Postoperative Nausea and VomitingPhase 2/3NCT05998317
Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy
A Phase 2/3 study testing At-night Dexamethasone and At-induction Dexamethasone in people with Postoperative Nausea and Vomiting and Postoperative Pain, run by Mansoura University at 1 site in Egypt.
Trial summary
Since the peak effect of the dexamethasone is delayed to 12-16 hours after iv administration, we designed this study to investigate the effect of administering dexamethasone at-night before surgery versus at-induction (the standard timing) in prevention of postoperative nausea and vomiting after laparoscopic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting, Postoperative Pain, Laparoscopic Cholecystectomy
- What is being tested?
- At-night Dexamethasone and At-induction Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Oct 2023to 20 Nov 2023
- Phase
- Phase 2/3
- 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 at gastrointestinal surgery center.
Who cannot join
- patient refusal
- use of steroids or antiemetic agents within 1 week of surgery
- chronic opioid therapy
- history of allergy to any study medications
- serum creatinine > 1.4 mg/dl
- liver enzymes more than triple normal limits
Show all 9Show fewer
- pregnancy
- psychiatric or neurologic diseases or socioeconomic status that would hinder postoperative quality of recovery questionnaire
- Patients whose laparoscopic surgery is converted to open surgery after enrollment will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone At-induction vs At-night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial
Since the peak effect of the dexamethasone is delayed to 12-16 hours after iv administration, we designed this study to investigate the effect of administering dexamethasone at-night before surgery versus at-induction (the standard timing) in prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy.
A pilot randomized controlled study (60 cases) will be started to explore the potential difference, ensure correct and rigorous data collection, and calculate the sample size for a larger pragmatic trial.
Read the detailed description
Background:
Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. The aim of this study is to evaluate the efficacy of administration of prophylactic dexamethasone 12-hours prior to 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 intravenous (iv) administration.
Methods:
This is a parallel two-arm, randomized (1:1), double-blind, controlled, single-center trial. Adults (≥18 years) with American Society of Anesthesiology (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 IV Dexamethasone at time of induction of anesthesia or 8 mg IV Dexamethasone at 12 hours prior to induction of anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 60 patients will be recruited as a pilot study.
- Being tested
- At-night Dexamethasone, At-induction Dexamethasone
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
At-night DexamethasoneDrug
Patients in the intervention group will receive intravenous 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.
At-induction 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 sensation in injection.
| Study group | Role | What they receive |
|---|---|---|
| At-night dexamethasone | Experimental | Patients in the intervention group will receive intravenous 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection. Receives: Drug: At-night Dexamethasone |
| 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 sensation in injection. Receives: Drug: At-induction Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative nausea or vomiting (PONV)
incidence of PONV (binary outcome as yes/No)
Measured: 24 hours after surgery
Secondary outcomes (8)
The need for rescue antiemetic
Dichotomous yes/no outcome
Measured: 24 hours after surgery
The need for rescue analgesia
Dichotomous yes/no outcome
Measured: 24 hours after surgery
Postoperative Care Unit (PACU) and 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)
VAS as a scale 0 - 10
Measured: at the time of discharge from PACU (usually at 2 hours after surgery)
Visual Analogue Scale (VAS)
VAS as a scale 0 - 10
Measured: at the time of discharge from hospital (usually 24 hours after surgery)
Postoperative quality of recovery (QoR)
QoR-15 questionnaire (doi: https://doi.org/10.1097/ALN.0b013e318289b84b)
Measured: 24 hours after surgery
Post-Discharge Nausea and Vomiting (PDNV)
evaluated by telephone by Dichotomous yes/no outcome
Measured: at 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 posted18 Aug 2023
- Study start8 Oct 2023
- Primary completion15 Nov 2023
- Study completion20 Nov 2023
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial superiority parallel trial. This is a pilot trial and the sample size will be updated after the pilot study completion and the approval of the local Institutional Review Board (IRB).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moataz M Emara, MD, EDAIC, Study chair, Mansoura University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998317
- Sponsor's protocol ID
- R.23.07.2239
- Status last verified
- Jan 2024
- First submitted
- 11 Aug 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymised data will be available on appropriate response with the prinicipal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone At-induction vs At-night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05998317
- Acronym / sponsor ID
- R.23.07.2239
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 8 Oct 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 18 Aug 2023 (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.
Since the peak effect of the dexamethasone is delayed to 12-16 hours after iv administration, we designed this study to investigate the effect of administering dexamethasone at-night before surgery versus at-induction (the standard timing) in prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy.
A pilot randomized controlled study (60 cases) will be started to explore the potential difference, ensure correct and rigorous data collection, and calculate the sample size for a larger pragmatic trial.
Detailed description
Background:
Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. The aim of this study is to evaluate the efficacy of administration of prophylactic dexamethasone 12-hours prior to 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 intravenous (iv) administration.
Methods:
This is a parallel two-arm, randomized (1:1), double-blind, controlled, single-center trial. Adults (≥18 years) with American Society of Anesthesiology (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 IV Dexamethasone at time of induction of anesthesia or 8 mg IV Dexamethasone at 12 hours prior to induction of anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 60 patients will be recruited as a pilot study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial superiority parallel trial. This is a pilot trial and the sample size will be updated after the pilot study completion and the approval of the local Institutional Review Board (IRB).
| Arm | Type | Receives |
|---|---|---|
| At-night dexamethasone | Experimental | Drug: At-night DexamethasonePatients in the intervention group will receive intravenous 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection. |
| At-induction dexamethasone | Active comparator | Drug: At-induction 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 sensation 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 at gastrointestinal surgery center.
Key exclusion criteria (9 listed)
- patient refusal
- use of steroids or antiemetic agents within 1 week of surgery
- chronic opioid therapy
- history of allergy to any study medications
- serum creatinine > 1.4 mg/dl
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 |
|---|---|---|
| At-night DexamethasonePatients in the intervention group will receive intravenous 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection. | Drug | At-night dexamethasone |
| At-induction 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 sensation in injection. | Drug | At-induction dexamethasone |
Primary outcome
postoperative nausea or vomiting (PONV)
Time frame: 24 hours after surgery
incidence of PONV (binary outcome as yes/No)
8 secondary outcomes
The need for rescue antiemetic
Time frame: 24 hours after surgery
The need for rescue analgesia
Time frame: 24 hours after surgery
Postoperative Care Unit (PACU) and Early PONV
Time frame: within 6 hours after surgery
Late PONV
Time frame: 6-24 hours after surgery
Visual Analogue Scale (VAS)
Time frame: at the time of discharge from PACU (usually at 2 hours after surgery)
Visual Analogue Scale (VAS)
Time frame: at the time of discharge from hospital (usually 24 hours after surgery)
Postoperative quality of recovery (QoR)
Time frame: 24 hours after surgery
Post-Discharge Nausea and Vomiting (PDNV)
Time frame: at 72 hours after surgery
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 25 Jan 2024.
- Individual participant dataSharing planned: Yes. The anonymised data will be available on appropriate response with the prinicipal investigator.
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Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
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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 study chair
Mansoura University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing At-night Dexamethasone and At-induction Dexamethasone in people with Postoperative Nausea and Vomiting and Postoperative Pain, 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: finished, as of the sponsor's last update on 25 Jan 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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 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 25 Jan 2024.