| CTRI Number |
CTRI/2024/04/065027 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| 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
|
Investigating the effectiveness of two different drugs in managing intraoperative shivering among patients undergoing surgery under spinal anesthesia |
|
Scientific Title of Study
|
A comparative study to determine the efficacy of dexmedetomidine and nalbuphine for the treatment intraoperative shivering in the patients posted for surgery
Under spinal anaesthesia
|
| 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 Anita Kumari |
| Designation |
Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar |
| Address |
Department of Anaesthesia, Sri Gur Ram Das Institute of Medical Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9815632909 |
| Fax |
|
| Email |
varinderjit72@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar |
| Address |
Department of Anaesthesia, Sri Gur Ram Das Institute of Medical Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
7888922797 |
| Fax |
|
| Email |
sachreetdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Urvashi |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar |
| Address |
Department of Anaesthesia, Sri Gur Ram Das Institute of Medical Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9888298338 |
| Fax |
|
| Email |
urvashijain160@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Gur Ram Das Institute of Medical Sciences and Research |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical Sciences and research |
| Address |
Mehta Road, Vallah |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ruchi Gupta |
Sri Gur Ram Das Institute of Medical Sciences and Research |
Main Operation Theatre, Sri Gur Ram Das Institute of Medical Sciences and Research
Amritsar
PUNJAB |
9814020805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine, Nalbuphine a and Normal saline |
comparison of nalbuphine 0.08 mg/kg and dexmedetomidine 0.3ug/kg diluted in normal saline upto 10 ml given as slow intravenous bolus for treatment of intraoperative shivering with control(normal saline) and vitals will be monitor till end of surgery |
| Intervention |
spinal anaesthesia |
comparison of nalbuphine 0.08 mg/kg and dexmedetomidine 0.3ug/kg diluted in normal saline upto 10 ml given as slow intravenous bolus for treatment of intraoperative shivering.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
a) Allergic to any of the drugs
b) Contraindication to spinal anaesthesia
c) Obese patients BMI more than 30
d) ASA grade 3 and 4
e) Patients with coagulopathy, heart blocks and bradycardia,
f) Pregnant and nursing mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the efficacy of dexmedetomidine and nalbuphine in the treatment of
intraoperative shivering in the patients scheduled for surgery under spinal anaesthesia |
Start from the initiation of anaesthesia till the end of surgery at every 5 min in first half hour and every 15 min till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Time for cessation of shivering in (min) following drug administration
2) Grade of shivering following drug administration.
3) Time for reoccurrence of shivering (min)
4) Time for disappearance of shivering in case of recurrence
5) Side effects
|
Start from the initiation of anaesthesia till the end of surgery at every 5 min in first half hour & every 15 min till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/04/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Introduction: Shivering is commonly observed in patients following subarachnoid block.
Dexmedetomidine is an alpha 2 adrenergic receptor agonist has been observed to
decrease the incidence of shivering in post spinal anaesthesia patients.
Nalbuphine is a synthetic opioid which has both agonist antagonist activity and
is commonly used in treatment of post spinal shivering.
Aim: This study aims to compare, dexmedetomidine and nalbuphine in terms of
clinical efficacy for the treatment of shivering in the patients scheduled for
surgery under spinal anaesthesia.
Material And Method: This randomized control
trial shall be conducted in 90 patients posted for surgery under spinal
anaesthesia. Patients would be further allocated into three groups, group A
(dexmedetomidine), group B (nalbuphine) and group C (placebo), each group
comprising of 30 patients each. Shivering will be graded according to the
Bedside Shivering Assessment Score (BSAS). Time of onset of shivering, severity
of shivering, time to cessation of shivering, time of reoccurrence and side
effects will be noted.
Conclusion: The data generated from this study will be compiled and analyzed
according to appropriate statistical methods. |