to Treat the Vomiting Frequently Occur Post-laparoscopic by Different Anti Emetic DrugsNCT04403191
Usage of Multiple Drugs in Treatment of Postoperative Vomiting After Laparoscopic Appendectomy
An observational study of to Treat the Vomiting Frequently Occur Post-laparoscopic by Different Anti Emetic Drugs, run by King Abdul Aziz Specialist Hospital at 1 site in Saudi Arabia.
Trial summary
To compare and evaluate the antiemetic effect and the safety of ondansetron, inhalational isopropyl alcohol and super hydration on adult patients after laparoscopic appendectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- to Treat the Vomiting Frequently Occur Post-laparoscopic by Different Anti Emetic Drugs
- What is being tested?
- Ondansetron, isopropyl alcohol 70% inhalation and laparoscopic appendectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 240 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Mar 2019to 10 Feb 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 240 patients admitted to surgical I.C.U of King Abdul-Aziz specialist hospital for post-operative care after laparoscopic appendectomy surgery between March 2019 till February 2020. A Koivuranta Score to Predict Postoperative Nausea and Vomiting done preoperatively for all the patients and only those who had score of more than 3 on Koivuranta vomiting score (had more than 60% chance to develop PONV) enrolled in our study. And randomly allocated in one of three groups group A, B or C.
Who may be able to join
- postoperative nausea and vomiting
Who cannot join
- systemic disease as diabetes or hypertension local gastric diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Ondansetron, Isopropyl Alcohol Inhalation and Super Hydration in Treatment of Postoperative Emesis After Laparoscopic Appendectomy
To compare and evaluate the antiemetic effect and the safety of ondansetron, inhalational isopropyl alcohol and super hydration on adult patients after laparoscopic appendectomy.
Read the detailed description
This prospective double-blind study done on 240 patients admitted to surgical I.C.U after laparoscopic appendectomy. Those who had preoperative Koivuranta vomiting score of more than 3 enrolled in our study. Every group contains 80 patients. Patients of group A received ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours while patients of group B received isopropyl alcohol 70% inhalation every 15 min for 4 times then repeated after 6 hours. The last group C received intravenous normal saline at rate of 20 ml/kg over 30 minute and repeated by the same dose after 6 hours. The duration of the study was 24 hours post-operatively. As PONV is self-limited within 24 hours.
- Being tested
- Ondansetron, isopropyl alcohol 70% inhalation, laparoscopic appendectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours while patients of group
isopropyl alcohol 70% inhalationDrug
inhalation every 15 min for 4 times then repeated after 6 hours
laparoscopic appendectomyProcedure or surgery
all patients received post operatively after laparoscopic appenectomy
| Study group | Role | What they receive |
|---|---|---|
| Group A | received ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours Receives: Drug: Ondansetron; Procedure: laparoscopic appendectomy | |
| Group B | received isopropyl alcohol 70% inhalation every 15 min for 4 times then repeated after 6 hours Receives: Drug: isopropyl alcohol 70% inhalation; Procedure: laparoscopic appendectomy | |
| Group C | received intravenous normal saline at rate of 20 ml/kg over 30 minute and repeated by the same dose after 6 hours. Receives: Procedure: laparoscopic appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
numbers of vomiting attacks
numbers of vomiting attacks recorded every 15 minutes for one day
Measured: for one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start10 Mar 2019
- Primary completion4 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for to Treat the Vomiting Frequently Occur Post-laparoscopic by Different Anti Emetic DrugsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- King Abdul Aziz Specialist Hospital
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403191
- Sponsor's protocol ID
- ICU-10-20
- Status last verified
- Mar 2020
- First submitted
- 20 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: To compare and evaluate the antiemetic effect and the safety of ondansetron, inhalational isopropyl alcohol and super hydration on adult patients after laparoscopic appendectomy.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Ondansetron, Isopropyl Alcohol Inhalation and Super Hydration in Treatment of Postoperative Emesis After Laparoscopic Appendectomy
- ClinicalTrials.gov ID
- NCT04403191
- Acronym / sponsor ID
- ICU-10-20
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- King Abdul Aziz Specialist HospitalResearch network
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare and evaluate the antiemetic effect and the safety of ondansetron, inhalational isopropyl alcohol and super hydration on adult patients after laparoscopic appendectomy.
Detailed description
This prospective double-blind study done on 240 patients admitted to surgical I.C.U after laparoscopic appendectomy. Those who had preoperative Koivuranta vomiting score of more than 3 enrolled in our study. Every group contains 80 patients. Patients of group A received ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours while patients of group B received isopropyl alcohol 70% inhalation every 15 min for 4 times then repeated after 6 hours. The last group C received intravenous normal saline at rate of 20 ml/kg over 30 minute and repeated by the same dose after 6 hours. The duration of the study was 24 hours post-operatively. As PONV is self-limited within 24 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: Ondansetron, Procedure: laparoscopic appendectomyreceived ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours |
| Group B | – | Drug: isopropyl alcohol 70% inhalation, Procedure: laparoscopic appendectomyreceived isopropyl alcohol 70% inhalation every 15 min for 4 times then repeated after 6 hours |
| Group C | – | Procedure: laparoscopic appendectomyreceived intravenous normal saline at rate of 20 ml/kg over 30 minute and repeated by the same dose after 6 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 240 patients admitted to surgical I.C.U of King Abdul-Aziz specialist hospital for post-operative care after laparoscopic appendectomy surgery between March 2019 till February 2020. A Koivuranta Score to Predict Postoperative Nausea and Vomiting done preoperatively for all the patients and only those who had score of more than 3 on Koivuranta vomiting score (had more than 60% chance to develop PONV) enrolled in our study. And randomly allocated in one of three groups group A, B or C.
Key inclusion criteria (1 listed)
- postoperative nausea and vomiting
Key exclusion criteria (1 listed)
- systemic disease as diabetes or hypertension local gastric diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ondansetronondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours while patients of group | Drug | Group A |
| isopropyl alcohol 70% inhalationinhalation every 15 min for 4 times then repeated after 6 hours | Drug | Group B |
| laparoscopic appendectomyall patients received post operatively after laparoscopic appenectomy | Procedure or surgery | Group A, Group B, Group C |
Primary outcome
numbers of vomiting attacks
Time frame: for one day
numbers of vomiting attacks recorded every 15 minutes for one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Individual participant dataSharing planned: No. To compare and evaluate the antiemetic effect and the safety of ondansetron, inhalational isopropyl alcohol and super hydration on adult patients after laparoscopic appendectomy.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of to Treat the Vomiting Frequently Occur Post-laparoscopic by Different Anti Emetic Drugs, run by King Abdul Aziz Specialist Hospital at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numbers of vomiting attacks (time frame: for one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.