| CTRI Number |
CTRI/2024/11/077452 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
comparing effectiveness of two drugs, dexamethasone and paracetamol in preventing shivering after spinal anaesthesia in patients undergoing trans urethral prostrate surgeries. |
|
Scientific Title of Study
|
Comparison of intravenous dexamethasone with intravenous paracetamol, to prevent post spinal shivering, in patients undergoing Trans-urethral resection of Prostate – A Randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul G Bhat |
| Designation |
Junior resident |
| Affiliation |
SDM College of Medical Sciences and Hospital |
| Address |
Anugraha,Netaji road, Chandrika layout, Kadri Kambla, Bejai post, Mangaluru
Dharwad
KARNATAKA
575004
India |
| Phone |
9448389896 |
| Fax |
|
| Email |
rahulganapathibhat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahul G Bhat |
| Designation |
Junior resident |
| Affiliation |
SDM College of Medical Sciences and Hospital |
| Address |
Anugraha,Netaji road, Chandrika layout, Kadri Kambla, Bejai post, Mangaluru
Dharwad
KARNATAKA
575004
India |
| Phone |
9448389896 |
| Fax |
|
| Email |
rahulganapathibhat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul G Bhat |
| Designation |
Junior resident |
| Affiliation |
SDM College of Medical Sciences and Hospital |
| Address |
Anugraha,Netaji road, Chandrika layout, Kadri Kambla, Bejai post, Mangaluru
Dharwad
KARNATAKA
575004
India |
| Phone |
9448389896 |
| Fax |
|
| Email |
rahulganapathibhat@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Medical Sciences and Hospital |
|
|
Primary Sponsor
|
| Name |
SELF |
| Address |
SDM College of Medical Sciences and Hospital, Manjushree Nagar, Sattur, Dharwad-580 009. |
| 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 |
| DrVishwajeet Korikanthimath |
Biomedcentral.com |
Department of Anesthesia and Intensive Care, Faculty of Medicine, AinShams University, Cairo, Egypt. 2
Community Medicine Department, National
Research Centre, Cairo, Egypt.
Dharwad
KARNATAKA |
8147273130
vishwavkmath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group D |
Group D – 4 milligrams Dexamethasone in 100mL normal saline given after spinal, over 5 minutes.
|
| Intervention |
Group P |
Group P – 1 gram Paracetamol in 100mL normal saline given after spinal, over 5 minutes. |
| Comparator Agent |
Group S |
Group S- 100mL of Normal saline given after spinal, over 5 minutes. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1.All patients posted for Trans Urethral Resection of Prostate procedure.
2.The patients who belong to American Society of Anesthesia 1, 2 and 3 physical statuses.
|
|
| ExclusionCriteria |
| Details |
1.Patients with spinal deformity.
2.Patients with allergic history to the drugs used in this study.
3.Any contraindication to subarachnoid block.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Incidence of shivering
2.Severity of shivering
3.Time to first onset of shivering
4.Total consumption of anti-shivering medication (IV Pethidine)
|
TIME POINT A: Pre operative value during pre anaesthetic evaluation
TIME POINT B : Prior to spinal anaesthesia
TIME POINT C : Intra operatively for every 5 minutes upto 30 minutes from onset of spinal anaesthesia
TIMEPOINT D : For every 30 minutes upto 180 minutes frm he onset of spinal anaesthesia in he post operative period
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• side effects such as nausea, vomiting (treated using Metoclopramide 10 mg IV) will be recorded & considered as secondary outcome & treated accordingly.
• Any serious adverse events such as anaphylactic or cardiac arrest during monitoring would be managed immediately & reported to the ethics committee.
|
Temperature & shivering will be monitored every 5 minutes for 30 minutes & every 30 minutes for 2 & half hours. |
|
|
Target Sample Size
|
Total Sample Size="153"
Sample Size from India="153"
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)
|
09/12/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study proposal aims to compare the efficacy of intravenous dexamethasone with intravenous paracetamol in preventing post-spinal shivering in patients undergoing transurethral resection of the prostate (TURP). There is a high prevalence of hypothermia and shivering in TURP surgeries, particularly in older patients with comorbidities. The rationale underscores the lack of a definitive treatment for post-spinal shivering and proposes dexamethasone and paracetamol as potential interventions due to their mechanisms of action. The novelty lies in comparing these drugs specifically in the context of TURP surgeries. The expected outcome is a decreased incidence of post-spinal shivering and its adverse effects. The research question revolves around whether paracetamol is more effective than dexamethasone in preventing post-spinal shivering or vice versa. The primary objective is to evaluate the Incidence, Time of onset, severity of post-spinal shivering, in TURP after the administration of paracetamol or dexamethasone and requirement of IV Pethidine for treatment of grade 3 or 4 shivering (according to Crossley and Mahajan shivering grades) . Secondary objectives include studying the side effects of the drugs - Nausea, vomiting and Hypotension. |