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CTRI Number  CTRI/2024/07/070858 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 18/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   To observe the effects of intravenous drug amisulpride for the avoidance of postoperative nausea and vomiting after general anaesthesia. 
Scientific Title of Study   To observe the efficacy of intravenous amisulpride for the prevention of postoperative nausea and vomiting in patients undergoing surgeries under general anaesthesia. 
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 Birva Khara 
Designation  Professor 
Affiliation  Pramukhswami Medical College,Shree Krishna Hospital, Bhaikaka University 
Address  Department of Anaesthesiology, 1st floor H.M patel academic center,Pramukhswami Medical College,Shree Krishna Hospital,karamsad, Anand, Gujarat, India

Anand
GUJARAT
388325
India 
Phone  9537122077  
Fax    
Email  Birvank@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mayur Limbachiya 
Designation  Resident Doctor, Department of Anaesthesiology 
Affiliation  Pramukhswami Medical College,Shree Krishna Hospital, Bhaikaka University 
Address  Department of Anaesthesiology, Pramukhswami Medical College, Shree Krishna Hospital, Karamsad

Anand
GUJARAT
388325
India 
Phone  9099242212  
Fax    
Email  mayurbapa@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mayur Limbachiya 
Designation  Resident Doctor, Department of Anaesthesiology 
Affiliation  Pramukhswami Medical College,Shree Krishna Hospital, Bhaikaka University 
Address  Department of Anaesthesiology, Pramukhswami Medical College, Shree Krishna Hospital, Karamsad

Anand
GUJARAT
388325
India 
Phone  9099242212  
Fax    
Email  mayurbapa@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, Pramukhswami Medical College,Gokulnagar,karamsad,Dist- Anand,Gujarat,India.Pin -388325 
 
Primary Sponsor  
Name  Shree Krishna Hospital  
Address  Karamsad, Anand , Gujarat,India,Pin 388325 
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 Mayur limbachiya  Shree krishna Hospital, Pramukhswami Medical College   Department of Anaesthesiology, Pramukhswami Medical College, Karamsad
Anand
GUJARAT 
9099242212

mayurbapa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaikaka University,Karamsad,Anand,Gujarat-388325  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, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients scheduled for surgery under general anaesthesia
2.Patients who are able to provide informed and written consent.
3.Patients with ASA status I,II,III 
 
ExclusionCriteria 
Details  1.Refusal to give written and informed consent.
2.Haemodynamically unstable (patients in shock or on vasopressor support).
3.Patients expected to require post-operative ventilation or need a nasogastric tube or oro-gastric tube in situ after surgery.
4.Patients with Parkinson disease or a preexisting vestibular disorder or history of dizziness, a history of alcohol abuse, a clinical significant cardiac arrhythmia or epilepsy.
5.History of drug allergy/allergy to study drugs.
6.On steroid therapy, opioid therapy or medications causing nausea/vomiting
7.Pregnant and lactating patients.
8.Patients who received antiemetic drugs within 24 h before anesthesia.
9.Patients with congenital long QT syndrome 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To observe the incidence of post operative nausea and vomiting in patients undergoing elective or emergency surgery under general anaesthesia  Post operative period 0-24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess Time of incidence of post operative nausea and vomiting from the administration of amisulpride.
2.To assess Frequency of rescue antiemetic(ondansetron) given after the occurrence of PONV in the 24 hours period postoperatively
3.Type of rescue analgesics given in the first 24 hours postoperative period.
 
Post operative period 0-24 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   29/07/2024 
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="0"
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  

    After obtaining institutional ethics committee approval and written and informed consent from patients of ASA I, II or III who will be undergoing  surgery under general anaesthesia will be included in this study. Preanaesthetic check-up will be carried out in all patients.

        Patients will be kept Nil by mouth(NBM) for 8 hours for solids and 2 hrs for clear liquid  before surgery.Appropriate fluids will be started in preoperative room and will be continued in the operation theatre (OT). After the patient is taken in the operating room, monitors like Pulse oximetry, electrocardiogram, non invasive blood pressure monitoring, manual blood pressure monitoring and end tidal carbon dioxide monitoring device will be applied and hemodynamic variables will be measured on arrival to the OT and every 5 min thereafter till the end of surgery.

       Standard anesthesia technique  for induction of general anesthesia will be used. Patients will be premedicated with injection midazolam, fentanyl, xylocard as per protocol and  intravenous amisulpride 5 mg will be given. Patients will be induced with propofol and with or without  muscle relaxation as per the case.  General anaesthesia will be given by Endotracheal Tube/ IGEL/ LMA. Anesthesia will be maintained by O2,AIR and Sevoflurane/ Desflurane. End-tidal CO2 will be maintained between 35 and 40 mm of Hg. Pulse rate, electrocardiogram, NIBP, and oxygen saturation will be  monitored continuously throughout the procedure. At the end of procedure if the patient will be given non depolarizing muscle relaxant neuromuscular blockade will be reversed with Inj.neostigmine and Inj.glycopyrolate. Before  extubation as per the standard protocol Inj paracetamol 1gm(100ml)will be given.After extubation, patients will be shifted to recovery room for further observation.Post operative period will be defined from the closure of wound till 24 hours.

       In the post-operative period, incidence of nausea, vomiting will be assessed by direct questioning  the patient at 0.5, 1, 2,  6, 12, 24 hours after surgery.Severity of nausea will be assessed using a 11 point verbal rating scale(VRS), with 0 representing no nausea at all and 10 the worst nausea imaginable and “significant nausea” will be defined as any score of 4 and over.

      The incidence of PONV will be defined as the occurrence of nausea and vomiting in the 24 hour period after the end of the surgery and time of the incidence of PONV from the administration of amisulpride will be noted.If it occurs, then rescue antiemetic ondansetron 4 mg intravenous will be given and  total frequency of rescue anti-emetic doses given in the 24 hour postoperative period  will be observed with time.

       Type of rescue analgesic given in the first 24 hours will be noted.

 
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