Laparoscopic Cholecystectomy SurgeryPhase 4NCT07425444
Attenuate the Stress Response in Laparoscopic Cholecystectomy
A Phase 4 study testing Dexmedetomidine and Fentanyl- midazolam in people with Laparoscopic Cholecystectomy Surgery, run by Assiut University.
Trial summary
Aims of this study are to compare the effectiveness of dexmedetomidine versus fentanyl-midazolam in attenuating hemodynamic stress response during laparoscopic cholecystectomy (mainly HR). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy Surgery
- What is being tested?
- Dexmedetomidine and Fentanyl- midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Apr 2027
- Phase
- Phase 4
- 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.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I - II.
Who cannot join
- Known allergy to study drugs.
- Uncontrolled, non-correctable comorbidities (hepatic, renal or cardiac such as hypertension \& Arrhythmia ).
- History of psychiatric illness or substance abuse.
- Pregnancy or lactation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dexmedetomidine Versus Fentanyl-Midazolam Combination to Attenuate the Stress Response in Laparoscopic Cholecystectomy
Aims of this study are to compare the effectiveness of dexmedetomidine versus fentanyl-midazolam in attenuating hemodynamic stress response during laparoscopic cholecystectomy (mainly HR). And to assess the recovery profile, the pain and opioid requirements, the sedation profile, and any adverse events during the first 24 hrs postoperatively
Read the detailed description
Induction of general anesthesia, direct laryngoscopy and tracheal intubation induce marked cardiovascular changes as well as autonomic reflex activity. Although the responses of blood pressure and heart rate are short lived, they might have detrimental effects in high-risk patients, especially those with cardiovascular disease (1). These cardiovascular responses are associated with increased plasma levels of catecholamines (2). The main reason for the intubation induced hypertension seems to be a release of noradrenaline and, to a lesser extent, of adrenaline. In addition, increased levels of adrenocorticotrophic hormone (ACTH) and dopamine have also been reported (3).
A variety of factors have been shown to have an effect on this stress response: the choice and dosages of premedication and induction agents (4), the skill of the operator, and probably the technique being used. Numerous studies have demonstrated an increased stress response during direct laryngoscopy, fibreoptic intubation and insertion of the laryngeal mask (5).
- Dexmedetomidine is an Alpha 2 adrenoreceptors agonists may exert its analgesic effect through hyperpolarization of the non-adrenergic neurons which leads to depression of neuronal firing in the locus ceruleous together with suppression of the release of norepinephrine because of the stimulation of the central adrenergic receptors which produces a hypnotic effect without ventilatory depression (6).
- Midazolam is the benzodiazepine with the shortest half-life. It produces sedation and amnesia by acting on the γ-aminobutyric acid type-A receptors; additionally, its combined application in peripheral nerve blocks can increase the convulsive threshold of local anesthetics. It should be noted that GABA enhanced in amplitude by midazolam resulting in inhabitation of projection neurons and antinociception (7).
Fentanyl citrate is an opioid strong analgesic that is particularly well suited for use in anesthesia because of its high potency, rapid onset and short duration of action, absence of emetic activity, and minimal hypotensive activity after intravenous administration. As with other morphine-like analgesics. (8).
Laparoscopic cholecystectomy has increasingly been accepted as the procedure of choice for treatment of symptomatic gallstones and chronic cholecystitis (9). Its role and its timing in the management of acute cholecystitis, however remain controversial. The potential hazard of severe complications as a result of distorted anatomy caused by acute inflammation is a major concern (10)
- Conditions
- Laparoscopic Cholecystectomy Surgery
- Being tested
- Dexmedetomidine, Fentanyl- midazolam
- Keywords
- stress response
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
investigator will give Loading dose 1 mcg/kg IV over 10 min, followed by infusion 0.5 mcg/kg/h until pneumoperitoneum established
Fentanyl- midazolamDrug
Investigator will inject Fentanyl 2 mcg/kg IV + Midazolam 0.05 mg/kg IV before induction.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Experimental | Not described Receives: Drug: Dexmedetomidine |
| Fentanyl-Midazolam Group | Active comparator | Not described Receives: Drug: Fentanyl- midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamics
Hemodynamics mainly HR
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Cholecystectomy SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anas Ahmed Abd Elmoaty, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425444
- Sponsor's protocol ID
- stress in lap cholecystectomy
- Status last verified
- Dec 2025
- First submitted
- 7 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kum CK, Goh PM, Isaac JR, Tekant Y, Ngoi SS. Laparoscopic cholecystectomy for acute cholecystitis. Br J Surg. 1994 Nov;81(11):1651-4. doi: 10.1002/bjs.1800811130.
PubMed 7827896Bass EB, Pitt HA, Lillemoe KD. Cost-effectiveness of laparoscopic cholecystectomy versus open cholecystectomy. Am J Surg. 1993 Apr;165(4):466-71. doi: 10.1016/s0002-9610(05)80942-0.
PubMed 8480883GARDOCKI JF, YELNOSKY J. A STUDY OF SOME OF THE PHARMACOLOGIC ACTIONS OF FENTANYL CITRATE. Toxicol Appl Pharmacol. 1964 Jan;6:48-62. doi: 10.1016/0041-008x(64)90021-3. No abstract available.
PubMed 14105897Kohno T, Kumamoto E, Baba H, Ataka T, Okamoto M, Shimoji K, Yoshimura M. Actions of midazolam on GABAergic transmission in substantia gelatinosa neurons of adult rat spinal cord slices. Anesthesiology. 2000 Feb;92(2):507-15. doi: 10.1097/00000542-200002000-00034.
PubMed 10691239Kosugi T, Mizuta K, Fujita T, Nakashima M, Kumamoto E. High concentrations of dexmedetomidine inhibit compound action potentials in frog sciatic nerves without alpha(2) adrenoceptor activation. Br J Pharmacol. 2010 Aug;160(7):1662-76. doi: 10.1111/j.1476-5381.2010.00833.x.
PubMed 20649570Smith JE, King MJ, Yanny HF, Pottinger KA, Pomirska MB. Effect of fentanyl on the circulatory responses to orotracheal fibreoptic intubation. Anaesthesia. 1992 Jan;47(1):20-3. doi: 10.1111/j.1365-2044.1992.tb01946.x.
PubMed 1536396Bucx MJ, van Geel RT, Scheck PA, Stijnen T. Cardiovascular effects of forces applied during laryngoscopy. The importance of tracheal intubation. Anaesthesia. 1992 Dec;47(12):1029-33. doi: 10.1111/j.1365-2044.1992.tb04195.x.
PubMed 1489023Weatherill D, Spence AA. Anaesthesia and disorders of the adrenal cortex. Br J Anaesth. 1984 Jul;56(7):741-9. doi: 10.1093/bja/56.7.741. No abstract available.
PubMed 6375706Derbyshire DR, Chmielewski A, Fell D, Vater M, Achola K, Smith G. Plasma catecholamine responses to tracheal intubation. Br J Anaesth. 1983 Sep;55(9):855-60. doi: 10.1093/bja/55.9.855.
PubMed 6615672Siedlecki J. Disturbances in the function of cardiovascular system in patients following endotracheal intubation and attempts of their prevention by pharmacological bloackade of sympathetic system. Anaesth Resusc Intensive Ther. 1975 Apr-Jun;3(2):107-23.
PubMed 1180371
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Fentanyl-Midazolam Combination to Attenuate the Stress Response in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07425444
- Acronym / sponsor ID
- stress in lap cholecystectomy
- Conditions
- Laparoscopic Cholecystectomy Surgery
- Keywords
- stress response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 20 Feb 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.
Aims of this study are to compare the effectiveness of dexmedetomidine versus fentanyl-midazolam in attenuating hemodynamic stress response during laparoscopic cholecystectomy (mainly HR). And to assess the recovery profile, the pain and opioid requirements, the sedation profile, and any adverse events during the first 24 hrs postoperatively
Detailed description
Induction of general anesthesia, direct laryngoscopy and tracheal intubation induce marked cardiovascular changes as well as autonomic reflex activity. Although the responses of blood pressure and heart rate are short lived, they might have detrimental effects in high-risk patients, especially those with cardiovascular disease (1). These cardiovascular responses are associated with increased plasma levels of catecholamines (2). The main reason for the intubation induced hypertension seems to be a release of noradrenaline and, to a lesser extent, of adrenaline. In addition, increased levels of adrenocorticotrophic hormone (ACTH) and dopamine have also been reported (3).
A variety of factors have been shown to have an effect on this stress response: the choice and dosages of premedication and induction agents (4), the skill of the operator, and probably the technique being used. Numerous studies have demonstrated an increased stress response during direct laryngoscopy, fibreoptic intubation and insertion of the laryngeal mask (5).
- Dexmedetomidine is an Alpha 2 adrenoreceptors agonists may exert its analgesic effect through hyperpolarization of the non-adrenergic neurons which leads to depression of neuronal firing in the locus ceruleous together with suppression of the release of norepinephrine because of the stimulation of the central adrenergic receptors which produces a hypnotic effect without ventilatory depression (6).
- Midazolam is the benzodiazepine with the shortest half-life. It produces sedation and amnesia by acting on the γ-aminobutyric acid type-A receptors; additionally, its combined application in peripheral nerve blocks can increase the convulsive threshold of local anesthetics. It should be noted that GABA enhanced in amplitude by midazolam resulting in inhabitation of projection neurons and antinociception (7).
Fentanyl citrate is an opioid strong analgesic that is particularly well suited for use in anesthesia because of its high potency, rapid onset and short duration of action, absence of emetic activity, and minimal hypotensive activity after intravenous administration. As with other morphine-like analgesics. (8).
Laparoscopic cholecystectomy has increasingly been accepted as the procedure of choice for treatment of symptomatic gallstones and chronic cholecystitis (9). Its role and its timing in the management of acute cholecystitis, however remain controversial. The potential hazard of severe complications as a result of distorted anatomy caused by acute inflammation is a major concern (10)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Experimental | Drug: Dexmedetomidine |
| Fentanyl-Midazolam Group | Active comparator | Drug: Fentanyl- midazolam |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I - II.
Key exclusion criteria (4 listed)
- Known allergy to study drugs.
- Uncontrolled, non-correctable comorbidities (hepatic, renal or cardiac such as hypertension \& Arrhythmia ).
- History of psychiatric illness or substance abuse.
- Pregnancy or lactation
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 |
|---|---|---|
| Dexmedetomidineinvestigator will give Loading dose 1 mcg/kg IV over 10 min, followed by infusion 0.5 mcg/kg/h until pneumoperitoneum established | Drug | Dexmedetomidine Group |
| Fentanyl- midazolamInvestigator will inject Fentanyl 2 mcg/kg IV + Midazolam 0.05 mg/kg IV before induction. | Drug | Fentanyl-Midazolam Group |
Primary outcome
Hemodynamics
Time frame: During procedure
Hemodynamics mainly HR
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 Feb 2026.
- Results publication: PubMed 7827896Kum CK, Goh PM, Isaac JR, Tekant Y, Ngoi SS. Laparoscopic cholecystectomy for acute cholecystitis. Br J Surg. 1994 Nov;81(11):1651-4. doi: 10.1002/bjs.1800811130.
- Results publication: PubMed 8480883Bass EB, Pitt HA, Lillemoe KD. Cost-effectiveness of laparoscopic cholecystectomy versus open cholecystectomy. Am J Surg. 1993 Apr;165(4):466-71. doi: 10.1016/s0002-9610(05)80942-0.
- Results publication: PubMed 14105897GARDOCKI JF, YELNOSKY J. A STUDY OF SOME OF THE PHARMACOLOGIC ACTIONS OF FENTANYL CITRATE. Toxicol Appl Pharmacol. 1964 Jan;6:48-62. doi: 10.1016/0041-008x(64)90021-3. No abstract available.
- Results publication: PubMed 10691239Kohno T, Kumamoto E, Baba H, Ataka T, Okamoto M, Shimoji K, Yoshimura M. Actions of midazolam on GABAergic transmission in substantia gelatinosa neurons of adult rat spinal cord slices. Anesthesiology. 2000 Feb;92(2):507-15. doi: 10.1097/00000542-200002000-00034.
- Results publication: PubMed 20649570Kosugi T, Mizuta K, Fujita T, Nakashima M, Kumamoto E. High concentrations of dexmedetomidine inhibit compound action potentials in frog sciatic nerves without alpha(2) adrenoceptor activation. Br J Pharmacol. 2010 Aug;160(7):1662-76. doi: 10.1111/j.1476-5381.2010.00833.x.
- Results publication: PubMed 1536396Smith JE, King MJ, Yanny HF, Pottinger KA, Pomirska MB. Effect of fentanyl on the circulatory responses to orotracheal fibreoptic intubation. Anaesthesia. 1992 Jan;47(1):20-3. doi: 10.1111/j.1365-2044.1992.tb01946.x.
- Results publication: PubMed 1489023Bucx MJ, van Geel RT, Scheck PA, Stijnen T. Cardiovascular effects of forces applied during laryngoscopy. The importance of tracheal intubation. Anaesthesia. 1992 Dec;47(12):1029-33. doi: 10.1111/j.1365-2044.1992.tb04195.x.
- Results publication: PubMed 6375706Weatherill D, Spence AA. Anaesthesia and disorders of the adrenal cortex. Br J Anaesth. 1984 Jul;56(7):741-9. doi: 10.1093/bja/56.7.741. No abstract available.
- Results publication: PubMed 6615672Derbyshire DR, Chmielewski A, Fell D, Vater M, Achola K, Smith G. Plasma catecholamine responses to tracheal intubation. Br J Anaesth. 1983 Sep;55(9):855-60. doi: 10.1093/bja/55.9.855.
- Results publication: PubMed 1180371Siedlecki J. Disturbances in the function of cardiovascular system in patients following endotracheal intubation and attempts of their prevention by pharmacological bloackade of sympathetic system. Anaesth Resusc Intensive Ther. 1975 Apr-Jun;3(2):107-23.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Fentanyl- midazolam in people with Laparoscopic Cholecystectomy Surgery, run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Anas Ahmed Abd elmoaty, resident doctor (+201006318654, anasa1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamics (time frame: During procedure). 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 NCT07425444, which also lists 10 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 20 Feb 2026.