| CTRI Number |
CTRI/2018/02/012125 [Registered on: 23/02/2018] Trial Registered Prospectively |
| Last Modified On: |
02/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of drug nalbuphine and tramadol used for shivering after spinal anaesthesia |
|
Scientific Title of Study
|
Randomised double blind comparitive
study of intravenous nalbuphine and tramadol 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 |
DEEPAK KUMAR NIRALA |
| Designation |
MD TRAINEE |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences Patna |
| Address |
Dept Of Anaesthesiology
Indira Gandhi Institute Of Medical Sciences Patna Bihar SHEIKHPURA PATNA BIHAR Patna BIHAR 800014 India |
| Phone |
8368093616 |
| Fax |
|
| Email |
dknirala2k9@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K H RAGHWENDRA |
| Designation |
PROFESSOR |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences |
| Address |
Dept Of Anaesthesiology
Indira Gandhi Institute Of Medical Sciences Patna Bihar SHEIKHPURA PATNA BIHAR Patna BIHAR 800014 India |
| Phone |
9835092798 |
| Fax |
|
| Email |
dr.khraghwendra@ymail.com |
|
Details of Contact Person Public Query
|
| Name |
DEEPAK KUMAR NIRALA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences Patna |
| Address |
Dept Of Anaesthesiology
Indira Gandhi Institute Of Medical Sciences Patna Bihar SHEIKHPURA PATNA BIHAR Patna BIHAR 800014 India |
| Phone |
8368093616 |
| Fax |
|
| Email |
dknirala2k9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology,IGIMS,Patna. |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiologyIGIMSPatna |
| Address |
First floor,Ward block,IGIMS,Sheikhpura,Patna,Bihar. |
| 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 |
| Deepak kumar Nirala |
Neuro OT Complex |
First floor,Ward block,IGIMS,Sheikhpura,Patna,Bihar. Patna BIHAR |
8368093616
dknirala2k9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nalbuphine |
IV Nalbuphine 0.06 mg/kg in 5 ml normal saline. |
| Comparator Agent |
Tramadol |
IV Tramadol 1mg/kg in 5ml normal saline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of ASA physical status I &II
2.Age between 18-50 yrs of age of either sex who have undergone routine general, orthopaedic, or gynaecological and obstetrical surgery under spinal anaesthesia.
3.Post anaesthetic shivering occurring within 10min of admission to recovery room
|
|
| ExclusionCriteria |
| Details |
1.<18 yrs of age& >50 yr of age
2.Post anaesthetic shivering occurring after 10 min of admission to recovery room
3.Known hyperthyroidism, cardiopulmonary or neuromuscular pathology
4.Patients with contraindication for the use of Nalbuphine and Tramadol will not be included
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the effectiveness of intravenous nalnupine and tramadol for post spinal anaesthesia shivering.
|
0min,5min,10min,15min,20min,25min,30min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the adverse effects if any.
2.To compare any haemodynamic changes
|
0min,5min,10min,15min,20min,25min,30min |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
27/02/2018 |
| Date of Study Completion (India) |
30/08/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet Published. Willing to Publish |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Background and Aims: The present study designed to compare the
clinical efficacy, hemodynamic and side effects of nalbuphine and tramadol,
when used for control of post‑spinal anesthesia shivering.
Methods: A prospective, randomised, and double‑blind study was conducted in 90 American Society of Anesthesiologists
Grade I and II patients of either gender, aged between 18-60 years, who
subsequently developed shivering grade 3 or 4, scheduled for various surgical
procedures under spinal anesthesia. The patients were randomized into two groups of 45 patients each to
receive either nalbuphine 0.06 mg/kg (Group N) or tramadol 1 mg/kg (Group T). Grade of shivering, onset of shivering, time interval
for cessation of shivering, response rate at 5 min and 30 min, rescue dose,
hemodynamic parameters and adverse effects were observed at scheduled
intervals. Independent t‑test was used for analysing the data.
Results: Time taken for cessation of shivering was significantly less with nalbuphine
when compared to tramadol (p<0.05). It
was observed that the response time at 5 min and 30 min and rescue dose
requirement for control of shivering was not much difference (p>0.05).
However, sedation was significantly more in the nalbuphine group and tramadol significantly
causes more nausea and vomiting.
Conclusion: Both
nalbuphine (0.06 mg/kg) and tramadol (1 mg/kg) are effective in treating
patients with post‑spinal
anesthesia shivering. However, the time taken for cessation of shivering is significantly less with nalbuphine
when compared to tramadol. Furthermore, tramadol causes significantly more
nausea and vomiting, however, nalbuphine causes significantly more sedation.
Key words: Nalbuphine,
post‑spinal anesthesia shivering, tramadol |