| 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
|
|
|
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
|
|
|
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 |
|
|
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. |