| CTRI Number |
CTRI/2020/09/027985 [Registered on: 23/09/2020] Trial Registered Prospectively |
| Last Modified On: |
22/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between the effects of intravenous clonidine and dexmedetomidine on shivering after spinal anaesthesia |
|
Scientific Title of Study
|
A prospective randomised double-blind comparative study between intravenous clonidine And dexmedetomidine for post-spinal anaesthesia shivering |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mallika Mondal |
| Designation |
Post graduate trainee |
| Affiliation |
Midnapore Medical College and Hospital |
| Address |
Department of Anaesthesiology
Midnapore Medical College and Hospital,
Paschim Medinipur,Medinipur
Medinipur
WEST BENGAL
721101
India |
| Phone |
9007853882 |
| Fax |
|
| Email |
molly12101988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suman Chattopadhyay |
| Designation |
Professor and HOD |
| Affiliation |
Midnapore Medical College and Hospital |
| Address |
Department of Anaesthesiology Midnapore Medical College and Hospital,
Paschim Medinipur,Medinipur
Medinipur
WEST BENGAL
721101
India |
| Phone |
7044072472 |
| Fax |
|
| Email |
sumanc24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suman Chattopadhyay |
| Designation |
Professor and HOD |
| Affiliation |
Midnapore Medical College and Hospital |
| Address |
Department of Anaesthesiology
Midnapore Medical College and Hospital,
Paschim Medinipur,Medinipur
Medinipur
WEST BENGAL
721101
India |
| Phone |
7044072472 |
| Fax |
|
| Email |
sumanc24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Office of the principal,Midnapore medical college and hospital,Vidyasagar road.Paschim Medinipur-721101 |
|
|
Primary Sponsor
|
| Name |
Midnapore Medical College |
| Address |
Midnapore Medical College,Paschim Medinipur,medinipur,West Bengal-721101
|
| 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 |
| Mallika Mondal |
Midnapore medical college and hospital |
Department of Anaesthesiology,Midnapore medical college and hospital, Paschim Medinipur,medinipur
Medinipur
WEST BENGAL |
9007853882
molly12101988@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: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Effects of intravenous clonidine on shivering after spinal anaesthesia. |
Another group of 27 patients will receive intravenous clonidine 0.5mcg/kg after onset of post spinal shivering. |
| Intervention |
Effects of intravenous dexmedetomidine on shivering after spinal anaesthesia |
One group of 27 patients will receive intravenous dexmedetomidine 0.5mcg/kg after onset of post spinal shivering. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age- 18-60 years
2. ASA grade 1 & 2
3. OT temp between 24 to 32 degree
4. Gynaecology and obstetrics, surgery, and
orthopaedic operations
|
|
| ExclusionCriteria |
| Details |
1. Preexisting cardiac diseases
2. Pulmonary diseases
3. Bleeding or coagulation disorders
4. Renal or hepatic disease
5. Neuromuscular disorder
6. Psychiatric disorder
7. Hyperthyroidism
8. Deformity of the spinal column
9. Urinary tract infection
10.Severe diabetes or autonomic neuropathies
11.Known history of substance or alcohol abuse
12 Patient receiving any premedication
13.Cutaneous infection
14.Contraindication of spinal anaesthesia
15.Conversion to GA at any time intraoperatively
16.Patient refusal
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
We will compare the effects of clonidine and dexmedetomidine on shivering in terms of time of cessation of shivering,
response rate and recurrence rate of shivering following spinal anaesthesia
|
At baseline and at intervals of every 5 min for first 30 min and every 15 min for rest of the observation period after starting point of shivering. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| We will observe the change in blood pressure, heart rate, respiratory depression, nausea vomiting, dry mouth, effect of sedation in patients who will receive clonidine and dexmedetomidine separately. |
At baseline and at intervals of every 5 min for first 30 min and every 15 min for rest of the observation period after starting point of shivering. |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
28/09/2020 |
| 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="6"
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
|
The aim of this study is to evaluate
and compare the efficacy, haemodynamics and adverse effects of dexmedetomidine
with those of clonidine, when used for control of post spinal anaesthesia
shivering during the intraoperative period. 54 American Society of Anaesthesiologist
grade I and II patients of either sex, aged 18-60 years, scheduled for
surgeries under spinal anaesthesia will be randomised into two groups of 27
patients each. One group will receive dexmedetomidine 0.5mcg/kg , other group
will receive clonidine 0.5mcg/kg. Grade of shivering, time of cessation of
shivering, response rate, recurrence rate and adverse effects will be
observed at scheduled intervals. |