| CTRI Number |
CTRI/2016/07/007108 [Registered on: 20/07/2016] Trial Registered Retrospectively |
| Last Modified On: |
02/05/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF INTRAVENOUS PALONOSETRON, DEXAMETHASONE AND THEIR COMBINATION AS ANTIEMETIC THERAPY IN LAPAROSCOPIC SURGERIES |
|
Scientific Title of Study
|
TO COMPARE THE EFFICACY OF INTRAVENOUS
PALONOSETRON, DEXAMETHASONE AND A
COMBINATION OF PALONOSETRON AND
DEXAMETHASONE AS PROPHYLACTIC ANTIEMETIC
THERAPY IN ADULT PATIENTS UNDERGOING
LAPAROSCOPIC SURGERIES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Sadhoo |
| Designation |
Senior Resident |
| Affiliation |
Guru Gobind Singh Indraprastha University |
| Address |
Department of Anaesthesiology Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9560509710 |
| Fax |
|
| Email |
nehasadhoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Sadhoo |
| Designation |
Senior Resident |
| Affiliation |
Guru Gobind Singh Indraprastha University |
| Address |
Department of Anaesthesiology Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9560509710 |
| Fax |
|
| Email |
nehasadhoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavan Gurha |
| Designation |
HoD Department of Anaesthesia and Critical Care |
| Affiliation |
Batra Hospital and Medical Research Centre |
| Address |
Batra Hospital and Medical Research Centre,1, Mehrauli Badarpur Road, Tughlakabad, Delhi - 110044, Tuglakabad Institutional Area
South
DELHI
110044
India |
| Phone |
9811088632 |
| Fax |
|
| Email |
pavan_gurha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Batra Hospital and Medical Research Centre, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Neha Sadhoo |
| Address |
Department of Anaesthesia, Safdarjung Hospital, New Delhi |
| Type of Sponsor |
Other [] |
|
|
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 Neha Sadhoo |
Batra Hospital and Medical Research Centre |
OT Complex, First Floor, New Building, Batra Hospital and Medical Research Centre, 1, Mehrauli Badarpur Road, Tughlakabad, Delhi - 110044, Tuglakabad Institutional Area
South
DELHI |
9560509710
nehasadhoo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific and Ethical committee, Batra Hospital and Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Adult ASA Grade I or II patients of either sex, aged 18 to 60 years, who underwent elective laparoscopic surgeries under
general anaesthesia. , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous injection |
Group P : Received Palonosetron 0.075 mg i.v
Group D : Received Dexamethasone 8 mg i.v, diluted in normal saline
Group P + D : Received Palonosetron 0.075 mg and
Dexamethasone 8 mg i.v, diluted in normal saline. Drug solutions were prepared by a person not involved in the study. |
| Comparator Agent |
Palonosetron 0.075 mg and Dexamethasone 8 mg |
Group P : Received Palonosetron 0.075 mg i.v
Group D : Received Dexamethasone 8 mg i.v, diluted in normal saline
Group P + D : Received Palonosetron 0.075 mg and
Dexamethasone 8 mg i.v, diluted in normal saline. Drug solutions were prepared by a person not involved in the study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult ASA Grade I or II patients, who underwent elective laparoscopic surgeries under
general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating females
2. Patients older than 60 years or younger than 18 years of age
3. Patients with a history of central nervous system or neuromuscular disease
4. Patients with ASA physical status grade > II
5. Morbidly obese patients
6. Patients with hepatic, renal or cardio-respiratory disease
7. Patients with gastro-esophageal reflux
8. Patients with history of drug or alcohol abuse
9. Patients with known hypersensitivity to either Palonosetron or Dexamethasone
10. Patients with previous history of PONV or motion sickness
11. Patients receiving chemotherapy or radiotherapy |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Incidence of PONV- using a 3- point scale ( 0-none, 1-nausea, 2-
vomiting ).
2. Number of patients needing rescue antiemetic treatment.
3. Pain intensity scores- obtained with VAS test. |
0, l, 2, 4, 8 and
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Heart rate
2. Blood pressure
3. Respiratory rate
4. Incidence of nausea and vomiting
5. Visual analogue scale score |
0, l, 2, 4, 8 and
24 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
28/11/2011 |
| 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) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study endeavoured to compare the efficacy of the combination of Palonosetron and Dexamethasone with that of either drug alone in prevention of postoperative nausea and vomiting in patients undergoing laparoscopic surgeries. In conclusion, the results of the present study indicate that: 1. The incidence of postoperative nausea and vomiting after laparoscopic surgeries is very high. 2. Both prophylactic intravenous palonosetron (0.075 mg) and dexamethasone (8 mg) are safe and effective in reducing the incidence of postoperative nausea and vomiting for 24 hours after surgery. 3. The combination therapy of palonosetron plus dexamethasone did not significantly reduce the incidence of postoperative nausea and vomiting (PONV) when compared with either drug alone. 101 4. The combination therapy with intravenous palonosetron and dexamethasone should only be reserved for patients who are at extremely high risk of developing PONV after laparoscopic surgeries. 5. There is a current need for a definitive study to further examine the role of combination therapy of palonosetron and dexamethasone in preventing postoperative nausea and vomiting after laparoscopic surgeries as the real benefit to patients will only be realized if these combinations make PONV a rare occurrence. |