| CTRI Number |
CTRI/2022/09/045923 [Registered on: 27/09/2022] Trial Registered Prospectively |
| Last Modified On: |
23/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of two adjuvant drugs to prolong spinal anaesthesia |
|
Scientific Title of Study
|
A Comparison between Intrathecal Nalbuphine and Intrathecal Dexmedetomidine as adjuvant to 0.5% hyperbaric bupivacaine for orthopedic surgery of lower limbs under Sub Arachnoid Block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Geetanjali Singhal |
| Designation |
Associate professor |
| Affiliation |
Jaipur National University Institute For Medical Sciences and Research Centre |
| Address |
Jaipur National University Institute For Medical Sciences and Research Centre
Jagatpura
Jaipur
Jagatpura
Jaipur
RAJASTHAN
302017
India |
| Phone |
9829051344 |
| Fax |
|
| Email |
singhalgeetanjali@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetanjali Singhal |
| Designation |
Associate professor |
| Affiliation |
Jaipur National University Institute For Medical Sciences and Research Centre |
| Address |
Jaipur National University Institute For Medical Sciences and Research Centre
Jagatpura
Jaipur
Jagatpura
Jaipur
RAJASTHAN
302017
India |
| Phone |
9829051344 |
| Fax |
|
| Email |
singhalgeetanjali@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetanjali Singhal |
| Designation |
Associate professor |
| Affiliation |
Jaipur National University Institute For Medical Sciences and Research Centre |
| Address |
Jaipur National University Institute For Medical Sciences and Research Centre
Jagatpura
Jaipur
Jagatpura
Jaipur
RAJASTHAN
302017
India |
| Phone |
9829051344 |
| Fax |
|
| Email |
singhalgeetanjali@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Jaipur National University Institute For Medical Sciences and Research Centre
Jaipur |
|
|
Primary Sponsor
|
| Name |
JNUIMSRC |
| Address |
JNUIMSRC
Jagatpura
Jaipur |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Geetanjali Singhal |
JNUIMSRC |
department of anaesthesiolog
orthopedic operation theatre (oT 2 )
Jaipur
RAJASTHAN |
9829051344
singhalgeetanjali@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comittee, Jaipur national university |
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 |
| Comparator Agent |
dexmedetomidine |
bupivacaine spinal anaesthesia with dexmedetomidine as adjuvant
4 mg single dose |
| Comparator Agent |
nalbuphine |
bupivacaine spinal anaesthesia with nalbuphine as adjuvant
2mg single dose |
| Intervention |
spinal anaesthesia |
spinal anaesthesia for orthopedic lower limb surgeries with bupivacaine and either nalbuphine or dexmedetomidine as adjuvant |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
Bleeding diathesis
local infection
severe systemic diseases
spinal deformities and surgery
not willing to give consent |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
onset of sensory and motor blocks
duration of sensory and motor blocks
duration of analgesia |
onset of sensory and motor blocks at 2, 4, 6, and 8 minutes
Duration of analgesia at 2, 3, 4, and 5 hours
duration of sensory and motor blocks at 60, 90, 120, 150, and 180 minutes
duration of analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any side effects |
every 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)
|
30/09/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- 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 - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [singhalgeetanjali@yahoo.com].
- For how long will this data be available start date provided 01-12-2022 and end date provided 01-12-2027?
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
|
60 patients posted for orthopedic surgery of lower limbs under spinal anaesthesia will be studied to compare the effects of intrathecal dexmedetomidine with hyperbaric bupivacaine and intrathecal nalbuphine with hyperbaric bupivacaine. The study will comprise of 2 groups of 30 patients each of ASA grade 1 and 2 status. |