| CTRI Number |
CTRI/2021/09/036615 [Registered on: 17/09/2021] Trial Registered Prospectively |
| Last Modified On: |
12/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The study is done to compare the effect of nalbuphine and clonidine when added to hyperbaric Bupivacaine Intrathecally in lower abdominal and lower limb surgeries |
|
Scientific Title of Study
|
Comparison of Intrathecal Nalbuphine Versus Clonidine as adjuvants to hyperbaric Bupivacaine in Lower abdominal and Lower Limb surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Simmy John |
| Designation |
Junior Resident |
| Affiliation |
Dr D Y Patil Medical College Hospital and Research Centre |
| Address |
Dr D Y Patil Medical College Hospital and Research Centre
Sant Tukaram Nagar
Pimpri
Pune
Maharashtra
411018
Lucy Cottage
Watts road
Valiathura Po
Trivandrum
695008
Pune
MAHARASHTRA
411018
India |
| Phone |
9995485404 |
| Fax |
|
| Email |
simmyjohn1991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Joshi |
| Designation |
Head of department of anaesthesiology |
| Affiliation |
DR D Y PATIL MEDICAL COLLEGE,PUNE |
| Address |
Dr D Y Patil Medical College Hospital and Research Centre
Sant Tukaram Nagar
Pimpri
Pune
Maharashtra
411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9995485404 |
| Fax |
|
| Email |
smitajoshi6@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simmy John |
| Designation |
Junior Resident |
| Affiliation |
Dr D Y Patil Medical College Hospital and Research Centre |
| Address |
Dr D Y Patil Medical College Hospital and Research Centre
Sant Tukaram Nagar
Pimpri
Pune
Maharashtra
411018
Lucy Cottage
Watts road
Valiathura Po
Trivandrum
695008
Pune
MAHARASHTRA
411018
India |
| Phone |
9995485404 |
| Fax |
|
| Email |
simmyjohn1991@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil Medical College, Hospital and Research centre, Pune |
|
|
Primary Sponsor
|
| Name |
Dr Simmy John |
| Address |
Dr D Y Patil Medical College Hospital and Research Centre
Sant Tukaram Nagar
Pimpri
Pune
Maharashtra
411018 |
| 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 |
| Simmy John |
Dr D Y Patil Medical College Hospital and research centre |
Department of anaesthesiology
Dr D Y Patil Medical College Hospital and research centre
Sant Tukaram
Pimpri
Pune
MAHARASHTRA |
9995485404
simmyjohn1991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub Committee Dr D Y Patil Medical College Hospital And Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K358||Other and unspecified acute appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intrathecal clonidine 30 microgram |
3cc of hyperbaric bupivacaine 0.5% with adjuvant clonidine 30 microgram in spinal anaesthesia in lower abdominal and lower limb surgeries.
Period of study - 18 months |
| Intervention |
Nalbuphine 1.6mg |
3cc of 0.5% hyperbaric bupivacaine with adjuvant nalbuphine 1.6mg in spinal anaesthesia in lower abdominal and lower limb surgeries .
Time for study is 18 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II
Patients posted for lower abdominal and lower limb surgeries
Weight of the patient being in normal range for that age and sex
Patients who are not on any antihypertensive, antiplatelet,fibrinolytic or anticoagulant drugs
Patients who give informed written consent and are willing to be a part of the study |
|
| ExclusionCriteria |
| Details |
1) Patients with pre existing cardiovascular disease ( IHD, hypertension, valvular heart disease), deranged liver functions or renal functions
2) Patients with any Neurological and psychiatric disorders
3) Patients with any contra indication for neuraxial blockade
4) Patients posted for emergency procedures
5) History of allergy to any of the drugs being used under study
6) Unwilling patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
“COMPARISION OF INTRATHECAL NALBUPHINE VS CLONIDINE AS
ADJUVANTS TO BUPIVACAINE IN LOWER ABDOMINAL
AND LOWER LIMB SURGERIES†|
0 minute, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes and 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study and compare changes in various physiological and pharmacological parameters as well
as results achieved, when clonidine is used as adjuvant to intrathecal 0.5% Bupivacaine during Spinal anaesthesia for lower abdominal and lower limb surgeries.
|
0 minute, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes and 30 minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/09/2021 |
| 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="2"
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)?
Response - NO
|
|
Brief Summary
|
It is a randomized,prospective, comparative, double blinded,observational study where in Intrathecal Nalbuphine and Clonidine are compared as adjuvants to hyperbaric Bupivacaine in Lower abdominal and Lower Limb surgeries. |