| CTRI Number |
CTRI/2018/01/011345 [Registered on: 15/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between two antiemetics (ondansetron and ramosetron) in the prevention of Post operative nausea and vomiting |
|
Scientific Title of Study
|
Comparison of ramosetron and ondansetronf for prevention of early and delayed Post operative nausea and vomiting following craniotomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Obaid Ahmad Siddiqui |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College,AMU |
| Address |
Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College,AMU,Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897695761 |
| Fax |
|
| Email |
obaidahmad2008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Obaid Ahmad Siddiqui |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College,AMU |
| Address |
Department Of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College,AMU,Aligarh,Uttar Pradesh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897695761 |
| Fax |
|
| Email |
obaidahmad2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Obaid Ahmad Siddiqui |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College,AMU |
| Address |
Department of Anaesthesiology and Critical Care,AMU,Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897695761 |
| Fax |
|
| Email |
obaidahmad2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College,Aligarh Muslim University |
|
|
Primary Sponsor
|
| Name |
Obaid Ahmad Siddiqui |
| Address |
Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College,Aligarh Muslim University |
| Type of Sponsor |
Government 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 |
| HASSAN |
Jawaharlal Nehru Medical College,Aligarh Muslim University |
Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College,Aligarh Muslim University
Aligarh
UTTAR PRADESH |
9997792731
Hassandoc90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethical Committee,Faculty of Medicine,Aligarh Muslim University,Aligarh,Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, The patients undergoing Craniotomy(Intra-cranial neoplasm, Traumatic brain Injury)were assessed for Post-Operative Nausea and Vomiting for 48 Hours, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Ondansetron |
The efficacy and side effects of Injection Ramosetron were compared with that of Injection Ondansetron in the prevention of post-operative nausea and vomiting in the patients undergoing Craniotomy. |
| Intervention |
Injection Ramosetron |
The efficacy and side effects of Injection Ramosetron for the prevention of post-operative nausea and vomiting was assessed for 48 hours postoperatively for patients undergoing craniotomy |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA I & II patients.
2.Mallampatti grades I & II. |
|
| ExclusionCriteria |
| Details |
1.Patients with a history of motion sickness, Gastroesophageal Reflux Disease (GERD).
2.Patients with major Cardiovascular Disease, Respiratory Disease and uncontrolled diabetes mellitus.
3.Patients with anticipated difficult intubation.
4.History of alcohol, drug abuse or smokers.
5.Post operative Glasgow Coma Score (GCS) less than 8.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
- POST OPERATIVE NAUSEA AND VOMITING.
|
-NAUSEA VOMITING RETCHING |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SIDE EFFECTS OF DRUGS USED |
Dizziness
Headache
Dyspepsia
Weakness
Flushing
Urticaria
|
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "130"
Final Enrollment numbers achieved (India)="130" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
04/01/2016 |
| Date of Study Completion (India) |
11/01/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We
conducted a prospective,
randomized, double-blinded study to compare the efficacy of Ondansetron with
Ramosetron in preventing early (0-24 hours) and delayed (24-48 hours)
post-operative nausea and vomiting (PONV) in 130 patients undergoing craniotomy
under general anaesthesia.
The study was conducted after obtaining
institutional ethical committee clearance and written informed consent from all
patients. Thorough pre-anaesthetic evaluation was done, investigations were
noted.
Patients were randomized into two groups,
ondansetron group (control group) and ramosetron group (study group) of 65
patients each using a computer generated randomization table.
Patients in both the groups were administered
general anaesthesia using the same anaesthetic protocol. Patients in control
group were given Injection ondansetron 4mg IV while patients in study group
received injection ramosetron 0.3 mg IV 30 minutes before closure of skin.
In the post-operative period, patients were monitored for nausea,
vomiting, pain and vital signs. Patients were closely monitored for 48 h and
any complaint of nausea, retching, and vomiting or adverse drug effect was
recorded by an independent observer (usually a Resident Doctor) who was blinded
to the study. Inj. Metoclopramide (0.15 mg/kg I.V.) was administered as an
additional rescue antiemetic in patients with two or more than two episodes of
vomiting and/or significant nausea at any time within 48 hours of operation.
Exact timing of the administration of the rescue antiemetic was recorded.
Patients in both the groups were
found to be comparable in terms of age, height, weight, ASA status, nature of
surgery (tumour/vascular), pre-operative heart rate and mean arterial pressure
(MAP) with no statistical significance.
Also, all the patients underwent craniotomies
and the mean duration of anaesthesia and the mean duration of surgery were also
comparable with no statistical significance.
The incidence and severity of
delayed vomiting and retching were significantly lesser in Ramosetron group as
compared to Ondansetron group.
So
from our study we derive that Ramosetron is better than ondansetron at
preventing delayed PONV (24-48 Hours) after craniotomy under general
anaesthesia. However, both the drugs are comparable in preventing early PONV
(0-24 Hours). The incidence of side effects is similar in Ondansetron and
Ramosetron.
|