| CTRI Number |
CTRI/2020/06/025694 [Registered on: 08/06/2020] Trial Registered Prospectively |
| Last Modified On: |
29/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of 3 opioid drugs on blood pressure,heart rate,respiratory rate etc during surgery and to see its effectiveness in controlling pain during and 6 hours after surgery |
|
Scientific Title of Study
|
A comparative study of intravenous Fentanyl, Nalbuphine and Butorphanol on hemodynamic stress response to intubation and post-operative analgesia in modified radical mastectomy- A prospective randomized control study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Beas Mukherjee |
| Designation |
Post Graduate trainee,Anaesthesiology |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Department of Anaesthesiology and Pain Relief,
Kidwai Memorial Institute of Oncology,Hombegowda Nagar
Bangalore
KARNATAKA
560029
India |
| Phone |
08811802902 |
| Fax |
|
| Email |
alipore62@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashidhar GS |
| Designation |
Associate Professor |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Department of Anaesthesiology and Pain Relief,Kidwai Memorial institute of Oncology,Hombegowda nagar,Bengaluru
Byrasandra, Jayanagar
Bangalore
KARNATAKA
560029
India |
| Phone |
9008028611 |
| Fax |
|
| Email |
drshashi_2007@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Beas Mukherjee |
| Designation |
Post Graduate trainee,Anaesthesiology |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Department of Anaesthesiology and pain relief
Kidwai Memorial institute of Oncology
Hombegowda Nagar
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
08811802902 |
| Fax |
|
| Email |
alipore62@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Pain Relief
kidwai Memorial institute of Oncology
Hombegowda Nagar
Bengaluru |
| Kidwai Memorial institute of Oncology,Bengaluru |
|
|
Primary Sponsor
|
| Name |
Beas Mukherjee |
| Address |
Post Graduate trainee
Department of Anaesthesiology and Pain Releif
Kidwai Memorial Institute Of Oncology
Hombegowda Nagar
Bengaluru |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Beas Mukherjee |
Room No. 105 ,Department of Anaesthesiology and pain reliefKidwai Memorial Institute of Oncology |
Room Number 105
Department of Oncology
Kidwai Memorial Institute of Oncology,Bengaluru
Bangalore
KARNATAKA |
08811802902
alipore62@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Clinical study,Kidwai Institute of Oncology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IV Butorphanol |
IV Butorphanol 20 micrograms/kg 5 minutes prior to induction of case,single dose. Introperative rise of SBP,DBP,MAP managed by intravenous NTG at the rate of 2-5 micrograms/kg/min in titrated dose.Post operative 6 hours pain is assessed by VAS score,if VAS4 then rescue analgesia with Fentanyl 0.5 micrograms/kg to be given,no other analgesia. |
| Comparator Agent |
IV Fentanyl |
IV Fentanyl 20 micrograms/kg,single dose. Introperative rise of SBP,DBP,MAP managed by intravenous NTG at the rate of 2-5 micrograms/kg/min in titrated dose.Post operative 6 hours pain is assessed by VAS score,if VAS4 then rescue analgesia with Fentanyl 0.5 micrograms/kg to be given,no other analgesia. |
| Intervention |
IV Nalbuphine |
IV Nalbuphine 0.2 mg/kg 5 minutes prior to induction of the case,single dose. Introperative rise of SBP,DBP,MAP managed by intravenous NTG at the rate of 2-5 micrograms/kg/min in titrated dose.Post operative 6 hours pain is assessed by VAS score,if VAS4 then rescue analgesia with Fentanyl 0.5 micrograms/kg to be given,no other analgesia. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Female patients with breast carcinoma posted for modified radical mastectomy aged between 18-65 years ,giving valid informed consent belonging to ASA I and II. |
|
| ExclusionCriteria |
| Details |
Patient refusal or patients in ASA III or IV grade or having history of allergy to opioid group of drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Haemodynamic response to intubation-Heart rate,Systolic Blood pressure,diastolic blood pressure,mean arterial pressure,SPO2.
post operative analgesia for 6 hours after completion of surgery.
Visual analogue scale |
Baseline,5 mins after drug,1 min after Intubation,3 mins after intubation,5 mins after intubation followed by every 30 minutes during surgery.postoperatively -after extubation,5 mins after extubation followed by every 30 minutes for next 6hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative Analgesia-visual Analogue scale(VAS) for pain assessment,systolic blood pressure,diastolic blood pressure,mean blood pressure,respiratory rate,SPO2 |
6 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2 |
|
Date of First Enrollment (India)
|
29/06/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Opioids are popular and widely used adjuvant agent in conducting general
anasthesia. Fentanyl is extensively used due to its rapid onset of action, shorter
duration of action and predictable pharmacokinetics and dynamics but it has to
be bought under opioid registry and have serious side effect of respiratory
depression. On the other hand, Nalbuphine and Butorphanol being partial
agonist-antagonist at opioid receptors has no respiratory depression activity
and are not under opioid regulation. But there are inadequate studies of safety
and efficacy of the above mentioned drugs in Indian population.so our aim of
the study is to study the effect of equivalent intravenous dose of Fentanyl, Nalbuphine and Butorphanol on hemodynamic stress response due to
intubation and post-operative analgesia in modified radical mastectomy(MRM)
surgeries. Primary objective of our study is to compare the haemodyanamic response of Fentanyl, Nalbuphine and Butorphanol. Our secondary objective is to assess post-operative
analgesia.
|