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CTRI Number  CTRI/2024/08/073057 [Registered on: 28/08/2024] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the efficacy of ondasetron vs palonosetron in prevention of shivering under spinal anaesthesia in patients undergoing TURP. 
Scientific Title of Study   Comparing the efficacy of Ondansetron vs palonosetron in prevention of shivering under spinal anesthesia in patients undergoing transurethral resection of the prostate 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Renganathan Sockalingam 
Designation  Associate professor 
Affiliation  Velammal Hospital and Medical College 
Address  Room number 2,Department of Anaesthesia,near MOT Complex,Velammal medical college,velammal Village, Madurai - Tuticorin, ring Road, Anuppanadi, Tamil Nadu 625009

Madurai
TAMIL NADU
625009
India 
Phone  9500025879  
Fax    
Email  renganathansockalingam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Indumathy S 
Designation  Associate professor 
Affiliation  Velammal Hospital and Medical College 
Address  Room number 2,Department of Anaesthesia,near MOT Complex,Velammal medical college,velammal Village, Madurai - Tuticorin, ring Road, Anuppanadi, Tamil Nadu 625009

Madurai
TAMIL NADU
625009
India 
Phone  9677589605  
Fax    
Email  aarathana.apple@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Renganathan Sockalingam 
Designation  Associate professor 
Affiliation  Velammal Hospital and Medical College 
Address  Room number 2,Department of Anaesthesia,near MOT Complex,Velammal medical college,velammal Village, Madurai - Tuticorin, ring Road, Anuppanadi, Tamil Nadu 625009

Madurai
TAMIL NADU
625009
India 
Phone  9500025879  
Fax    
Email  renganathansockalingam@gmail.com  
 
Source of Monetary or Material Support  
Velammal Medical College and hospital, Room number 2, Department of Anaesthesia, near MOT Complex, Velammal medical college,velammal Village, Madurai - Tuticorin, ring Road, Anuppanadi, Tamil Nadu 625009 
 
Primary Sponsor  
Name  velammal medical college and hospital 
Address  Velammal Village, Madurai - Tuticorin, Airport-Mattuthavani Ring Rd, Chinthamani, Tamil Nadu 625009 
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 S Renganathan  Velammal Medical college and hospital  Room number 2,Department of Anaesthesia,near MOT Complex,Velammal medical college,velammal Village, Madurai - Tuticorin, ring Road, Anuppanadi, Tamil Nadu 625009
Madurai
TAMIL NADU 
9500025879

renganathansockalingam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
velammal medical college and research institute  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 
Intervention  Palonosetron Group   Upon arrival in the OR, patients received 0.075 mg of palonosetron intravenously, 30 minutes before the spinal anesthesia, as per their assigned group. Both drugs were prepared in 4 ml volume within 5 ml syringes, and the OR staff responsible for drug preparation remained unaware of the study details. Subarachnoid block was initiated using 2.8 ml of 0.5% bupivacaine (heavy) with a 25/26G Quincke needle. Monitoring adhered to ASA standards, encompassing SpO2, electrocardiography (ECG), and non‐invasive blood pressure (NIBP) assessments. Sublingual temperature readings were taken prior to surgery commencement and subsequently recorded at 30-minute intervals for the next 120 minutes.  
Comparator Agent  Ondasetron Group   Upon arrival in the OR, patients received 8 mg of ondansetron intravenously, 30 minutes before the spinal anesthesia, as per their assigned group. Both drugs were prepared in 4 ml volume within 5 ml syringes, and the OR staff responsible for drug preparation remained unaware of the study details. Subarachnoid block was initiated using 2.8 ml of 0.5% bupivacaine (heavy) with a 25/26G Quincke needle, ensuring the adequacy of the block. The monitoring adhered to ASA standards, encompassing SpO2, electrocardiography (ECG), and non‐invasive blood pressure (NIBP) assessments. Sublingual temperature readings were taken before surgery commencement and subsequently recorded at 30-minute intervals for the next 120 minutes.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  Age 40–80 years,
ASA grading I, II
Patients undergoing elective TURP procedures
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Temperature
2. Shivering-UL/LL
 
1. Sublingual temperature readings were taken before surgery commencement and subsequently recorded at 30-minute intervals for the next 120 minutes.
2. The shivering grading system followed was adapted from the study conducted by Wrench et al. Patients were observed intraoperatively and for 120 minutes postoperatively.  
 
Secondary Outcome  
Outcome  TimePoints 
pulse rate
blood pressure
oxygen saturation 
it is measured every 30 minutes intraoperatively up to 120 minutes perioperatively 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2024 
Date of Study Completion (India) 01/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
indian journal of clinical Anesthesia 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Shivering, an involuntary skeletal muscle activity, commonly triggered by hypothermia, poses challenges in the perioperative period, affecting postoperative recovery. Pharmacological interventions, including opioids and 5-HT3 receptor antagonists, aim to alleviate shivering. Ondansetron, a first-gen antiemetic, has demonstrated efficacy in preventing shivering in diverse surgeries. Palonosetron, a newer 5-HT3 antagonist with an extended half-life and higher receptor affinity, holds promise but lacks conclusive evidence. While Ondansetron’s effectiveness is supported by studies in cesarean section and hernia repair, direct comparisons with Palonosetron are limited. Insights from studies on serotonin receptor antagonists, like ramosetron, offer relevant information. Considering the context of Transurethral Resection of the Prostate (TURP), understanding its complications, management, and procedural outcomes is crucial. Although literature predominantly features Ondansetron, a gap exists in direct comparisons between Ondansetron and Palonosetron in preventing shivering during TURP under spinal anesthesia. Further research specific to TURP patients is essential for conclusive evidence on the comparative efficacy of these medications. Hence this study aimed to compare the efficacy of ondansetron and palonosetron in preventing Post-Anesthesia Shivering (PAS) in patients undergoing TURP procedures under spinal anesthesia. Shivering, characterized as an involuntary and repetitive activity of skeletal muscles, is primarily triggered by hypothermia but has also been documented in normothermic patients. The etiological mechanisms involve hypothesized pathways mediated by uninhibited spinal reflexes, postoperative pain, and hyperactive sympathetic activities. Variations in the frequency and patterns of shivering are observed across different anesthesia modalities. 

 


 
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