| 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
|
|
|
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
|
|
|
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. |