Postoperative Nausea and VomitingPhase 2NCT06017167
Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
A Phase 2 study testing Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline . and Ondansetron 4mg + dexamethasone 8mg + normal saline. in people with Postoperative Nausea and Vomiting and Laparoscopic Cholecystectomy, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of the study is to compare antiemetic effects between dexmedetomidine and ondansteron in the first group versus dexamethasone and ondansteron in the second group. The primary outcome in this study is incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting, Laparoscopic Cholecystectomy
- What is being tested?
- Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline . and Ondansetron 4mg + dexamethasone 8mg + normal saline.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2022to Oct 2023
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 70 Female patients aged between 18 and 65 years
- ASA I or II
- patients scheduled for elective laparoscopic cholecystectomy surgery will be included in this study.
Who cannot join
- Females above 65 years old.
- patients under 18 years old.
- ASA > II.
- Obesity (BMI>40 kgm2).
- Known hypersensitivity to drugs used in the study protocol.
- Comorbidities that were known to increase the risk of PONV (e.g. vestibular disease).
Show all 9Show fewer
- Liver or renal dysfunction (liver enzyme or creatinine 1.5 times higher than normal).
- Alcoholism or drug abuse.
- Use of antiemetics and psychotropic drugs or glucocorticoids within 24 h before surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University hospitals
Tanta, Algharbia, 31511
Sohair Soliman, professor, 00201283929049, sohairsoliman@hotmail.com
Rehab Elkalla, M.D, 01285700765, rehab.mohamed@med.tanta.edu.eg
About this study
Official title: Dexmedetomidine Versus Dexamethasone Adding to Ondansetron for Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
The aim of the study is to compare antiemetic effects between dexmedetomidine and ondansteron in the first group versus dexamethasone and ondansteron in the second group.
The primary outcome in this study is incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.
The secondary outcomes are:
- The severity of post operative nausea and vomiting.
- Use of rescue antiemetic drugs.
- Postoperative pain and sedation.
Read the detailed description
General anesthesia is widely used in several surgeries. It can cause some complications such as postoperative nausea and vomiting (PONV). PONV is more common in general anesthesia than spinal anesthesia. PONV remains an extremely significant challenge due to its complex mechanism, resulting in serious consequences. Therefore an effective way to prevent or arrest PONV is urgently needed as Also, it can cause electrolyte imbalance and aggravate bleeding that delay hospital discharge.
The causes of PONV are multifactorial and can largely be categorized as patient risk factors, anaesthetic technique, and surgical procedure. Antiemetics work on several different receptor sites to prevent or treat PONV.
No single antiemetic pharmaceutical has been provided to be a universal solution to PONV. In general, multimodal combination treatment has superior viability for PONV prophylaxis compared with monotherapy .
Because nausea and vomiting were defined as two separate phe-nomena, studies should report and evaluate the variables distinctly . While since few patients experience vomiting without nausea, the incidence of PONV and postoperative nau¬sea (PON) is fairly similar, thus original papers often do not try to distinguish these variables . So, if PONV but not PON was reported in trails, we considered the PONV variables as a very close substitute for PON; when both PONV and PON were reported simultaneously, we assessed the nausea values. The most com¬monly used time interval to measure the role of antiemetic is 24 hours 6.
Ondansetron is a serotonin receptor antagonist, which is very important in preventing nausea and vomiting due to surgery and chemotherapy; it exhibited an anti-vomiting effect by inhibiting 5-Hydroxytryptamine type 3 (5-HT3) receptors in the vomiting centre .
Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist, which binds to transmembrane G protein-binding receptor located in the brain and spinal cord. Since nausea and vomit¬ing may be induced by high catecholamine con¬centrations, a decrease of sympathetic tone could explain the antiemetic effect of dexme¬detomidine. Finally, consumption of intraopera¬tive opioids, which increases the risk of PONV , may be reduced through the use of dexmedetomidine It affects the functions of central nervous, circulatory systems and exhibits sedative, analgesic, sympatholytic properties. Recently, the effect of dexmedetomidine on PONV has been the focus of clinical researchers. Nevertheless, controversy about the effectiveness of dexmedetomidine for PONV is still ongoing, for different results reported in associated literature.
Glucocorticoids may exert an antiemetic effect by inhibiting inflammatory mediators and by interacting with serotonin, neurokinin, a-adrenergic receptors, and other receptors. Furthermore, several studies have shown that dexamethasone enhances the antiemetic efficacies of 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists.
- Being tested
- Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline ., Ondansetron 4mg + dexamethasone 8mg + normal saline.
- Keywords
- dexamethasone, dexmedetomidine, ondansetron
- 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.
Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline .Drug
Also called ondansetron 4mg (Zofran; GlaxoSmithKline, Alexandria, USA, dexmedetomidine (Precedex; Ho-Spira Inc., Lake Forest, Illinois, USA
compare antiemetic effects between dexmedetomidine and ondansetron in the first group versus dexamethasone and ondansetron in the second group
Ondansetron 4mg + dexamethasone 8mg + normal saline.Drug
Also called ondansetron 4mg (Zofran; GlaxoSmithKline, Alexandria, USA, dexamethasone; Amriya Pharmaceutical Industries, Egypt
Group II: Ondansetron 4mg + dexamethasone 8mg + normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Active comparator | will receive ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes. Receives: Drug: Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline . |
| Dexamethasone Group | Active comparator | will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml. volume IV infusion over 10 minutes. Receives: Drug: Ondansetron 4mg + dexamethasone 8mg + normal saline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.
The incidence of vomiting, use of rescue antiemetics, and analgesic requirements were recorded at 0 to 1 hours after surgery in the postanesthetic care unit (PACU)At 6 and 24 hours after surgery, the incidence and severity of PONV were assessed using the Rhodes Index of nausea, vomiting, and retching.
Measured: through out 24 hours after surgery.
Secondary outcomes (3)
The severity of post operative nausea and vomiting.
The severity of nausea was evaluated using a 10-point numerical rating scale (NRS) At 6 and 24 hours after surgery, the incidence and severity of PONV were assessed using the Rhodes Index of nausea, vomiting, and reteching.At 6 and 24 hours after surgery.
The Rhodes Index is a reliable and valid patient self-reporting tool to assess nausea, vomiting, and retching and consists of eight items with 5 scales (0-4). This index has been shown to be a highly reliable method for evaluating gastrointestinal distress after ambulatory surgery.
Measured: During 24 hours after surgery.
- Postoperative pain
Pain score was also assessed using a 10-point NRS.
Measured: During 24 hours after surgery.
- Postoperative sedation
Ramsay sedation score (1=agitated, anxious, or restless; 2=oriented, cooperated, and tranquil; 3=responsive to verbal commands only; 4=asleep, brisk response to a loud auditory stimulus or a light glabella tap; 5=sluggish response to a glabella tap or loud auditory stimulus; 6=no response to a loud auditory stimulus or a light glabella tap) were recorded. Over-sedation was defined as a Ramsay sedation score>4.
Measured: During 24 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 posted30 Aug 2023
- Study start15 Sep 2022
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Tanta 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly classified with computer generated random numbers into two equal groups (each group 35 patients) Group I: will receive Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes. Group II: will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml volume IV ifusion over 10 minutes.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yasmine mohammed mahmoud mustafa eldeba, Tanta University
- Investigators
- Mohamed A. Lotfy, PHD, Principal investigator, Assistant Professor of Anesthesia and Intensive Care, Tanta Univ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017167
- Sponsor's protocol ID
- PONV after lap cholecystectomy
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be available with the principle investigator within 6 months after publishing the study
Publications
Rhodes VA, McDaniel RW. The Index of Nausea, Vomiting, and Retching: a new format of the lndex of Nausea and Vomiting. Oncol Nurs Forum. 1999 Jun;26(5):889-94.
PubMed 10382187
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 Versus Dexamethasone Adding to Ondansetron for Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06017167
- Acronym / sponsor ID
- PONV after lap cholecystectomy
- Keywords
- dexamethasone, dexmedetomidine, ondansetron
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 30 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.
The aim of the study is to compare antiemetic effects between dexmedetomidine and ondansteron in the first group versus dexamethasone and ondansteron in the second group.
The primary outcome in this study is incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.
The secondary outcomes are:
- The severity of post operative nausea and vomiting.
- Use of rescue antiemetic drugs.
- Postoperative pain and sedation.
Detailed description
General anesthesia is widely used in several surgeries. It can cause some complications such as postoperative nausea and vomiting (PONV). PONV is more common in general anesthesia than spinal anesthesia. PONV remains an extremely significant challenge due to its complex mechanism, resulting in serious consequences. Therefore an effective way to prevent or arrest PONV is urgently needed as Also, it can cause electrolyte imbalance and aggravate bleeding that delay hospital discharge.
The causes of PONV are multifactorial and can largely be categorized as patient risk factors, anaesthetic technique, and surgical procedure. Antiemetics work on several different receptor sites to prevent or treat PONV.
No single antiemetic pharmaceutical has been provided to be a universal solution to PONV. In general, multimodal combination treatment has superior viability for PONV prophylaxis compared with monotherapy .
Because nausea and vomiting were defined as two separate phe-nomena, studies should report and evaluate the variables distinctly . While since few patients experience vomiting without nausea, the incidence of PONV and postoperative nau¬sea (PON) is fairly similar, thus original papers often do not try to distinguish these variables . So, if PONV but not PON was reported in trails, we considered the PONV variables as a very close substitute for PON; when both PONV and PON were reported simultaneously, we assessed the nausea values. The most com¬monly used time interval to measure the role of antiemetic is 24 hours 6.
Ondansetron is a serotonin receptor antagonist, which is very important in preventing nausea and vomiting due to surgery and chemotherapy; it exhibited an anti-vomiting effect by inhibiting 5-Hydroxytryptamine type 3 (5-HT3) receptors in the vomiting centre .
Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist, which binds to transmembrane G protein-binding receptor located in the brain and spinal cord. Since nausea and vomit¬ing may be induced by high catecholamine con¬centrations, a decrease of sympathetic tone could explain the antiemetic effect of dexme¬detomidine. Finally, consumption of intraopera¬tive opioids, which increases the risk of PONV , may be reduced through the use of dexmedetomidine It affects the functions of central nervous, circulatory systems and exhibits sedative, analgesic, sympatholytic properties. Recently, the effect of dexmedetomidine on PONV has been the focus of clinical researchers. Nevertheless, controversy about the effectiveness of dexmedetomidine for PONV is still ongoing, for different results reported in associated literature.
Glucocorticoids may exert an antiemetic effect by inhibiting inflammatory mediators and by interacting with serotonin, neurokinin, a-adrenergic receptors, and other receptors. Furthermore, several studies have shown that dexamethasone enhances the antiemetic efficacies of 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly classified with computer generated random numbers into two equal groups (each group 35 patients) Group I: will receive Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes. Group II: will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml volume IV ifusion over 10 minutes.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Active comparator | Drug: Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline .will receive ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes. |
| Dexamethasone Group | Active comparator | Drug: Ondansetron 4mg + dexamethasone 8mg + normal saline.will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml. volume IV infusion over 10 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 70 Female patients aged between 18 and 65 years
- ASA I or II
- patients scheduled for elective laparoscopic cholecystectomy surgery will be included in this study.
Key exclusion criteria (9 listed)
- Females above 65 years old.
- patients under 18 years old.
- ASA > II.
- Obesity (BMI>40 kgm2).
- Known hypersensitivity to drugs used in the study protocol.
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 |
|---|---|---|
| Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline .Also: ondansetron 4mg (Zofran; GlaxoSmithKline, Alexandria, USA, dexmedetomidine (Precedex; Ho-Spira Inc., Lake Forest, Illinois, USAcompare antiemetic effects between dexmedetomidine and ondansetron in the first group versus dexamethasone and ondansetron in the second group | Drug | Dexmedetomidine Group |
| Ondansetron 4mg + dexamethasone 8mg + normal saline.Also: ondansetron 4mg (Zofran; GlaxoSmithKline, Alexandria, USA, dexamethasone; Amriya Pharmaceutical Industries, EgyptGroup II: Ondansetron 4mg + dexamethasone 8mg + normal saline. | Drug | Dexamethasone Group |
Primary outcome
The incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.
Time frame: through out 24 hours after surgery.
The incidence of vomiting, use of rescue antiemetics, and analgesic requirements were recorded at 0 to 1 hours after surgery in the postanesthetic care unit (PACU)At 6 and 24 hours after surgery, the incidence and severity of PONV were assessed using the Rhodes Index of nausea, vomiting, and retching.
3 secondary outcomes
The severity of post operative nausea and vomiting.
Time frame: During 24 hours after surgery.
- Postoperative pain
Time frame: During 24 hours after surgery.
- Postoperative sedation
Time frame: During 24 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 30 Aug 2023.
- Background: PubMed 10382187Rhodes VA, McDaniel RW. The Index of Nausea, Vomiting, and Retching: a new format of the lndex of Nausea and Vomiting. Oncol Nurs Forum. 1999 Jun;26(5):889-94.
- Individual participant dataSharing planned: Yes. The IPD will be available with the principle investigator within 6 months after publishing the study
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
Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
Postoperative Vomiting, 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.
Mohamed A. Lotfy, PHD principal investigator
Assistant Professor of Anesthesia and Intensive Care, Tanta Univ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline . and Ondansetron 4mg + dexamethasone 8mg + normal saline. in people with Postoperative Nausea and Vomiting and Laparoscopic Cholecystectomy, run by Tanta 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 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 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yasmine M. Eldeba, BA (0021097732321, yasmine162078_pg@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy. (time frame: through out 24 hours after surgery.). 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 NCT06017167, which also lists 1 linked publication.
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.