GIT FunctionvomitingNCT07329933
Dexamethasone, Dexmedetomidine and Their Combination on Post op. GIT Function Measured by I-FFED Score Post Laparoscopic Cholecystectomy
A study testing Dexamethasone, Dexmedetomidine and Dexamethasone and dexmedetomidine in people with GIT Function and Cholecystectomy, Laparoscopic, run by Benha University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn the effect of Dexamethasone and Dexmedetomidine and Their Combination on Post op. GIT Function Measured by I-FFED Score Post Laparoscopic Cholecystectomy What medical problems do participants have when taking Dexamethasone and Dexmedetomidine? Researchers will compare… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- GIT Function, Cholecystectomy, Laparoscopic, Dexamethasone
- What is being tested?
- Dexamethasone, Dexmedetomidine and Dexamethasone and dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . Age 18-65 years.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Scheduled for elective laparoscopic cholecystectomy surgery under general anesthesia.
- Ability to provide written informed consent
Who cannot join
- Known allergy or contraindication to any study drug (dexamethasone, dexmedetomidine, or placebo).
- Pre-existing gastrointestinal motility disorders (e.g., gastroparesis, inflammatory bowel disease).
- Chronic use of opioids, steroids, or antiemetics.
- History of severe cardiac disease (e.g., high-grade AV block, severe bradycardia).
- Uncontrolled diabetes mellitus (HbA1c > 8.0%).
- Emergency surgery or conversion to open surgery.
Show all 9Show fewer
- Pregnancy or breastfeeding.
- Morbid obesity (BMI >40).
- Severe hepatic or renal dysfunction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Benha University Hospital
Banhā
Taghreed Sakr, MD degree of anesthesia, 00201112723187, taghreed.sakr@fmed.bu.edu.eg
About this study
Official title: Effect of Dexamethasone, Dexmedetomidine and Their Combination on Postoperative Gastrointestinal Function Measured by I-FEED Score After Elective Laparoscopic Cholecystectomy Surgery: a Randomized Controlled Trial
The goal of this clinical trial is to learn the effect of Dexamethasone and Dexmedetomidine and Their Combination on Post op. GIT Function Measured by I-FFED Score Post Laparoscopic Cholecystectomy
What medical problems do participants have when taking Dexamethasone and Dexmedetomidine? Researchers will compare Dexamethasone and Dexmedetomidine and Their Combination to a placebo (a look-alike substance that contains no drug) to see the effect on Post op. GIT Function Measured by I-FFED Score Post Laparoscopic Cholecystectomy Participants will receive Dexamethasone 8 mg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.
Read more
Participants will receive Dexmedetomidine 0.5 mcg /kg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.
Participants will receive Dexamethasone 8 mg IV + Dexmedetomidine 0.5 mcg/kg IV+ Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.
Participants will receive Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia
- Being tested
- Dexamethasone, Dexmedetomidine, Dexamethasone and dexmedetomidine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Participants will receive Dexamethasone 8 mg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.
DexmedetomidineDrug
Participants will receive Dexmedetomidine 0.5 mcg /kg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.
Dexamethasone and dexmedetomidineDrug
Participants will receive Dexamethasone 8 mg IV + Dexmedetomidine 0.5 mcg/kg IV+ Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia
PlaceboDrug
Participants will receive Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group D (Dexamethasone) | Active comparator | Not described Receives: Drug: Dexamethasone |
| Group X (Dexmedetomidine) | Active comparator | Not described Receives: Drug: Dexmedetomidine |
| Group DX (Combination) | Active comparator | Not described Receives: Drug: Dexamethasone and dexmedetomidine |
| Group P (Placebo) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The highest I-FEED score
recorded daily from Postoperative Day (POD) 1 to POD 2. The I FEED score is calculated based on five components: Intake, Feeling nauseated, Emesis, Examination, and Duration of symptoms
Measured: 24 -48 hours post operative
Secondary outcomes (7)
Time (hours) to first flatus and first defecation
Measured: 24-48 hours post operative
Time to tolerate oral intake.
Measured: 24-48 hours postoperative
incidence of POGD (defined as I-FEED score > 2)
Measured: 24-48 hours postoperative
postoperative nausea and vomiting (PONV), Incidence and severity
Measured: 24-48 hours
• Length of hospital stay (days) from surgery to discharge
Measured: 1 week post operative
• Any adverse events related to study drugs
Measured: 24-48 hours postoperative
Total rescue opioid consumption
Measured: 24-48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start15 Dec 2025
- Primary completion1 May 2026
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GIT FunctionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taghreed Elshahat Sakr, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329933
- Sponsor's protocol ID
- RC.3.11.2025
- Acronym
- vomiting
- Status last verified
- Jul 2026
- First submitted
- 29 Dec 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone, Dexmedetomidine and Their Combination on Postoperative Gastrointestinal Function Measured by I-FEED Score After Elective Laparoscopic Cholecystectomy Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07329933
- Acronym / sponsor ID
- vomiting / RC.3.11.2025
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 9 Jan 2026 (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 goal of this clinical trial is to learn the effect of Dexamethasone and Dexmedetomidine and Their Combination on Post op. GIT Function Measured by I-FFED Score Post Laparoscopic Cholecystectomy
What medical problems do participants have when taking Dexamethasone and Dexmedetomidine? Researchers will compare Dexamethasone and Dexmedetomidine and Their Combination to a placebo (a look-alike substance that contains no drug) to see the effect on Post op. GIT Function Measured by I-FFED Score Post Laparoscopic Cholecystectomy Participants will receive Dexamethasone 8 mg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.
Participants will receive Dexmedetomidine 0.5 mcg /kg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.
Participants will receive Dexamethasone 8 mg IV + Dexmedetomidine 0.5 mcg/kg IV+ Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia.
Participants will receive Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group D (Dexamethasone) | Active comparator | Drug: Dexamethasone |
| Group X (Dexmedetomidine) | Active comparator | Drug: Dexmedetomidine |
| Group DX (Combination) | Active comparator | Drug: Dexamethasone and dexmedetomidine |
| Group P (Placebo) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- . Age 18-65 years.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Scheduled for elective laparoscopic cholecystectomy surgery under general anesthesia.
- Ability to provide written informed consent
Key exclusion criteria (9 listed)
- Known allergy or contraindication to any study drug (dexamethasone, dexmedetomidine, or placebo).
- Pre-existing gastrointestinal motility disorders (e.g., gastroparesis, inflammatory bowel disease).
- Chronic use of opioids, steroids, or antiemetics.
- History of severe cardiac disease (e.g., high-grade AV block, severe bradycardia).
- Uncontrolled diabetes mellitus (HbA1c > 8.0%).
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 |
|---|---|---|
| DexamethasoneParticipants will receive Dexamethasone 8 mg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia. | Drug | Group D (Dexamethasone) |
| DexmedetomidineParticipants will receive Dexmedetomidine 0.5 mcg /kg IV + Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia. | Drug | Group X (Dexmedetomidine) |
| Dexamethasone and dexmedetomidineParticipants will receive Dexamethasone 8 mg IV + Dexmedetomidine 0.5 mcg/kg IV+ Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia | Drug | Group DX (Combination) |
| PlaceboParticipants will receive Saline IV (total volume 10 ml) over 10 minutes administered after induction of anesthesia | Drug | Group P (Placebo) |
Primary outcome
The highest I-FEED score
Time frame: 24 -48 hours post operative
recorded daily from Postoperative Day (POD) 1 to POD 2. The I FEED score is calculated based on five components: Intake, Feeling nauseated, Emesis, Examination, and Duration of symptoms
7 secondary outcomes
Time (hours) to first flatus and first defecation
Time frame: 24-48 hours post operative
Time to tolerate oral intake.
Time frame: 24-48 hours postoperative
incidence of POGD (defined as I-FEED score > 2)
Time frame: 24-48 hours postoperative
postoperative nausea and vomiting (PONV), Incidence and severity
Time frame: 24-48 hours
• Length of hospital stay (days) from surgery to discharge
Time frame: 1 week post operative
• Any adverse events related to study drugs
Time frame: 24-48 hours postoperative
Total rescue opioid consumption
Time frame: 24-48 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone, Dexmedetomidine and Dexamethasone and dexmedetomidine in people with GIT Function and Cholecystectomy, Laparoscopic, run by Benha 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 4 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The highest I-FEED score (time frame: 24 -48 hours post operative). 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 20 Jul 2026.