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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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


 
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