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CTRI Number  CTRI/2023/02/049546 [Registered on: 08/02/2023] Trial Registered Prospectively
Last Modified On: 07/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To know the effect of drug Nalbuphine and Ketamine in treating shivering in patients coming for below abdomen Surgeries 
Scientific Title of Study   A study of Comparison of Nalbuphine versus Ketamine for treating post-anesthesia shivering after spinal anaesthesia in patients undergoing infraumbilical surgeries 
Trial Acronym  not applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gayatri CK 
Designation  Senior resident 
Affiliation  ESIC Medical college, Kalaburagi  
Address  ESIC MC, GULBARGA, SEDAM ROAD, 585105
ESI Medical college and hospital, Sedam road, Kalaburagi 585106
Gulbarga
KARNATAKA
585105
India 
Phone  9916571034  
Fax  08472265545  
Email  ck.gayatri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sumalatha GB 
Designation  Professor 
Affiliation  ESI medical college and hospital 
Address  ANAEDTHESIA DEPARTMENT, ESIC MC, GUULBARGA, SEDAM ROAD,
Department of Anesthesiology, Sedam road, Kalaburagi
Gulbarga
KARNATAKA
585102
India 
Phone  9538301444  
Fax  08472265545  
Email  gbsumaravi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gayatri CK 
Designation  Senior resident 
Affiliation  ESI medical college and hospital 
Address  ESIC MEDICAL COLLEGE, GULBARGA, SEDAM ROAD,
Third floor, OT Complex, ESIC MC, Department of anesthesiology, Sedam road, Kalaburagi
Gulbarga
KARNATAKA
585103
India 
Phone  9916571034  
Fax    
Email  ck.gayatri@gmail.com  
 
Source of Monetary or Material Support  
ESIC Medical college, Gulbarga 
 
Primary Sponsor  
Name  ESI medical college and hospital 
Address  ESI medical college and hospital, Sedam road Kalaburagi 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Gayatri CK   ESI medical college operation theatre  ESI medical college and research institute, Thgird floor, Department of Anesthesiology, OT complex, sedam road, Kalaburagi
Gulbarga
KARNATAKA 
9916571034

ck.gayatri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Administering KetAMINE 0.25 MG/KG intravenously   THIS group will receive NKetamine intravenously after assessing the grading of shivering 15 MIN INTERVAL TILL THE END OF SURGERY.  
Intervention  Administering Nalbuphine 0.1MG/KG intravenously  dose 0.1 mg/kg of Nalbuphine WILL be given intravenously AND SHIVERING WILL BE ASSESSED AT 15 MIN INTERVALS TILL THE END OF SURGERY  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patient’s belonging to ASA 1 and 2
Scheduled for infra umbilical surgeries
Patient’s without having any comorbidities 
 
ExclusionCriteria 
Details  Patients belonging to ASA3 or more
Pregnant women
Patients less than 18 years
Patient not willing 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
1) Shivering score


 
T1: 10 minutes after spinal anesthesia
T2: 20 minutes after spinal anesthesiaT3 within 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Any side effects - To assess any side effects like respiratory depression, urinary retention, nausea, vomiting, sedation, pruritus, drowsiness, hallucination and delirium will be noted.
 
T1: Post operatively every 2nd hourly till 24 hours 
 
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)   13/02/2023 
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   Not published  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Title of the research work:
Comparision of Nalbuphine versus Ketamine for treating post anaesthtic shivering after spinal anaesthesia in patients undergoing infra umbilical surgeries
Introduction and Need for the study:
Shivering is known to be a frequent complication, reported in 40 to 70 % of patients undergoing surgery under regional anesthesia.(1,2) Post-anesthetic shivering is spontaneous involuntary, rhythmic, oscillating, tremor-like muscle hyperactivity that increases metabolic heat production up to 600% after general or regional anesthesia .(3) Post anesthetic shivering may cause discomfort to patients, and aggravate wound pain by stretching incisions and increase intracranial (4) and intraocular (5) pressure. Various methods are available for control of shivering; these may be non pharmacological or pharmacological methods using drugs which have anti-shivering properties.
Nalbuphine, a semisynthetic opioid related to both Naloxone and Oxymorphone, has the characteristics of μ-antagonist and κ-agonist activities. It has a high affinity for κ-opioid receptors in the central nervous system. Therefore, Nalbuphine got a significant effect on post spinal anesthesia shivering. But Nalbuphine associated with many side effects like respiratory depression, urinary retention, nausea, vomiting, sedation and pruritus (6-9)
Ketamine has also been used as an anti-shivering drug. It is a non-competitive N-methy-D-aspartate (NMDA) receptor antagonist. Ketamine increases arterial pressure, heart rate, and cardiac output because of direct central sympathetic stimulation and inhibition of norepinephrine uptake into postganglionic sympathetic nerve endings, and may decrease core-to-peripheral redistribution of heat(10). Thus helps in prevention of shivering.
It is used as antishivering agent in dose of 0.5-0.75mg kg-1 IV. But even in these doses it causes side effects i.e. drowsiness, hallucination and delirium.(11-14)
So we conducted the present study to evaluate and compare the relative efficacy and safety of low dose Ketamine (0.25 mg/kg) and Nalbuphine (0.1mg/kg) for prevention of shivering in ASA 1 and 2 patients during spinal anaesthesia.
Objectives:
1) Primary objective- To evaluate and compare the relative efficacy and safety of low dose Ketamine (0.25 mg/kg) and Nalbuphine (0.1mg/kg) for prevention of shivering in ASA 1 and 2 patients during spinal anaesthesia.
2) Secondary objective- To assess any side effects like respiratory depression, urinary retention, nausea, vomiting, sedation and pruritus due to Nalbuphine and drowsiness, hallucination and delirium due to Ketamine .

 
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