| CTRI Number |
CTRI/2021/09/036386 [Registered on: 09/09/2021] Trial Registered Prospectively |
| Last Modified On: |
07/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison between two drugs for post spinal shivering |
|
Scientific Title of Study
|
Comparative evaluation of nalbuphine and tramadol for control of post spinal anaesthesia shivering |
| Trial Acronym |
NAL TRAM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonalika Tudimilla |
| Designation |
junior resident |
| Affiliation |
dr. d. y patil vidyapeeth |
| Address |
Dr. D. Y. Patil medical college and research centre
Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9676989293 |
| Fax |
|
| Email |
sona3668@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chhaya suryawanshi |
| Designation |
Professor |
| Affiliation |
dr. d. y patil vidyapeeth |
| Address |
Dr. D. Y. Patil medical hospital and research centre, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonalika Tudimilla |
| Designation |
junior resident |
| Affiliation |
dr. d. y patil vidyapeeth |
| Address |
Dr. D. Y. Patil medical hospital and research centre, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9676989293 |
| Fax |
|
| Email |
sona3668@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y Patil medical hospital and research centre |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil medical college |
| Address |
Dr. D. Y. Patil medical college and research centre Pune |
| 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 |
| Dr Sonalika Tudimilla |
Dr. D. Y. Patil medical hospital and research centre |
operation theatre, 5th floor
Pune
MAHARASHTRA |
9676989293
sona3668@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics sub 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 |
| Comparator Agent |
Nalbuphine |
0.05mg/kg post spinal shivering
4 hrs |
| Intervention |
Post spinal shivering |
Two drugs for post spinal shivering |
| Comparator Agent |
Tramadol |
0.5mg/kg diluted in ns for post spinal shivering for 3 hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing surgeries under spinal anaesthesia
Stable asa I and II patients |
|
| ExclusionCriteria |
| Details |
1.Patients not willing to get enrolled in this study.
2.Patients with ASA physical status III or more.
3. Patients below 18 years and above 60 years of age.
4. Patients posted for emergency procedures.
5.Patients with uncontrolled systemic disorders like diabetes mellitus, heart disease, chronic hypertension, pulmonary disorders, etc.
6.Patients with spine deformities or local skin interactions overlying the lumbar vertebral region.
7.Patients with bleeding or coagulation disorders.
8.Patients with known allergies to the study drugs.
9.Patients with history of alcohol or drug abuse. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Wrench grade -0-1
Ramsay Sedation score 1-2 |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of drugs from Onset of shivering post spinal and duration |
1 year and 2 years |
|
|
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)
|
23/09/2021 |
| 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
|
yet to be published |
|
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
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sona3668@hotmail.com].
- For how long will this data be available start date provided 07-01-2022 and end date provided 07-07-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Post spinal anaesthesia, Patients who developed either Grade 3 or 4 shivering lasting for a minimum period of 2 minutes, were included in the study. Injection nalbuphine 0.05mg/kg or Injection Tramadol 0.5 mg/kg were diluted to a volume of 10 ml in a 10 ml syringe and presented as coded syringes as per randomization list by an anesthesiologist who was unaware of the group allocation. This was then administered to the patient as a slow IV injection over a period of 10 minutes. All the hemodynamic parameters monitored.
|