Postoperative Nausea and VomitingPhase 3NCT06288035
Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
A Phase 3 study testing Dexamethasone Oral and Dexamethasone in people with Postoperative Nausea and Vomiting, run by Mansoura University at 1 site in Egypt.
Trial summary
Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone at night before surgery in preventing PONV after elective laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Dexamethasone Oral and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 814 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Mar 2024to Mar 2025
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all consecutive adults (older than 18 years) with ASA physical status I-III undergoing elective laparoscopic cholecystectomy surgery.
Who cannot join
- steroids or antiemetics within 1 week of surgery
- chronic opioid therapy
- history of allergy to any of the study drug
- serum creatinine > 1.4 mg/dl
- liver enzymes > triple the normal limits
- pregnancy
Show all 9Show fewer
- patient refusal
- and psychiatric or neurologic diseases or socioeconomic status that would hinder the postoperative quality of recovery questionnaire
- laparoscopic surgery is converted to open surgery after enrollment
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Faculty of Medicine
Al Mansurah, Aldakahlia, 35516
Moataz M Emara, MD, EDAIC, 01064048848, mm.emara@mans.edu.eg
About this study
Official title: Oral Dexamethasone at Night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial
Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone at night before surgery in preventing PONV after elective laparoscopic cholecystectomy.
Read the detailed description
Background:
Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone 12 hours before induction of anesthesia in preventing PONV after elective laparoscopic cholecystectomy, as it reaches its peak effect at 2-12 hours and lasts for 72 hours after oral administration.
Methods:
This is a parallel, two-arm, randomized (1:1), controlled, single-center non-inferiority trial. Adults (≥18 years) with ASA physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The participants will be randomized to receive either 8 mg of IV Dexamethasone at the time of induction of anesthesia or 8 mg of oral Dexamethasone 12 hours before induction of anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 814 patients are intended to be recruited for this non-inferiority trial.
Discussion:
The current randomized trial is exploring the non-inferiority and feasibility of oral dexamethasone at night to reduce the PONV after laparoscopic cholecystectomy when compared to the standard of care - intravenous dexamethasone at the time of induction. Additionally, the investigators suppose oral dexamethasone at night is easier to administer, avoids polypharmacy at the time of induction of anesthesia, avoids the unpleasant sensation of intravenous injection, and is at a lower cost for a one-day surgery.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Dexamethasone Oral, Dexamethasone
- 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.
Dexamethasone OralDrug
Patients in the intervention group will receive oral 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded.
DexamethasoneDrug
Patients in the control group will receive intravenous 8 mg dexamethasone just before or at the induction of anesthesia. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensations in injection.
| Study group | Role | What they receive |
|---|---|---|
| At-night oral dexamethasone | Experimental | Patients in the intervention group will receive oral 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded. Receives: Drug: Dexamethasone Oral |
| At-induction dexamethasone | Active comparator | Patients in the control group will receive intravenous 8 mg dexamethasone just before or at the induction of anesthesia. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensations in injection. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea or vomiting (PONV)
incidecne of PONV
Measured: 24 hours after surgery
Secondary outcomes (8)
Rescue antiemetic
need for rescue antiemetic for 24 hours after surgery (Dichotomous yes/no outcome)
Measured: 24 hours after surgery
Early PONV
(Dichotomous yes/no outcome)
Measured: within 6 hours after surgery
Late PONV
(Dichotomous yes/no outcome)
Measured: 6 - 24 hours after surgery
Visual Analogue Scale (VAS) at the time of discharge from PACU
On VAS scale as numerical outcome
Measured: within 2 hours at the time of discharge from PACU
VAS at the time of discharge from hospital
On VAS scale as numerical outcome
Measured: after 24 hours at the time of discharge from the hospital
Postoperative fatigue
on a 10-point scale
Measured: after 24 hours at the time of discharge from the hospital
Postoperative quality of recovery
using the QoR-15 questionnaire
Measured: after 24 hours at the time of discharge from the hospital
Post-Discharge Nausea and Vomiting (PDNV)
evaluated by telephone as a binary outcome
Measured: 72 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start4 Mar 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
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.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel, two-arm, randomized (1:1), controlled, single-center non-inferiority trial. Adults (≥18 years) with ASA physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The participants will be randomized to receive either 8 mg of IV Dexamethasone at the time of induction of anesthesia or 8 mg of oral Dexamethasone at night before surgery. The primary outcome will be the incidence of postoperative nausea and vomiting. 814 patients are intended to be recruited for this non-inferiority trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 814 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moataz M Emara, MD, EDAIC, Principal investigator, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288035
- Sponsor's protocol ID
- R.21.02.1191
- Status last verified
- Feb 2024
- First submitted
- 24 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available with the principal investigator on a reasonable request after approval of the local IRB.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Dexamethasone at Night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06288035
- Acronym / sponsor ID
- R.21.02.1191
- Conditions
- Postoperative Nausea and Vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 814 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 1 Mar 2024 (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.
Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone at night before surgery in preventing PONV after elective laparoscopic cholecystectomy.
Detailed description
Background:
Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone 12 hours before induction of anesthesia in preventing PONV after elective laparoscopic cholecystectomy, as it reaches its peak effect at 2-12 hours and lasts for 72 hours after oral administration.
Methods:
This is a parallel, two-arm, randomized (1:1), controlled, single-center non-inferiority trial. Adults (≥18 years) with ASA physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The participants will be randomized to receive either 8 mg of IV Dexamethasone at the time of induction of anesthesia or 8 mg of oral Dexamethasone 12 hours before induction of anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 814 patients are intended to be recruited for this non-inferiority trial.
Discussion:
The current randomized trial is exploring the non-inferiority and feasibility of oral dexamethasone at night to reduce the PONV after laparoscopic cholecystectomy when compared to the standard of care - intravenous dexamethasone at the time of induction. Additionally, the investigators suppose oral dexamethasone at night is easier to administer, avoids polypharmacy at the time of induction of anesthesia, avoids the unpleasant sensation of intravenous injection, and is at a lower cost for a one-day surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a parallel, two-arm, randomized (1:1), controlled, single-center non-inferiority trial. Adults (≥18 years) with ASA physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The participants will be randomized to receive either 8 mg of IV Dexamethasone at the time of induction of anesthesia or 8 mg of oral Dexamethasone at night before surgery. The primary outcome will be the incidence of postoperative nausea and vomiting. 814 patients are intended to be recruited for this non-inferiority trial.
| Arm | Type | Receives |
|---|---|---|
| At-night oral dexamethasone | Experimental | Drug: Dexamethasone OralPatients in the intervention group will receive oral 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded. |
| At-induction dexamethasone | Active comparator | Drug: DexamethasonePatients in the control group will receive intravenous 8 mg dexamethasone just before or at the induction of anesthesia. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensations in injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all consecutive adults (older than 18 years) with ASA physical status I-III undergoing elective laparoscopic cholecystectomy surgery.
Key exclusion criteria (9 listed)
- steroids or antiemetics within 1 week of surgery
- chronic opioid therapy
- history of allergy to any of the study drug
- serum creatinine > 1.4 mg/dl
- liver enzymes > triple the normal limits
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 |
|---|---|---|
| Dexamethasone OralPatients in the intervention group will receive oral 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded. | Drug | At-night oral dexamethasone |
| DexamethasonePatients in the control group will receive intravenous 8 mg dexamethasone just before or at the induction of anesthesia. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensations in injection. | Drug | At-induction dexamethasone |
Primary outcome
Postoperative nausea or vomiting (PONV)
Time frame: 24 hours after surgery
incidecne of PONV
8 secondary outcomes
Rescue antiemetic
Time frame: 24 hours after surgery
Early PONV
Time frame: within 6 hours after surgery
Late PONV
Time frame: 6 - 24 hours after surgery
Visual Analogue Scale (VAS) at the time of discharge from PACU
Time frame: within 2 hours at the time of discharge from PACU
VAS at the time of discharge from hospital
Time frame: after 24 hours at the time of discharge from the hospital
Postoperative fatigue
Time frame: after 24 hours at the time of discharge from the hospital
Postoperative quality of recovery
Time frame: after 24 hours at the time of discharge from the hospital
Post-Discharge Nausea and Vomiting (PDNV)
Time frame: 72 hours after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Yes. Data will be available with the principal investigator on a reasonable request after approval of the local IRB.
Related trials for Postoperative Nausea and Vomiting
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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
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Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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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.
Moataz M Emara, MD, EDAIC principal investigator
Mansoura University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone Oral and Dexamethasone in people with Postoperative Nausea and Vomiting, run by Mansoura University at 1 site in Egypt.
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 9 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moataz M Emara, MD, EDAIC (+201064048848, mm.emara@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative nausea or vomiting (PONV) (time frame: 24 hours after surgery). 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 12 Mar 2024.