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CTRI Number  CTRI/2024/10/075204 [Registered on: 14/10/2024] Trial Registered Prospectively
Last Modified On: 03/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison of effects of dexamethasone and haloperidol Vs dexamethasone and amisulpride on postoperative nausea and vomiting in laproscopic cholecystectomy. 
Scientific Title of Study   Comparison of effects of dexamethasone and haloperidol Vs dexamethasone and amisulpride on postoperative nausea and vomiting in laproscopic cholecystectomy Randomised, controlled, 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 ARSHIYA GUPTA 
Designation  PG - 1ST YEAR RESIDENT 
Affiliation  School of Medical Sciences and Research 
Address  Department of Anaesthesiology, School of Medical Sciences and Research, plot no 32, 34, Knowledge park 3, Greater Noida, Gautam Buddha Nagar UTTAR PRADESH 201310 India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  7087424630  
Fax    
Email  arshiyagupta92@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR MAHENDERA KUMAR 
Designation  PROFESSOR 
Affiliation  School of Medical Sciences and Research 
Address  Department of Anaesthesiology, School of Medical Sciences and Research, plot no 32, 34, Knowledge park 3, Greater Noida, Gautam Buddha Nagar UTTAR PRADESH 201310 India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  8287188449  
Fax    
Email  mahendra.kumar@sharda.ac.in  
 
Details of Contact Person
Public Query
 
Name  DR MAHENDERA KUMAR 
Designation  PROFESSOR 
Affiliation  School of Medical Sciences and Research 
Address  Department of Anaesthesiology, School of Medical Sciences and Research, plot no 32, 34, Knowledge park 3, Greater Noida, Gautam Buddha Nagar UTTAR PRADESH 201310 India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  8287188449  
Fax    
Email  mahendra.kumar@sharda.ac.in  
 
Source of Monetary or Material Support  
SHARDA HOSPITAL 
 
Primary Sponsor  
Name  Sharda Hospital 
Address  Plot no.32,34,Knowledge park 3, Greater Noida, 201310 
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 Arshiya Gupta  sharda hospital, school of medical sciences and research  Department of Anaesthesiology, 2nd floor, b block Gautam Buddha Nagar UTTAR PRADESH Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH 
7087424630

arshiyagupta92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
School of medical sciences and research Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K808||Other cholelithiasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  i/v amisulpride  Patients of this group will receive Dexamethasone 8mg in 2ml and amisulpride 5 mg in 2 ml I/V just before induction of anesthesia. 
Intervention  i/v dexamethasone  Patients of this group will receive Dexamethasone 8mg in 2ml and Normal Saline 2 ml I/V just before induction of anesthesia. 
Comparator Agent  i/v haloperidol  Patients of this group will receive Dexamethasone 8mg in 2ml and haloperidol 1 mg in 2ml I/V just before induction of anesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients scheduled for elective laproscopic Cholecystectomy under General Anaesthesia.
2. ASA class 1 and 2.
3. Age 18-60 years.
4. Patients having at least two of following risk factors of PONV i.e ( Female gender , Non smoker , Prior history of PONV or motion sickness , being expected to receive opioid analgesia.) 
 
ExclusionCriteria 
Details  1.Patient receiving steroids, analgesics, antiemetic, sedatives and antipsychotics
2.Patient with past history of chronic pain.
3.Patient having history of endocrine, cardiovascular, renal or CNS disease
4.Patient having GI, Hepatic, renal disease.
5.Patient allergic to study drugs.
6.BMI more then 30.
 
 
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 dexamethasone and haloperidol vs dexamethasone and amisulpride in comparison of control group on the incidence of post operative nausea vomiting in patient of laproscopic cholecystectomy under GA.
 
24 Hrs.
 
 
Secondary Outcome  
Outcome  TimePoints 
a)To compare the PONV free period and requirement of rescue antiemetic in three groups
b)To compare the sedation score and pain score in three groups .
 
24 hrs. 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   20/10/2024 
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="1"
Months="6"
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  

Postoperative nausea and vomiting (PONV) is a common problem with reported rates ranging from 20% to 80%. It is second most common complication following surgery (first one is pain).

The etiology of PONV is complex, involving patient-related factors (such as sex, smoking status, and history of PONV), surgery-related factors (including the type of surgery), and anesthesia-related factors (such as the use of opioids and volatile anesthetics). In high-risk patients, PONV incidence can escalate to 80%. PONV if not treated may lead to complications like pulmonary aspiration, wound dehiscence, elevated intracranial pressure, and pneumothorax etc. It may also prolong post-anesthesia care unit stay time. Fourth consensus guidelines recommend antiemetic multidrug approach from different pharmacological classes.

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 opioids.

To control or prevent PONV, various drugs have been used like ondansetron, granisetron.

(5-HT3 antagonists), haloperidol (D2 antagonist) & dexamethasone(cortico steroid), anticholinergics and antihistamines as a single drug or a combination of multiple drugs with variable results and side effects. Multiple studies show that use of single drug as an antiemetic in the prophylaxis of PONV is less effective than the combination.

Dexamethasone 4-8mg IV has been used alone or in combination to reduce the incidence of PONV.

The D2 receptor is known for precipitating PONV, even in surgical patients. Therefore, there is a hypothesis that drugs with D2 receptor antagonist properties, can be utilized for prophylaxis in the treatment of PONV.

Haloperidol (D2 receptor antagonist) has been used in small doses (1-2mg IV) for prevention and treatment of PONV alone or with other antiemetic like dexamethasone.

Amisulpride, a potent and selective dopaminergic D2 and D3 receptor antagonist, has been approved recently for prevention and treatment of PONV in lower doses (5mg). Its use has also been recommended with a combination of other antiemetic of different class for better result.

Thus both drugs, Haloperidol and Amisulpride, have been employed alone or with other antiemetic of different class to prevent postoperative nausea and vomiting (PONV). But, no study is available for comparing haloperidol and amisulpride alone or in combination.

In the present study it will be assessed that out of these two drugs having same class whichone is better in terms of  control of PONV and side effects.

An extensive search of the literature did not reveal any study comparing the effects of these two drugs in combination with dexamethasone to control the incidence of PONV. Therefore, the present study will be conducted to compare the prophylactic effects of a combination of dexamethasone and haloperidol with dexamethasone and amisulpride on incidence of PONV in laparoscopic cholecystectomy.

 

 
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