| 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
|
|
|
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
|
|
|
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 nonâ€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 nonâ€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 |
|
|
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.
|