Postoperative Nausea and VomitingNCT03459248
Metoclopramide-Ondansetron vs. Metoclopramide Therapy for Treatment of Nausea and Vomiting Post Laparoscopic Surgery
A study testing Dual therapy, Monotherapy and General anesthesia in people with Postoperative Nausea and Vomiting, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
The incidence of postoperative nausea and vomiting (PONV) after general anesthesia is up to 30% when inhalational anesthetics are used with no prophylaxis. This makes PONV one of the most common complaints following surgery under general anesthesia, together with postoperative pain. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Dual therapy, Monotherapy and General anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteLebanon
- Study dates
- 15 Feb 2018to 31 Jul 2019
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aging 16 years and above
- Patients undergoing laparoscopic cholecystectomy under General Anesthesia at Makassed General Hospital
Who cannot join
- Patients with history of motion sickness
- Patients on previous treatment by anti-emetics for dizziness, vertigo or other causes of nausea and vomiting
- Patients with any type of allergy to metoclopramide or ondansetron
- Patients refusing to be part of the study (refusal to sign consent)
- Patients on previous treatment by opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metoclopramide-Ondansetron Dual Therapy vs Metoclopramide Monotherapy for Treatment of Nausea and Vomiting Post Laparoscopic Cholecystectomy
The incidence of postoperative nausea and vomiting (PONV) after general anesthesia is up to 30% when inhalational anesthetics are used with no prophylaxis. This makes PONV one of the most common complaints following surgery under general anesthesia, together with postoperative pain.
Read the detailed description
This is a prospective, randomized, double-blind controlled clinical trial. Written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 equal groups:
Group 1: Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia.
Group 2: Patients will receive 10 mg metoclopramide before induction of general anesthesia.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Dual therapy, Monotherapy, General anesthesia
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual therapyOther
combination of 10 mg metoclopramide with 4 mg ondansetron
MonotherapyOther
10 mg metoclopramide
General anesthesiaOther
Induction of general anesthesia will be performed followed by endotracheal intubation.
| Study group | Role | What they receive |
|---|---|---|
| Dual therapy | Experimental | Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia Receives: Other: Dual therapy; Other: General anesthesia |
| Monotherapy | Active comparator | Patients will receive 10 mg metoclopramide before induction of general anesthesia. Receives: Other: Monotherapy; Other: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative nausea and vomiting
The Primary aim of this study is to compare the effect of prophylactic combination therapy (dual therapy) metoclopramide-ondansetron vs. ondansetron monotherapy for the treatment of postoperative nausea and vomiting after laparoscopic cholecystectomy. This will be assessed through a questionnaire with yes or no question where yes indicates the presence of nausea or vomiting and no indicating the absence of nausea or vomiting.
Measured: 36 hours postoperatively
Secondary outcomes (2)
Surgeon satisfaction
Assess surgeon satisfaction with anesthesia using a questionnaire named "the Surgeon Satisfaction with Anesthesia Services Scales". The questionnaire uses a scale: 1-strongly disagree, 2- disagree, 3- agree, 4- strongly agree
Measured: 36 hours postoperatively
Patient satisfaction
Assess patient satisfaction with anesthesia using the Iowa Satisfaction Anesthesia scale which measures patient satisfaction through a scale: strongly disagree, disagree, undecided, agree and strongly agree
Measured: 36 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start15 Feb 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zoher Naja, Makassed General Hospital
- Investigators
- Zoher Naja, MD, Principal investigator, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459248
- Sponsor's protocol ID
- 122018
- Status last verified
- Sep 2019
- First submitted
- 3 Mar 2018
- Last updated
- 27 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metoclopramide-Ondansetron Dual Therapy vs Metoclopramide Monotherapy for Treatment of Nausea and Vomiting Post Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03459248
- Acronym / sponsor ID
- 122018
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 8 Mar 2018 (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.
The incidence of postoperative nausea and vomiting (PONV) after general anesthesia is up to 30% when inhalational anesthetics are used with no prophylaxis. This makes PONV one of the most common complaints following surgery under general anesthesia, together with postoperative pain.
Detailed description
This is a prospective, randomized, double-blind controlled clinical trial. Written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 equal groups:
Group 1: Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia.
Group 2: Patients will receive 10 mg metoclopramide before induction of general anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual therapy | Experimental | Other: Dual therapy, Other: General anesthesiaPatients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia |
| Monotherapy | Active comparator | Other: Monotherapy, Other: General anesthesiaPatients will receive 10 mg metoclopramide before induction of general anesthesia. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aging 16 years and above
- Patients undergoing laparoscopic cholecystectomy under General Anesthesia at Makassed General Hospital
Key exclusion criteria (5 listed)
- Patients with history of motion sickness
- Patients on previous treatment by anti-emetics for dizziness, vertigo or other causes of nausea and vomiting
- Patients with any type of allergy to metoclopramide or ondansetron
- Patients refusing to be part of the study (refusal to sign consent)
- Patients on previous treatment by opioids
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 |
|---|---|---|
| Dual therapycombination of 10 mg metoclopramide with 4 mg ondansetron | Other | Dual therapy |
| Monotherapy10 mg metoclopramide | Other | Monotherapy |
| General anesthesiaInduction of general anesthesia will be performed followed by endotracheal intubation. | Other | Dual therapy, Monotherapy |
Primary outcome
postoperative nausea and vomiting
Time frame: 36 hours postoperatively
The Primary aim of this study is to compare the effect of prophylactic combination therapy (dual therapy) metoclopramide-ondansetron vs. ondansetron monotherapy for the treatment of postoperative nausea and vomiting after laparoscopic cholecystectomy. This will be assessed through a questionnaire with yes or no question where yes indicates the presence of nausea or vomiting and no indicating the absence of nausea or vomiting.
2 secondary outcomes
Surgeon satisfaction
Time frame: 36 hours postoperatively
Patient satisfaction
Time frame: 36 hours postoperatively
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 27 Sep 2019.
Related trials for Postoperative Nausea and Vomiting
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
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.
Zoher Naja, MD principal investigator
Makassed General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual therapy, Monotherapy and General anesthesia in people with Postoperative Nausea and Vomiting, run by Makassed General Hospital at 1 site in Lebanon.
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 2 inclusion and 5 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 27 Sep 2019. 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 Lebanon. 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?
postoperative nausea and vomiting (time frame: 36 hours postoperatively). 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 27 Sep 2019.