DexmedetomidineNCT06634524
Effect of Dexmedetomidine on Gastric Emptying, Assessed by Ultrasound in Laparoscopic Cholecystectomy
A study testing Dexmeditomidine and Normal saline in people with Dexmedetomidine and Gastric Emptying, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of dexmedetomidine on gastric emptying assessed by gastric ultrasound in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Dexmedetomidine, Gastric Emptying, Ultrasound
- What is being tested?
- Dexmeditomidine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Oct 2024to 1 Mar 2025
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 21 to 65 years old.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Undergoing elective laparoscopic cholecystectomy surgery
Who cannot join
- Patient's refusal.
- Patients with abnormalities in gastrointestinal tracts (including previous esophageal or gastric surgery, tumors or stricture).
- Failure to follow preoperative fasting guidelines.
- Patients with a body mass index ≥ 35
- Patients on regular treatment of antacids or prokinetic.
- Presence of history of disease causing an increase in the incidence of delayed gastric emptying such as: diabetes mellitus, obesity or electrolyte disturbances.
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- Pregnancy.
- Presence of hepatic or renal dysfunction.
- Presence of existing condition causing bradycardia such as heart block, or patients on regular calcium channel blockers or beta blockers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dexmedetomidine on Gastric Emptying, Assessed by Ultrasound, in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Trial.
The aim of this study is to evaluate the effect of dexmedetomidine on gastric emptying assessed by gastric ultrasound in patients undergoing laparoscopic cholecystectomy.
Read the detailed description
Delayed return of normal gastrointestinal function, and postoperative nausea and vomiting (PONV) are common adverse events of laparoscopic cholecystectomy under general anesthesia. Sympathetic stimulation, intra-abdominal carbon dioxide insufflation, and the consequent visceral peritoneal irritation are all contributing factors. In addition, anesthetic agents and opioids can also have a harmful impact on gastric emptying.
Dexmedetomidine, a potent and highly selective alpha-2 adrenoreceptor agonist, is frequently employed as an anesthetic adjunct in surgical procedures. By reducing the surgical stress response through its central sympatholytic and anti-inflammatory effects, dexmedetomidine offers distinct organ protection. Furthermore, its opioid-sparing effect reduces the need for perioperative analgesics.
A recent meta-analysis reported a positive impact of perioperative dexmedetomidine use on postoperative gastrointestinal function by shortening the time to pass flatus.The use of gastric ultrasound to assess cross-sectional area of the stomach and it's volume may provide better insight into the effect of dexmedetomidine on gastrointestinal function.
- Being tested
- Dexmeditomidine, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmeditomidineDrug
Also called Group D
Patients who will receive IV infusion of (0.2 µg/kg/hr dexmeditomidine).
Normal salineDrug
Also called Group C
Patients who will receive IV infusion of normal saline, at the same rate of dexmedetomidine infusion.
| Study group | Role | What they receive |
|---|---|---|
| Dexmeditomidine group | Experimental | Patients who will receive IV infusion of (0.2 µg/kg/hr dexmeditomidine). Receives: Drug: Dexmeditomidine |
| Control group | Placebo comparator | Patients who will receive IV infusion of normal saline, at the same rate of dexmedetomidine infusion Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of gastric volume with the aid of ultrasound
Gastric ultrasound will be used to measure gastric volume through cross-sectional area before induction, and 1 and 3 hours postoperatively.
Estimated gastric volumes will be calculated using a previously validated formula: gastric volume (mL) = 27.0 + (14.6 ×CSA) - (1.28 ×Age).
Measured: 3 hours postoperatively
Secondary outcomes (3)
Measurement of cross-sectional area of gastric antrum
Gastric ultrasound will be used to measure gastric volume through cross sectional area. Gastric antrum images will be obtained using 2 - 5 MHz curvilinear probe which will be positioned in the sagittal plane of epigastric region. All imaging attempts will be carried out at 2 positions: semi-recumbent and right lateral. Images of gastric antrum will be obtained by identifying the following landmarks - left anterior lobe of the liver anteriorly, inferior vena cava and abdominal aorta posteriorly.
Measured: 3 hours postoperatively
Gastric content assessment.
We initially will assess the nature (nil, fluid, or solid particles) of the gastric contents. An empty stomach will appear as the antrum walls juxtaposed with a "fat" appearance. The clear fluid will appear as "homogeneously hypoechoic" liquid content without residues.
Quantitative assessment of gastric contents will be carried out by measuring the anteroposterior (AP) and craniocaudal (CC) diameters of the gastric antrum 3 times for each ultrasonographic assessment. The mean value of the 3 will be recorded. The universally accepted 2 -diameter -method will be used for the measurement of antrum cross-sectional area (CSA) because it's simple and easy to perform. It will be assessed before induction of anesthesia and at the 1-hour and 3-hour post-operative marks in post anesthesia care unit (PACU).
Measured: 3-hour post-operative marks in post anesthesia care unit (PACU).
Relation between gastric cross-sectional area to time of passage of flatus
Time of passage of flatus will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start12 Oct 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noran Hesham Mohammed Elsaid Borg, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634524
- Sponsor's protocol ID
- 36264MS663/8/24
- Status last verified
- Sep 2025
- First submitted
- 8 Oct 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on Gastric Emptying, Assessed by Ultrasound, in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT06634524
- Acronym / sponsor ID
- 36264MS663/8/24
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 12 Oct 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 10 Oct 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.
The aim of this study is to evaluate the effect of dexmedetomidine on gastric emptying assessed by gastric ultrasound in patients undergoing laparoscopic cholecystectomy.
Detailed description
Delayed return of normal gastrointestinal function, and postoperative nausea and vomiting (PONV) are common adverse events of laparoscopic cholecystectomy under general anesthesia. Sympathetic stimulation, intra-abdominal carbon dioxide insufflation, and the consequent visceral peritoneal irritation are all contributing factors. In addition, anesthetic agents and opioids can also have a harmful impact on gastric emptying.
Dexmedetomidine, a potent and highly selective alpha-2 adrenoreceptor agonist, is frequently employed as an anesthetic adjunct in surgical procedures. By reducing the surgical stress response through its central sympatholytic and anti-inflammatory effects, dexmedetomidine offers distinct organ protection. Furthermore, its opioid-sparing effect reduces the need for perioperative analgesics.
A recent meta-analysis reported a positive impact of perioperative dexmedetomidine use on postoperative gastrointestinal function by shortening the time to pass flatus.The use of gastric ultrasound to assess cross-sectional area of the stomach and it's volume may provide better insight into the effect of dexmedetomidine on gastrointestinal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmeditomidine group | Experimental | Drug: DexmeditomidinePatients who will receive IV infusion of (0.2 µg/kg/hr dexmeditomidine). |
| Control group | Placebo comparator | Drug: Normal salinePatients who will receive IV infusion of normal saline, at the same rate of dexmedetomidine infusion |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 21 to 65 years old.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Undergoing elective laparoscopic cholecystectomy surgery
Key exclusion criteria (9 listed)
- Patient's refusal.
- Patients with abnormalities in gastrointestinal tracts (including previous esophageal or gastric surgery, tumors or stricture).
- Failure to follow preoperative fasting guidelines.
- Patients with a body mass index ≥ 35
- Patients on regular treatment of antacids or prokinetic.
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 |
|---|---|---|
| DexmeditomidineAlso: Group DPatients who will receive IV infusion of (0.2 µg/kg/hr dexmeditomidine). | Drug | Dexmeditomidine group |
| Normal salineAlso: Group CPatients who will receive IV infusion of normal saline, at the same rate of dexmedetomidine infusion. | Drug | Control group |
Primary outcome
Assessment of gastric volume with the aid of ultrasound
Time frame: 3 hours postoperatively
Gastric ultrasound will be used to measure gastric volume through cross-sectional area before induction, and 1 and 3 hours postoperatively. Estimated gastric volumes will be calculated using a previously validated formula: gastric volume (mL) = 27.0 + (14.6 ×CSA) - (1.28 ×Age).
3 secondary outcomes
Measurement of cross-sectional area of gastric antrum
Time frame: 3 hours postoperatively
Gastric content assessment.
Time frame: 3-hour post-operative marks in post anesthesia care unit (PACU).
Relation between gastric cross-sectional area to time of passage of flatus
Time frame: 24 hours postoperatively
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 19 Sep 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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 Dexmeditomidine and Normal saline in people with Dexmedetomidine and Gastric Emptying, 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 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: finished, as of the sponsor's last update on 19 Sep 2025. 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?
Assessment of gastric volume with the aid of ultrasound (time frame: 3 hours postoperatively). 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 19 Sep 2025.