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
|
|
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
|
|
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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