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CTRI Number  CTRI/2024/08/072116 [Registered on: 08/08/2024] Trial Registered Prospectively
Last Modified On: 05/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison between two drugs for preventing shivering after giving spinal anaesthesia in lower abdominal surgeries 
Scientific Title of Study   Comparison of prophylactic administration of Ondansetron and Dexmedetomidine for the prevention of post-spinal anaesthesia shivering in lower abdominal surgeries : A randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  APOORVA SINGH 
Designation  Post Graduate Trainee 
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal

Imphal West
MANIPUR
795004
India 
Phone  8299493158  
Fax    
Email  drapoorvasingh15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Gojendra Rajkumar 
Designation  Professor and Head 
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal

Imphal West
MANIPUR
795004
India 
Phone  9862824562  
Fax    
Email  gojendrar68@gmail.com  
 
Details of Contact Person
Public Query  
Name  Gojendra Rajkumar 
Designation  Professor and Head 
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal

Imphal West
MANIPUR
795004
India 
Phone  9862824562  
Fax    
Email  gojendrar68@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur, India. Pin code: 795004 
 
Primary Sponsor  
Name  Apoorva Singh 
Address  Regional Institute of Medical Sciences, Imphal, Manipur 
Type of Sponsor  Other [(Self) Post Graduate Trainee] 
 
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 Apoorva Singh  Regional Institute of Medical Sciences, Imphal West, Manipur  Elective surgery Operation Theatre complex (OT 1-8), Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur
Imphal West
MANIPUR 		 8299493158

drapoorvasingh15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board, Regional Institute of Medical Sciences, Imphal, Manipur  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, (2) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj. Dexmedetomidine  Study participants will be randomized into three groups. Group C will receive 1 mcg/kg Dexmedetomidine diluted to a volume of 5 ml, by intravenous route over five minutes just after giving spinal anaesthesia. 
Intervention  Inj. Ondansetron  Study participants will be randomized into three groups. Group B will receive 0.1 mg/kg Ondansetron diluted to a volume of 5 ml, by intravenous route over five minutes just after giving spinal anaesthesia. 
Comparator Agent  Normal saline  Study participants will be randomized into three groups. Group A will receive 5 ml Normal saline by intravenous route over five minutes just after giving spinal anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of age group 18 to 60 years.
2. Patients of American Society of Anaesthesiologists (ASA) grade I or II. 
 
ExclusionCriteria 
Details  1. Patients with history of allergy to Ondansetron and Dexmedetomidine.
2. Patients with history of diabetes, hypertension, thyroid disorder, cardiovascular, respiratory, renal, hepatic or neurological disease.
3. Patients with pregnancy.
4. Patients with body temperature less than 36.5 degree Celsius or more than 38 degree Celsius.
5. Patients with local site infection.
6. Patients with spinal deformity.
7. Patients with bleeding disorder- platelet count less than 50,000/microlitre, prothrombin time more than 14 sec, International normalized ratio (INR) more than 1.5  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Post spinal anaesthesia shivering  Outcome will be assessed during the intraoperative period. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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   Phase 3 
Date of First Enrollment (India)   22/08/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Post Spinal Anaesthesia Shivering (PSAS) is known to be a frequent complication and has reported incidence of 40-70%. Shivering is defined as the involuntary and oscillatory muscular activities that increase the metabolic rate by two to three folds to maintain the core temperature, with the increment of heat production. The study will be a Randomized controlled double blinded study to compare the efficacy of prophylactic Ondansetron and Dexmedetomidine in the prevention of post spinal shivering in patients undergoing elective lower abdominal surgeries under spinal anaesthesia.
A total number of 96 patients aged 18-60 years of either sex, ASA physical grade I and II who will be undergoing elective lower abdominal surgeries shall be enrolled in the study. The patients will be divided into three groups of 32 each. The study drug will be prepared in a 5 ml syringe by an anaesthesiologist not directly involved in the study to keep the study blinded. Group A will receive Normal saline, Group B will receive 0.1 mg/kg of intravenous Ondansetron and Group C will receive 1 mcg/kg of intravenous Dexmedetomidine. 0.5% of Inj. hyperbaric Bupivacaine will be used for spinal anaesthesia. The operating room temperature will be maintained at an ambient temperature of around 24 degree Celsius to 26 degree Celsius. Vital parameters like temperature, blood pressure, heart rate, SpO2 will be recorded preoperatively and intraoperatively. Time of onset of shivering along with its grade and the disappearance of shivering will be recorded. In case of failure to control shivering by study drugs 0.5 mg/kg of Inj. Tramadol will be used as rescue therapy.
The data collected will be analyzed and interpreted by appropriate statistical method. Quantitative data will be analyzed using Students t test and qualitative data will be analyzed using Chi square test. P value less than 0.05 will be taken as significant.
 
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