| CTRI Number |
CTRI/2018/07/014854 [Registered on: 13/07/2018] Trial Registered Prospectively |
| Last Modified On: |
29/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO COMPARE EFFICACY OF DEXMEDETOMIDINE AND NALBUPHINE FOR TREATMENT OF POSTSPINAL SHIVERING |
|
Scientific Title of Study
|
COMPARATIVE STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS DEXMEDETOMIDINE AND NALBUPHINE FOR TREATMENT OF POST SPNIAL SHIVERING |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harpreet kaur |
| Designation |
Junior Resident |
| Affiliation |
GGS Medical college and hospital |
| Address |
Anaesthesia department maint operation theater 2nd floor ggsmc and hospital faridkot
Anaesthesia department main operation theater ggs medical college ans hospital , sadiq road, faridkot.
Faridkot
PUNJAB
151203
India |
| Phone |
9876323555 |
| Fax |
|
| Email |
harpreetk555.gill@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvjeet Kaur |
| Designation |
Proffesor, M.D Anesthesia |
| Affiliation |
GGS medical college and hospital |
| Address |
Anaesthesia department main operation theater 2nd floor ggs medicalcollege and hospital sadiq road faridkot
ggs medical college, sadiq road, faridkot.
Faridkot
PUNJAB
151203
India |
| Phone |
9915680508 |
| Fax |
|
| Email |
drsarvjeetk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarvjeet Kaur |
| Designation |
Proffesor, M.D Anesthesia |
| Affiliation |
GGS medical college and hospital |
| Address |
Anaesthesia department main operation theater 2nd floor ggs medical ollege and hospital faridkot
ggs medical college, sadiq road, faridkot.
Faridkot
PUNJAB
151203
India |
| Phone |
9915680508 |
| Fax |
|
| Email |
drsarvjeetk@gmail.com |
|
|
Source of Monetary or Material Support
|
| GGS medical college and hospital, sadiq road, faridkot, punjab |
|
|
Primary Sponsor
|
| Name |
Dr Harpreet kaur |
| Address |
room no 87, pg girls hostel, medical campus, faridkot. |
| 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 |
| Dr Harpreet Kaur |
GGS Medical college and hospital |
Anaesthesia department main operation theater 2nd floor GGS medical college and hospital, sadiq road, faridkot
Faridkot
PUNJAB |
9876323555
harpreetk555.gill@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Thesis and Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients posted for elective surgery under spinal anaesthesia who develop post spinal shivering , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE, |
INTRAVENOUS DEXMEDETOMIDINE GIVEN DOSE 0.5micro gm /kg OVER 2 MIN |
| Comparator Agent |
NALBUPHINE |
INTRAVENOUS NALBUPHINE GIVEN DOSE 0.08 mg/kg OVER 2 MIN |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I-II
Patients during elective surgeries who develop
post spinal shivering
|
|
| ExclusionCriteria |
| Details |
1.Patient’s refusal for surgery under spinal anaesthesia
2.Any Contraindication to regional anaesthesia
3.Known hypersensitivity to dexmedetomidine or nalbuphine
4.ASA grade III and IV
5.Shivering due to allergic reaction to blood / blood products and other drugs administered during surgery.
6.Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Response time,
success rate,
Recurrence of shivering after success |
every 5 mins for 30 mins and every 15 mins upto 120 mins after spinal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemodynamic parameters,
Adverse Effects |
every 5 mins for 30 mins and every 15 mins upto 120 mins after spinal |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/07/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1.Ozaki M, Kurz A, Sessler DI, et al. Thermoregulatory thresholds during spinal and epidural anesthesia. Anesthesiology 1994;81:282-288.
2.De Whitte, Sessler DI. Perioperative shivering: Physiology and Pharmacology. Anaesthesiology 2002;96:467-484.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
SUMMARY A COMPARATIVE STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS DEXMEDETOMIDINE AND NALBUPHINE FOR TREATMENT OF POST SPINAL SHIVERING
INTRODUCTION : Shivering is one of the most common complications of a central neuraxial blockade. In this study we aim to compare the efficacy of intravenous dexmedetomidine and nalbuphine for treatment of post spinal shivering in terms of response time,success rate and recurrence of shivering .Along with this we will also compare haemodynamic and adverse effects of these drugs PURPOSE OF STUDY The aim of study is to compare the efficacy of intravenously administered dexmedetomidine and nalbuphine in treatment of shivering after spinal anaesthesia in terms of 1. Response time ( time of complete disappearance of shivering after treatment ). 2. Success rate ( if cessation of shivering occur with in 15 min of treatment). 3. Recurrence of shivering after success. 4.Haemodynamic effects.5.Adverse effects. REFERENCESR1. Paner M, Murugaiyan P, Rao SV. A comparative study of intravenous dexmedetomidine and intravenous clonidine for post spinal shivering in patients undergoing lower limb orthopaedic surgeries. Anesth Essays Res. 2017;11:151-4 2. BajwaSJ,Gupta S, Kaur J, Singh A,ParmarS.Reduction in the incidence of shivering with perioperative dexmedetomidine: A randomised prospective study. J Anaesthesiol Clin Pharmcol. 2012;28:86-91. 3. Mittal G, Gupta K, Katyal S, Kaushal S.Randomised double blind comparative study of dexmedetomidine and tramadol for post spinal shivering. Indian J anaesth. 2014;58(3):257-62. 4. Singh S, Verma V K, Parsad C, Parkash J. Randomized double blind comparative study of dexmedetomidine and tramadol for prevention of post operative shivering in transurethral resection of prostrate under spinal anaesthesia. J Evolution. Med. Dent. Sci. 2016;5(13):572-5. |