| CTRI Number |
CTRI/2019/11/022059 [Registered on: 19/11/2019] Trial Registered Prospectively |
| Last Modified On: |
28/11/2019 |
| 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
|
To compare effect of drug Fentanyl and Nalbuphine when given with bupivacaine in below umblical surgeries in spinal anaesthesia |
|
Scientific Title of Study
|
To compare effect of Fentanyl and Nalbuphine as adjuvant to Bupivacaine in below umblical surgeries in spinal anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akash Verma |
| Designation |
PG Resident |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesia, Peoples hospital, Bhanpur, Bhopal
Department of Anaesthesia, Peoples hospital, Bhanpur, Bhopal
Bhopal
MADHYA PRADESH
462010
India |
| Phone |
8109251089 |
| Fax |
|
| Email |
akashverma366@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay P Dave |
| Designation |
Professor & HOD |
| Affiliation |
Peoples college of medical sciences and research centre |
| Address |
Department of Anaesthesia, Peoples hospital, Bhanpur, Bhopal
Department of Anaesthesia, Peoples hospital, Bhanpur, Bhopal
Bhopal
MADHYA PRADESH
462010
India |
| Phone |
08959044424 |
| Fax |
|
| Email |
sanjaydave00@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akash Verma |
| Designation |
PG Resident |
| Affiliation |
Peoples college of medical sciences and research centre |
| Address |
Department of Anaesthesia, Peoples hospital, Bhanpur, Bhopal
Department of Anaesthesia, Peoples hospital, Bhanpur, Bhopal
Bhopal
MADHYA PRADESH
462010
India |
| Phone |
8109251089 |
| Fax |
|
| Email |
akashverma366@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akash Verma, PG Resident ,PCMS Campus ,Bhanpur , Bhopal. |
|
|
Primary Sponsor
|
| Name |
Akash verma |
| Address |
PCMS Campus, Bhanpur, Bhopal |
| 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 |
| Akash Verma |
Peoples Hospital |
Department of Anaesthesia, Peoples hospital, Bhanpur, Bhopal
Bhopal
MADHYA PRADESH |
8109251089
akashverma366@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMITTEE , PCMS &RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S720||Fracture of head and neck of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nalbuphine 1mg and Fentanyl 25mcg |
Comparing effect as adjuvant to Bupivacaine 0.5% 3.5 ml, in below umblical surgeries. |
| Comparator Agent |
Nalbuphine 1mg, and Fentanyl 25 mcg |
Comparing effect as adjuvant to bupivacaine 0.5% 3.5ml in below umblical surgeries. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 & 2, age group 21 -60 years, height 150-170 cm, weight 40-75 kg, patients admitted to lower limb surgeries, expected duration of surgery 120-150 min. |
|
| ExclusionCriteria |
| Details |
ASA grade 3&4, allergy to study drugs, HR,50/MIN, SBP, 100 mm hg, patients on narcotic or any other sedative drugs, contraindication to regional anaesthesia. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post Operative Pain Evaluations. |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post Operative Pain Evaluation. |
30 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/11/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
To compare effect of fentanyl and nalbuphine in prolonging the duration of spinal anaesthesia as adjuvant to bupivacaine , drug which provide more duration of anaesthesia may be used in longer duration of surgeries .
|