CTRI Number |
CTRI/2021/06/034048 [Registered on: 07/06/2021] Trial Registered Prospectively |
Last Modified On: |
04/06/2021 |
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 of intravenous Magnesium sulfate and intravenous Tramadol for prevention of post spinal shivering in patients undergoing lower limb Orthopedic surgery. |
Scientific Title of Study
|
To compare the prophylactic effect of intravenous Magnesium sulfate with intravenous Tramadol on post spinal shivering for patients undergoing lower limb orthopaedic surgery under spinal anaesthesia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Satyajeet Singh |
Designation |
PG Resident |
Affiliation |
Peoples college of medical sciences and research centre |
Address |
Department of anaesthesia Peoples Hospital PCMS and RC Bhanpur Bhopal Department of anaesthesia Peoples Hospital PCMS and RC Bhanpur Bhopal Bhopal MADHYA PRADESH 462021 India |
Phone |
8959257243 |
Fax |
|
Email |
satya_jeet97@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Mahima Batra |
Designation |
Professor |
Affiliation |
Peoples college of medical sciences and research centre |
Address |
Department of anaesthesia Peoples Hospital PCMS and RC Bhanpur Bhopal Department of anaesthesia Peoples Hospital PCMS and RC Bhanpur Bhopal Bhopal MADHYA PRADESH 462010 India |
Phone |
9752075418 |
Fax |
|
Email |
drmahimabatra@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Mahima Batra |
Designation |
Professor |
Affiliation |
Peoples college of medical sciences and research centre |
Address |
Department of anaesthesia Peoples Hospital PCMS and RC Bhanpur Bhopal Department of anaesthesia Peoples Hospital PCMS and RC Bhanpur Bhopal Sagar MADHYA PRADESH 462010 India |
Phone |
9752075418 |
Fax |
|
Email |
drmahimabatra@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Satyajeet Singh |
Address |
Department of Anaesthesia, Peoples Hospital, PCMS&RC, Bhanpur, Bhopal |
Type of Sponsor |
Other [Self] |
|
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 |
Satyajeet Singh |
Peoples Hospital |
Department of Anaesthesia, Peoples Hospital PCMS & RC,Bhanpur Bhopal Bhopal MADHYA PRADESH |
8959257243
satya_jeet97@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committe |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, (2) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, (3) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Magnesium sulfate (30mg/kg) |
To compare the efficacy of intravenous(iv) Magnesium sulfate(30mg/kg) with intravenous(iv) Tramadol(1mg/kg) on postspinal shivering for patients undergoing lower limb orthopaedic surgeries under spinal anaesthesia. |
Comparator Agent |
Tramadol (1 mg/kg) |
To compare the efficacy of intravenous(iv) Magnesium sulfate(30mg/kg) with intravenous(iv) Tramadol (1mg/kg) on postspinal shivering for patients undergoing lower limb orthopaedic surgeries under spinal anaesthesia. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1.American Society of Anesthesiologists’ Physical Status I & II.
2.Patients posted for lower limb orthopaedic surgery under spinal anesthesia in Peoples Hospital. |
|
ExclusionCriteria |
Details |
1.American Society of Anesthesiologists’ physical Status III & IV.
2.Patients with Severe cardiopulmonary, renal or liver disease
3.Morbidly obese patients
4.Basal body temperature of patiens >38°C or <36°C
5.Those who received blood transfusion or >2500 ml fluid
6.Patients Allergic to study drug
7.Patients refusing to give consent
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Tramadol and Magnesium sulfate both are equally effective in postspinal shivering. |
1 hour |
|
Secondary Outcome
|
Outcome |
TimePoints |
Tramadol and Magnesium sulfate both are equally effective in postspinal shivering. |
1 hour |
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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)
|
15/06/2021 |
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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Shivering being one of the most common complication of spinal anesthesia, we want to compare the efficacy of intravenous Magnesium sulfate with intravenous Tramadol on patients undergoing lower limb orthopaedic surgeries under spinal anaesthesia for postspinal shivering. The purpose of study to find the most efficient drug among them. |