Postoperative Nausea and VomitingNCT05134363
Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.
A study testing Dexmedetomidine Hydrochloride 0.5 mic/kg bolus and Dexmedetomidine Hydrochloride 0.75 mic/kg bolus in people with Postoperative Nausea and Vomiting and Head and Neck Surgeries, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims to compare between two bolus doses of dexmedetomidine in preventing PONV in highly susceptible patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting, Head and Neck Surgeries
- What is being tested?
- Dexmedetomidine Hydrochloride 0.5 mic/kg bolus and Dexmedetomidine Hydrochloride 0.75 mic/kg bolus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Aug 2021to 20 Jun 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Two risk factors or more for PONV ( female, non-smoking, postoperative opioids, history of motion sickness or PONV )
- Head and neck surgeries in adults
- ASA ( I , II )
Who cannot join
- Patients on ( steroids , antiemetics or any drug caude emesis )
- Any active cardiac condition at the time of the surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine for Prophylaxis Against Postoperative Nausea and Vomiting in Highly Susceptible Patients: a Randomised Controlled Comparison of Two Bolus Doses
The study aims to compare between two bolus doses of dexmedetomidine in preventing PONV in highly susceptible patients.
Read the detailed description
Being A challenging complaint, many studies tried to find an effective preventive strategies for PONV. In this study protocol the investigators aim to compare between 0.5 mic/kg and 0.75 mic/kg bolus doses of dexmedetomidine when given toward the end of head and neck surgeries in highly susceptible patients with a controlled group receiving ondansetron.
The primary outcome is the 1st 24 hours incidence of PONV
Other outcomes include:
- Time to 1st call for rescue antiemetic and the total amount of antiemetics
- Number of PONV attacks
- Post operative pain score with visual analogous scale (VAS) and time to 1st call for rescue analgesia
- Sedation Score using Observer's Assessment of Alertness and sedation (OAA/S)
- Patient satisfaction
- Vital signs in the 1st 24 hours
- Being tested
- Dexmedetomidine Hydrochloride 0.5 mic/kg bolus, Dexmedetomidine Hydrochloride 0.75 mic/kg bolus, Placebo
- Keywords
- Dexmedetomidine, PONV, ondansetron, post operative, nausea, vomiting
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Hydrochloride 0.5 mic/kg bolusDrug
comparison between two bolus doses of dexmedetomidine with a placebo group
Dexmedetomidine Hydrochloride 0.75 mic/kg bolusDrug
comparison between two bolus doses of dexmedetomidine with a conventional group receiving ondansetron.
PlaceboDrug
equal volume of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine 0.5 mic/kg bolus | Active comparator | selective alpha 2 adrenergic receptor agonist Receives: Drug: Dexmedetomidine Hydrochloride 0.5 mic/kg bolus |
| dexmedetomidine 0.75 mic/kg bllus | Active comparator | selective alpha 2 adrenergic receptor agonist Receives: Drug: Dexmedetomidine Hydrochloride 0.75 mic/kg bolus |
| Placebo group | Placebo comparator | receving equal volume of normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PONV in the 1st 24 hours postoperatively
The overall incidence of nausea and vomiting in the 1st 24 hours following Head and neck surgeries.
Measured: The first 24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Secondary outcomes (10)
Number of PONV attacks
Number of PONV attacks in the 1st 24 hours following Head and neck surgeries
Measured: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Pain score postoperatively.
Pain assessement using visual analogous scale score (0-10) with 10 denoting the worst pain expressed and zero= no pain
Measured: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Sedation score
using Observer's assessment of ALERTNESS and Sedation (1-5)with 1 = unconscious and 5= Alert
Measured: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Patient satisfaction
The patient completes a simple questionnaire with 0= very satisfied 1 = satisfied 2= not satisfied
Measured: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Blood pressure
Mean arterial blood pressure (MAP) in the 1st 24 hours
Measured: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Heart Rate (HR)
Pulse rate in the 1st 24 hours
Measured: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
The time to 1st call for rescue antiemetic
time to 1st call for rescue antiemetic and the severity of nausea ( using the 11 verbal 11-point rating scale 0= no nausea 10= the worst nausea
Measured: In the 1st 24 hours
The severity of nausea.
the severity of nausea ( using the 11 verbal 11-point rating scale 0= no nausea 10= the worst nausea
Measured: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Total amount of morphine consumption
morphine consumed in thw 1st 24 hours in milligrams.
Measured: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
The time to 1st call for rescue analgesia
time to 1st call for rescure analgesic medication in the 1st 24 hours postoperatively
Measured: In the first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start11 Aug 2021
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparative study between two doses and a 3rd control group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Raafat Mahmoud Seif, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134363
- Sponsor's protocol ID
- MD-208-2021
- Status last verified
- Aug 2023
- First submitted
- 30 Oct 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
PubMed 10485781Kim SH, Oh YJ, Park BW, Sim J, Choi YS. Effects of single-dose dexmedetomidine on the quality of recovery after modified radical mastectomy: a randomised controlled trial. Minerva Anestesiol. 2013 Nov;79(11):1248-58. Epub 2013 May 23.
PubMed 23698545
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine for Prophylaxis Against Postoperative Nausea and Vomiting in Highly Susceptible Patients: a Randomised Controlled Comparison of Two Bolus Doses
- ClinicalTrials.gov ID
- NCT05134363
- Acronym / sponsor ID
- MD-208-2021
- Keywords
- Dexmedetomidine, PONV, ondansetron, post operative, nausea, vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 24 Nov 2021 (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 study aims to compare between two bolus doses of dexmedetomidine in preventing PONV in highly susceptible patients.
Detailed description
Being A challenging complaint, many studies tried to find an effective preventive strategies for PONV. In this study protocol the investigators aim to compare between 0.5 mic/kg and 0.75 mic/kg bolus doses of dexmedetomidine when given toward the end of head and neck surgeries in highly susceptible patients with a controlled group receiving ondansetron.
The primary outcome is the 1st 24 hours incidence of PONV
Other outcomes include:
- Time to 1st call for rescue antiemetic and the total amount of antiemetics
- Number of PONV attacks
- Post operative pain score with visual analogous scale (VAS) and time to 1st call for rescue analgesia
- Sedation Score using Observer's Assessment of Alertness and sedation (OAA/S)
- Patient satisfaction
- Vital signs in the 1st 24 hours
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- comparative study between two doses and a 3rd control group
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine 0.5 mic/kg bolus | Active comparator | Drug: Dexmedetomidine Hydrochloride 0.5 mic/kg bolusselective alpha 2 adrenergic receptor agonist |
| dexmedetomidine 0.75 mic/kg bllus | Active comparator | Drug: Dexmedetomidine Hydrochloride 0.75 mic/kg bolusselective alpha 2 adrenergic receptor agonist |
| Placebo group | Placebo comparator | Drug: Placeboreceving equal volume of normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Two risk factors or more for PONV ( female, non-smoking, postoperative opioids, history of motion sickness or PONV )
- Head and neck surgeries in adults
- ASA ( I , II )
Key exclusion criteria (3 listed)
- Patients on ( steroids , antiemetics or any drug caude emesis )
- Any active cardiac condition at the time of the surgery
- Pregnancy
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 |
|---|---|---|
| Dexmedetomidine Hydrochloride 0.5 mic/kg boluscomparison between two bolus doses of dexmedetomidine with a placebo group | Drug | Dexmedetomidine 0.5 mic/kg bolus |
| Dexmedetomidine Hydrochloride 0.75 mic/kg boluscomparison between two bolus doses of dexmedetomidine with a conventional group receiving ondansetron. | Drug | dexmedetomidine 0.75 mic/kg bllus |
| Placeboequal volume of normal saline | Drug | Placebo group |
Primary outcome
Incidence of PONV in the 1st 24 hours postoperatively
Time frame: The first 24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
The overall incidence of nausea and vomiting in the 1st 24 hours following Head and neck surgeries.
10 secondary outcomes
Number of PONV attacks
Time frame: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Pain score postoperatively.
Time frame: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Sedation score
Time frame: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Patient satisfaction
Time frame: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Blood pressure
Time frame: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Heart Rate (HR)
Time frame: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
The time to 1st call for rescue antiemetic
Time frame: In the 1st 24 hours
The severity of nausea.
Time frame: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
Total amount of morphine consumption
Time frame: The first24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )
The time to 1st call for rescue analgesia
Time frame: In the first 24 hours
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 30 Aug 2023.
- Background: PubMed 10485781Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
- Results publication: PubMed 23698545Kim SH, Oh YJ, Park BW, Sim J, Choi YS. Effects of single-dose dexmedetomidine on the quality of recovery after modified radical mastectomy: a randomised controlled trial. Minerva Anestesiol. 2013 Nov;79(11):1248-58. Epub 2013 May 23.
- Individual participant dataSharing planned: No
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.
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?
A study testing Dexmedetomidine Hydrochloride 0.5 mic/kg bolus and Dexmedetomidine Hydrochloride 0.75 mic/kg bolus in people with Postoperative Nausea and Vomiting and Head and Neck Surgeries, run by Cairo 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 3 inclusion and 3 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 30 Aug 2023. 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. Some participants in this study may receive a placebo. 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?
Incidence of PONV in the 1st 24 hours postoperatively (time frame: The first 24 hours ( every half an hour in the 1st 2 hours and then at 4,6,8,12 and 24 hours )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05134363, which also lists 2 linked publications.
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 30 Aug 2023.