| CTRI Number |
CTRI/2022/12/048178 [Registered on: 16/12/2022] Trial Registered Prospectively |
| Last Modified On: |
14/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of drugs for shivering after spinal anaesthesia |
|
Scientific Title of Study
|
comparative evaluation of dexmedetomidine versus nalbuphine for control of post spinal shivering |
| Trial Acronym |
DEX NAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chhaya Suryawanshi |
| Designation |
professor |
| Affiliation |
dr. d. y patil vidyapeeth |
| Address |
department of anesthesia, dr. d. y. patil vidyapeeth, pune
dr. d. y. patil vidyapeeth
Pune
MAHARASHTRA
411018
India |
| Phone |
9676989293 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
sonalika tudimilla |
| Designation |
junior resident |
| Affiliation |
dr. d.. y. patil vidyapeeth |
| Address |
department of anesthesia dr. d. y. patil vidyapeeth
pimpri pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9676989293 |
| Fax |
|
| Email |
sona3668@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sonalika tudimilla |
| Designation |
junior resident |
| Affiliation |
dr. d.. y. patil vidyapeeth |
| Address |
department of anesthesia dr. d. y. patil vidyapeeth
pimpri pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9676989293 |
| Fax |
|
| Email |
sona3668@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
dr d y patil vidyapeeth pimpri pune |
| Address |
dr. d. y. patil vidyapeeth, pimpri, pune |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| dr d y patil vidyapeeth pimpri pune |
dr. d. y. patil vidyapeeth, pimpri, pune |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonalika Tudimilla |
dr. d. y. patil vidyapeeth, pimpri, pune |
departmetn of anesthesia dr. d. y. patil vidyapeeth, pimpri, pune
Pune
MAHARASHTRA |
9676989293
sona3668@hotmail.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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine |
1 mcg/kg, intravenous for 30 minutes ,control of shivering |
| Comparator Agent |
nalbuphine |
0.05 mg/kg, intravenous, for 30 minutes control of shivering |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I & II.
2. Age between 18 and 60 years of either sex.
3. Patients undergoing surgeries under spinal anaesthesia.
4. Haemodynamically stable patients with all routine investigations within normal limits.
5. Patients who are not on any cardiac related drugs
5. Availability of an informed consent.
|
|
| ExclusionCriteria |
| Details |
. Patient refusal.
2. Patients with ASA physical status III or more.
3. Patients receiving sedative/ hypnotic agents.
4. Patients with uncontrolled hypertension, hyperthyroidism, hypothyroidism, psychiatric disorders, severe diabetes or autonomic neuropathy.
5. Patients with history of cardiac, respiratory, renal or hepatic diseases.
6. Patients with history of alcohol or drug abuse.
7. Patients who have a history of allergy to any of the test drugs.
8. Contraindications to spinal anaesthesia (coagulation disorder, infection at puncture site, raised intracranial tension, pre-existing neurological deficit in lower extremities or any spine deformity).
9. Initial body temperature >38°C or <36°C
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| control of shivering |
baseline, 0, 1, 2, 5, 10, 15, 20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| control of shivering |
baseline, 0, 1, 2, 5, 10, 15, 20 minutes after giving the drug |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/12/2022 |
| 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
|
for the control of shivering |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
two drugs for control of shivering after giving spinal anaesthesia |