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CTRI Number  CTRI/2024/05/068021 [Registered on: 29/05/2024] Trial Registered Prospectively
Last Modified On: 29/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of combined paracetamol and dexamathasone on post operative nausea and vomiting in patients undergoing elective functional endoscopic sinus surgery. 
Scientific Title of Study   A prospective randomized double blinded study - Effect of combined paracetamol and dexamethasone on post operative nausea and vomiting. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  LAKSHMI PRIYA R  
Designation  Post Graduate  
Affiliation  Sri Ramachandra Institute of Higher Education and Research, Porur 
Address  The Department of Anaesthesiology, Critical care and Pain Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur

Chennai
TAMIL NADU
600116
India 
Phone  8072574147  
Fax    
Email  m2321009@sriher.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Arul Murugan  
Designation  Associate Professor M.D. Anaesthesiology 
Affiliation  Sri Ramachandra Institute of Higher Education and Research, Porur 
Address  The Department of Anaesthesiology, Critical care and Pain Medicine Sri Ramachandra Institute of Higher Education and Research, Porur

Chennai
TAMIL NADU
600116
India 
Phone  8072574147  
Fax    
Email  rampond@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arul Murugan 
Designation  Associate Professor M.D. Anaesthesiology 
Affiliation  Sri Ramachandra Institute of Higher Education and Research, Porur 
Address  The Department of Anaesthesiology, Critical care and Pain Medicine Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai Chennai TAMIL NADU

Chennai
TAMIL NADU
600116
India 
Phone  8072574147  
Fax    
Email  rampond@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116, Tamil Nadu, India 
 
Primary Sponsor  
Name  Lakshmi Priya R  
Address  The Department of Anaesthesiology, Critical care and Pain Medicine Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 
Type of Sponsor  Other [Self financing] 
 
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 
Lakshmi Priya R   Sri Ramachandra Institute of Higher Education and Research   The Department of Anaesthesiology, Critical care and Pain Medicine Sri Ramachandra Institute of Higher Education and Research, Porur
Chennai
TAMIL NADU 
8072574147

m2321009@sriher.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H958||Other intraoperative and postprocedural complications and disorders of the ear and mastoid process, not elsewhere classified, (2) ICD-10 Condition: H578||Other specified disorders of eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  paracetamol with dexamethasone  paracetamol 30ml/kg is given intravenously along with dexamethasone 0.1mg/kg intravenously before induction once. The duration of the intervention is observation for 12 hours post operatively. 
Comparator Agent  placebo with dexamethasone  normal saline 100ml is given along with dexamethasone 0.1mg/kg intravenously before induction once. The duration of the intervention is observation for 12 hours post operatively.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA 1 to 2
2. All Elective FESS surgery
3. All procedures done under General anaesthesia with a duration of less than 3 hours
4. Willingness to participate in the study
 
 
ExclusionCriteria 
Details  1. Patient’s refusal to give consent
2. Allergy to paracetamol, ondansetron
3. Emergency cases
4. ASA 3 and above
5. Patients requiring admission to the intensive care unit or
mechanical ventilation
6. Surgery duration more than 3 hours
7. Patients with history of gastroesophageal reflux disorder, peptic
ulcer disease, inflammatory bowel disease.
8. Patients with history of PONV, systemic diseases with nausea and
vomiting
9. Patients requiring opioids in the post operative period 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
incidence of post operative nausea and vomiting   1) incidence of nausea and vomiting is assessed from 1 minute
after induction till the entire surgery and 12 hours
post operatively
2) severity of nausea and vomiting is assessed from 1 minute
after induction till the entire surgery and 12 hours
post operatively
3) need for rescue antiemetics is assessed from 1
minute after induction till the entire surgery and
12 hours post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
incidence of post operative pain  1) incidence of pain is assessed from 1 minute
after induction till the entire surgery and 12 hours
post operatively
2) severity of pain is assessed from 1 minute
after induction till the entire surgery and 12 hours
post operatively
3) need for rescue analgesics is assessed from 1
minute after induction till the entire surgery and
12 hours post operatively 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 4 
Date of First Enrollment (India)   09/06/2024 
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="0"
Months="6"
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 operative nausea and vomiting (PONV) is one of the most
common distressed, with incidence ranging from 12-38%. The
pathophysiology of PONV is multifactorial; multiple pathways,
neurotransmitters, and risk factors are involved. Some of the
contributing factors for PONV include age < 50 years, female
gender, history of previous PONV or motion sickness,
nonsmoking, obesity, surgical- and anesthetic-related factors
like gastric inflation during mask ventilation, use of opioids and
nitrous oxide and/or parental anxiety.
The feelings associated with PONV are unpleasant and
distressful requiring multimodal treatment approaches. Recent
evidence indicated that inadequate prevention or treatment of
PONV potentiates prolonged recovery and hospitalization,
unpleasant hospital experiences, and increased health care
costs. For instance, prolonged vomiting may result in electrolyte
imbalance (hypocalcemia, hypochloremia, and hyponatremic
metabolic alkalosis) and dehydration, Mallory-Weis tears,
esophageal rupture, aspiration, wound dehiscence, increased
intracranial pressure, postoperative bleeding, and airway
obstruction especially in patients undergoing ENT surgery.
The use of antiemetics can reduce the occurrence of PONV
from over 52% to less than 30% in certain populations. To
decrease the incidence of PONV, a number of antiemetics
including antihistamines, butyrophenones, serotonin receptor
antagonists, corticosteroids, and anesthetic agents have been
tried in clinical use. Nevertheless, most of the antiemetics are
associated with undesirable adverse effects, such as sedation,
hypotension, dysphoria, dry mouth, restlessness, and
extrapyramidal symptoms.
Several studies have shown that dexamethasone, a
corticosteroid, is an effective antiemetic for PONV prophylaxis in
various types of surgery and in improving surgical outcomes.
Dexamethasone is an economical and efficacious antiemetic
drug with negligible side effects. Paracetamol is an analgesic or
anti-pyretic which can inhibit the activity of the cyclooxygenase
enzyme, which leads to inhibition of the prostaglandin production, equivalent to the NSAID. 
The Primary objective of this study is to prove whether the
combination of paracetamol and dexamethasone is better
dexamethasone alone in preventing PONV. It is to find out if
paracetamol has any role in reducing PONV and can add to the
efficacy of dexamethasone in further reducing PONV.
 
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