| CTRI Number |
CTRI/2024/07/070790 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effect of two drugs on shivering after spinal anaesthesia. |
|
Scientific Title of Study
|
Effect of pre-emptive intravenous dexmedetomidine and paracetamol on post spinal shivering - Randomized double blind study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Preeti Varma |
| Designation |
PG Resident |
| Affiliation |
Department of anaesthesiology and pain medicine, Pt. JNM Medical College Raipur, Chhattisgarh |
| Address |
Department of anaesthesiology and pain medicine, Pt. JNM Medical College, Raipur, Chhattisgarh, PIN- 492001, India.
Raipur
CHHATTISGARH
492001
India |
| Phone |
7415499253 |
| Fax |
|
| Email |
preetivermadr10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Naik Bhuaarya |
| Designation |
Associate Professor |
| Affiliation |
Department of anaesthesiology and pain medicine, Pt. JNM Medical College, Raipur, Chhattisgarh |
| Address |
Department of anaesthesiology and pain medicine, Pt. JNM Medical College, Raipur, Chhattisgarh, PIN-492001, India
Raipur
CHHATTISGARH
492001
India |
| Phone |
7024558098 |
| Fax |
|
| Email |
rashminaik.2007@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Varma |
| Designation |
PG Resident |
| Affiliation |
Department of anaesthesiology and pain medicine, Pt. JNM Medical College, Raipur, Chhattisgarh |
| Address |
Department of anaesthesiology and pain medicine, Pt. JNM Medical College, Raipur, Chhattisgarh, PIN-492001, India
Raipur
CHHATTISGARH
492001
India |
| Phone |
7415499253 |
| Fax |
|
| Email |
preetivermadr10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology and pain medicine, Pt JNM Medical College, Moudahapara, Raipur, Chhattisgarh, India, Pin- 492001 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Pain Medicine Pt JNM Medical college Raipur |
| Address |
In front of central jail, moudahapara, Raipur, C.G. India, Pincode- 492001 |
| Type of Sponsor |
Government 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 Rashmi Naik Bhuaarya |
Dr. Bhimrao Ambedkar Memorial Hospital |
Room no.- 349, 2nd
floor, department of
anaesthesiology and
pain medicine, Raipur,
India, PIN- 492001
Raipur
CHHATTISGARH
Raipur
CHHATTISGARH |
7024558098
rashminaik.2007@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pt J.N.M. Medical College, Raipur (CG) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IV Dexmedetomidine 1mcg/kg |
Group A: IV Dexmedetomidine 1mcg/kg (diluted in 100 ml NS)15 minutes before induction. |
| Comparator Agent |
IV Paracetamol 1g |
Group B: IV Paracetamol 1g 15 minutes prior to induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and ІІ and III
Age 18 to 60 years
BMI less than 30
Patients undergoing elective lower abdominal surgery under SAB |
|
| ExclusionCriteria |
| Details |
Patients refusal to participate
Insufficient blockade
Any comorbidities like uncontrolled cardiovascular or cerebrovascular diseases, renal impairment, severe liver diseases, convulsion or psychiatric disorders, hypo/hyperthyroidism, DM & other autonomic disorders.
Allergy to study drugs
Initial nasopharyngeal temp of more than 38 degree C or less than 35 degree C
Sensory block above T6
Blood transfusion during surgery
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of shivering based on Tsai and Chu score. |
The incidence and duration of shivering will be noted and graded at every 2
minutes after administration of SAB till 20 minutes & at every 5 minutes
thereafter till the completion of surgery. It will be based on Tsai and Chu score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Grades of shivering
• Duration of shivering
• Duration of analgesia
• Side effects and complications (Hypotension, bradycardia, desaturation, nausea
and vomiting and sedation). |
The incidence and duration of shivering will be noted and graded at every 2
minutes after administration of SAB till 20 minutes & at every 5 minutes
thereafter till the completion of surgery. It will be based on Tsai and Chu score |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/07/2024 |
| 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="1"
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
|
Group A: iv Dexmedetomidine 1 μg/kg (diluted in 100 ml NS) and Group B: iv Paracetamol 1 g•On arrival in the OT patients will be positioned in a supine position & multipara monitors will be attached & baseline HR, NIBP, SpO2 & ECG will be recorded. Baseline nasopharyngeal temp will be also noted. A large- bore intravenous cannula will be inserted into forearm and pre-hydration will be done with 500 ml RL which will be kept at room temperature • Study drugs will be prepared and administered by Anaesthesiologist who will not be involved in the study. • Pre-medication: i.v Ondansetron 4 mg + study drug as per the group assigned 15 min prior to administration of SAB. •The incidence and duration of shivering will be noted and graded at every 2 minutes after administration of SAB till 20 minutes & at every 5 minutes thereafter till the completion of surgery. It will be based on Tsai and Chu score |