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CTRI Number  CTRI/2025/08/093603 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 23/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of effects of Amisulpride and Dexamethasone vs Ondansetron and Dexamethasone on post-operative nausea and vomiting in patients of middle ear surgery- A randomised, double blinded study 
Scientific Title of Study   Comparison of effects of Amisulpride and Dexamethasone vs Ondansetron and Dexamethasone on post-operative nausea and vomiting in patients of middle ear surgery- A randomised, double blinded study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shefali 
Designation  Post Graduate 
Affiliation  School of medical sciences and research 
Address  Department of Anaesthesiology School of medical sciences and research Sharda university, Greater Noida Gautum Budh Nagar
Department of Anaesthesiology School of medical sciences and research Sharda university, Greater Noida Gautum Budh Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  8196966313  
Fax    
Email  shefail997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mahendra Kumar 
Designation  Professor 
Affiliation  Sharda University 
Address  Department of Anaesthesiology School of medical sciences and research Sharda university, Greater Noida Gautum Budh Nagar

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  8287188449  
Fax    
Email  mahendra.kumar@sharda.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Mahendra kumar 
Designation  Professor 
Affiliation  School of medical sciences and research 
Address  Department of Anaesthesiology School of medical sciences and research Sharda university, Greater Noida Gautum Budh Nagar
Department of Anaesthesiology School of medical sciences and research Sharda university, Greater Noida Gautum Budh Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  8287188449  
Fax    
Email  mahendra.kumar@sharda.ac.in  
 
Source of Monetary or Material Support  
Sharda Hospital,sharda university 
 
Primary Sponsor  
Name  Sharda Hospital 
Address  plot no 32,34, knowledge park 3 greater noida 
Type of Sponsor  Private medical college 
 
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 Shefali  Sharda Hospital  Department of Anaesthesiology School of medical sciences and research Sharda university, Greater Noida Gautum Budh Nagar Department of Anaesthesiology School of medical sciences and research Sharda university, Greater Noida Gautum Budh Nagar
Gautam Buddha Nagar
UTTAR PRADESH 
08196966313

shefail997@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  
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  Amisulpride + Dexamethasone  Patients of this group will receive injection Dexamethasone 8mg (2 ml) and Amisulpride 5 mg (2 ml) I/V just before the induction of anesthesia, and normal saline 2 ml I/V 30 minutes before extubation. 
Comparator Agent  Ondasetron + Ondasetron  Patients of this group will receive Dexamethasone 8mg (2 ml) and normal saline 2 ml I/V just before the induction of anesthesia, and injection Ondansetron 4 mg (2 ml) I/V 30 minutes before extubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients scheduled for middle ear surgery under general anaesthesia.
2. Patients aged 18-60 years
3. ASA Class I and II.
4. Both genders
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effects of amisulpride and dexamethasone vs ondansetron and dexamethasone on incidence of post-operative nausea and vomiting in patients of middle ear surgery.  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare PONV free period and requirement of rescue antiemetic in two groups during postoperative 24 hrs.
2. To compare the degree of post-operative sedation at various intervals in two groups. 
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)   12/09/2025 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The term postoperative nausea and vomiting (PONV) is typically used to describe nausea and/or vomiting or retching in the first 24 h postoperatively. As a patient-specific concern, it has been reported to increase patient dissatisfaction and postoperative pain thus prolonging the stay in hospital. The overall incidence of Postoperative nausea and vomiting (PONV) is about 25-30% after general anesthesia and surgery.1 In particular, middle ear surgery under general anaesthesia is associated with a high incidence of PONV, accounting for 62-80%.2

Risk factors which contribute to increasing the incidence of postoperative nausea and vomiting, are younger age group (<50 years), female patients, history of motion sickness and postoperative nausea and vomiting, non-smokers and use of opioids3.

PONV, if not treated, may cause dehydration electrolyte imbalance as well as other complications such as incisional pain, wound dehiscence, aspiration pneumonitis, increased intracranial pressure.4

Various drugs have been used to prevent and treat the PONV like dexamethasone, metoclopramide, ondansetron, droperidol, granisetron etc, but none of them provide complete relief to all patients. A significant number of patients develop PONV even after getting the preventive drugs.5  

Middle ear surgery may disturb the vestibular system, and opioids increase vestibular sensitivity. Vestibular stimulation increases the incidence of nausea and vomiting caused by opioids. Ondansetron is said to have a significant antiemetic effect on patients suffering from opioid-induced emesis. The site of inhibitory action of ondansetron on PONV after middle ear surgery might be the nucleus tractus solitarius which has a high concentration of 5-HT3 receptors. The prophylactic use of ondansetron on PONV in middle ear surgery has been studied previously with reduction in incidence of PONV as compared to control group.6

Recently, an injectable form of amisulpride (low single dose 5 mg IV) was shown to be effective at preventing PONV. This low dose neither show toxicity as compared to placebo and nor prolonged the QT interval enough to be clinically relevant in a randomized, double-blinded, placebo-controlled, multi-centered study.7

Dexamethasone for the prevention of PONV has been used 5–10 mg intravenously in adults. It is effective in preventing a late onset of PONV, as the onset of the effect of dexamethasone usually takes much longer time. For this reason, dexamethasone is not considered as an effective drug for immediate relief of existing PONV. So, a combination of dexamethasone and serotonin antagonist (ondansetron) may be the most effective treatment for preventing PONV. 8

It has been seen that a combination of dexamethasone and ondansetron is more effective in reducing PONV in middle ear surgery as compared to individual drug therapy.9

The fourth consensus guidelines for the management of post-operative nausea and vomiting (PONV) recommends a combination of two or more drugs acting through different mechanisms for the prophylaxis of PONV, as the etiology of PONV is complex and multi-factorial10.

No study was found in literature showing comparison of effects of amisulpride and dexamethasone vs ondansetron and dexamethasone on PONV.

Therefore, in the present study, effects of amisulpride and dexamethasone will be compared with the effects ondansetron and dexamethasone on incidence of PONV in the patients of middle ear surgery.

 
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