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