CTRI Number |
CTRI/2022/07/043777 [Registered on: 06/07/2022] Trial Registered Prospectively |
| Last Modified On: |
01/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to see the requirement of of Pain injection dose in Breast Surgery |
|
Scientific Title of Study
|
A comparative study of intraoperative fentanyl requirement between surgical pleth index and haemodynamic guidance in mastectomies |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Tandu |
| Designation |
junior resident |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Dr.Priyanka,
Junior resident,
Dept of Anaesthesia,
Nizams Institute of Medical Sciences
Hyderabad
TELANGANA
500082
India |
| Phone |
7893849489 |
| Fax |
|
| Email |
draa42946@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Singam Geetha |
| Designation |
Associate Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Dr.S.Geetha,
Associate professor,
Dept of Anaesthesia,
Nizams Institute of Medical Sciences,
Panjagutta.
Hyderabad
TELANGANA
500082
India |
| Phone |
9441043075 |
| Fax |
|
| Email |
singamgeetha11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Singam Geetha |
| Designation |
Associate Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Dr.S.Geetha,
Associate professor,
Dept of Anaesthesia,
Nizams Institute of Medical Sciences,
Panjagutta.
Hyderabad
TELANGANA
500082
India |
| Phone |
9441043075 |
| Fax |
|
| Email |
singamgeetha11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Nizams Institute of Medical sciences |
| Address |
Nizams Institute of Medical Sciences
Panjagutta
Hyderabad
Pincod: 500082 |
| 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 |
| Singam Geetha |
Nizams institute of medical sciences |
OT3
specality block
Hyderabad
TELANGANA |
9441043075
singamgeetha11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nims Institutional Ethics Committee |
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 |
hemodynamic parametre guided fentanyl administration group |
patients will be administered intravenous fentanyl 1 microgram/kg during the procedure time or up to 3 hours whichever is of lesser duration according to the hemodynamic responses intraoperatively in mastectomy surgeries |
| Intervention |
surgical plath index(SPI) guided fentanyl administtration group |
mastectomy patients were intraoperatively administered fentanyl so as to maintain SPI within a range of 40-60 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. 18 – 65 years
2. ASA grade I and II
3. Females
4. Scheduled for elective mastectomy
|
|
| ExclusionCriteria |
| Details |
1. Patient Refusal
2. Known allergy to Fentanyl drug
3. Hypertension & those on beta blockers
4. Cardiovascular disease, Cardiac arrhythmias, drugs influencing HR, Pacemakers
5. Previous Sympathectomy, Vagotomy
6. Respiratory disorder like asthma
7. Neurologic disorders like Seizures
8. Renal disease
9. Patients on chronic medication like analgesics or psychiatric medication
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| intraoperative dose of fentanyl requirement |
baseline till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.postop rescue analgesic requirement
2. extubation time
3.degree of postop pain
|
baseline till postop rescue analgesic requirement |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
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
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [singamgeetha11@gmail.com].
- For how long will this data be available start date provided 09-12-2022 and end date provided 09-07-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
After obtaining institutional ethical commitee approval and CTRI acknowledgement number, and written informed consent from patients, A prospective randomised controlled study will be conducted in 30 ASA I-II female patients aged 18 to 65 years undergoing mastectomy under general anaesthesia and amount of fentanyl consumption will be compared between haemodynamic and SPI guidance. Patients refusing, allergic to fentanyl, hypertension, on beta blockers, cvs, CNS, renal and respiratory diseases will be excluded. Patients will be advised fasting 8 hours before surgery and administered rantac and alprozolam tablets. Later the patients will be shifted to OT, connected to monitors: NIBP, ECG, SPI, spo2, ETCO2 and IV fluid administered, Baseline VITALS: HR, RR, SPO2, SBP.DBP, MAP noted. Patients will be premedicated with iv fentanyl, glycopyrolate, induced and later intubated and connected to ventilator. Vitals will be noted every 5 minutes till end of surgery and fentanyl requirement will be recorded. Later at the end of surgery patient will be extubated. Degree of postop pain, dose of first rescue analgesic requirement , extubation and any adverse events will be noted. |