CholecystitisNCT06970574
Comparative Study Between Intrathecal (Dexmedetomidine Versus Fentanyl)
A study testing Levobupivacaine in people with Cholecystitis, run by Sohag University at 1 site in Egypt.
Trial summary
Laparoscopy is one of the procedures of choice for most of the elective abdominal surgeries performed preferably under endotracheal general anesthesia. With the technical advances that have been made, laparoscopic cholecystectomy is considered a procedure with a good safety profile that offers advantages over open… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Cholecystitis
- What is being tested?
- Levobupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2022to 10 Jul 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 60 patients aged from 30 to 60 years of either sex with American Society of Anesthesiologists (ASA) grades I and II undergoing Elective laparoscopic cholecystectomies.
Who cannot join
- patients with ASA grade >II,
- Patients' refusal ,
- Patients using α2-adrenergic receptors antagonists, calcium channel blockers,
- angiotensin converting enzyme inhibitors ,
- Dysrhythmia ,
- Body weight more than 120 kg,
Show all 12Show fewer
- spinal deformity ,
- History of allergy to the study drugs ,
- Pregnancy ,
- Coagulopathy ,
- Neurological disorders
- known contraindications to spinal anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Intrathecal (Dexmedetomidine Versus Fentanyl) in Laparoscopic Cholecystectomies Under Spinal Anesthesia
Laparoscopy is one of the procedures of choice for most of the elective abdominal surgeries performed preferably under endotracheal general anesthesia. With the technical advances that have been made, laparoscopic cholecystectomy is considered a procedure with a good safety profile that offers advantages over open cholecystectomy.
Read the detailed description
Laparoscopy is one of the procedures of choice for most of the elective abdominal surgeries performed preferably under endotracheal general anesthesia. With the technical advances that have been made, laparoscopic cholecystectomy is considered a procedure with a good safety profile that offers advantages over open cholecystectomy.
In past general anesthesia is considered the only choice of anesthesia for laparoscopy, but nowadays regional anesthesia in the form of spinal anesthesia, epidural anesthesia and or combined spinal epidural provide beneficial advantages over general anesthesia.
The most limiting factor for use of spinal anesthesia in laparoscopy is patient's discomfort with pneumo-peritoneum and the associated shoulder tip pain.
Spinal anesthesia is the most popular technique for lower abdominal surgeries as it is very economical and easy to administer. Various adjuvants have been added to intra-thecal local anesthetic agents. as Intrathecal α2 agonists when used as adjuncts potentiate the effect of local anesthetics and allows a decrease in required doses of local anesthetics.
Clonidine is a partial α2 agonist used intrathecally with well-established efficacy and safety. It prolongs the duration of motor and sensory spinal blockade when used along with local anesthetics. .
Dexmedetomidine is new highly selective α2 adrenoceptor agonist and has been approved by Food and Drug Administration as intravenous (IV) sedative and co-analgesic drug. Its α2/α1 selectivity is 8 times higher than clonidine.
many studies have been conducted the effect of intrathecal dexmedetomidine when combined with levobupivacaine in spinal anesthesia. However, not much literature is available regarding the use of intrathecal dexmedetomitine with levobupivacaine to reduce shoulder tip pain in laparoscopic cholecystectomies.
- Conditions
- Cholecystitis
- Being tested
- Levobupivacaine
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called fentanyl 50 mcg/ml, Dextmedetomidine
to compare the clinical intraoperative effects of intrathecal administration of fentanyl in comparison with dexmedetomidine on shoulder tip pain in patients undergoing laparoscopic cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | About 30 patients received 3.0 ml of heavy levo-bupivacaine with10 µg fentanyl (0.5 ml) to make 3.5 ml . All patients had been examined a day before surgery and will be kept fasting over-night, and received atropine 0.2 mg and ondansetron 8 mg intra venous as premedication. In the operation theater, patient's baseline pulse, blood pressure (BP), saturation, ETCO2, respiratory rate (RR), and electrocardiography (ECG) will be recordedand all will be preloaded with ringer lactate 15 ml/kg. Receives: Drug: Levobupivacaine |
| Group B | Active comparator | About 30 patients received 3.0 ml of levo-bupivacaine along with dextmedetomidine 5 µg to make a total volume of 3.5 ml. All patients had been examined a day before surgery and will be kept fasting over-night, and received atropine 0.2 mg and ondansetron 8 mg intra venous as premedication. In the operation theater, patient's baseline pulse, blood pressure (BP), saturation, ETCO2, respiratory rate (RR), and electrocardiography (ECG) will be recordedand all will be preloaded with ringer lactate 15 ml/kg. Receives: Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of pneumoperitonum to shoulder pain
Assessment of Intraoperative complaints of shoulder tip pain after carbon dioxide insufflation, using four grades [0, no pain; 1, mild pain but no need for analgesic; 2, moderate pain and need for analgesic; 3, severe pain and no response to analgesics (need for conversion to general anesthesia)]. And the severity will be observed using the 10 visual analogue scale where 0 meant no pain and 10 meant worst pain experience.
Measured: from 0 hours to 6 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start10 Jul 2022
- Primary completion1 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- More trials run by Sohag 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Samir Esmail, Sohag University
- Investigators
- Ahmed hamody Hassan, Assist. Prof., Principal investigator, Anesthesiology, Intensive care, and Pain Management, Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970574
- Sponsor's protocol ID
- laparoscopic cholecystectomies
- Status last verified
- Jul 2022
- First submitted
- 6 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Intrathecal (Dexmedetomidine Versus Fentanyl) in Laparoscopic Cholecystectomies Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT06970574
- Acronym / sponsor ID
- laparoscopic cholecystectomies
- Conditions
- Cholecystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Jul 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 14 May 2025 (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.
Laparoscopy is one of the procedures of choice for most of the elective abdominal surgeries performed preferably under endotracheal general anesthesia. With the technical advances that have been made, laparoscopic cholecystectomy is considered a procedure with a good safety profile that offers advantages over open cholecystectomy.
Detailed description
Laparoscopy is one of the procedures of choice for most of the elective abdominal surgeries performed preferably under endotracheal general anesthesia. With the technical advances that have been made, laparoscopic cholecystectomy is considered a procedure with a good safety profile that offers advantages over open cholecystectomy.
In past general anesthesia is considered the only choice of anesthesia for laparoscopy, but nowadays regional anesthesia in the form of spinal anesthesia, epidural anesthesia and or combined spinal epidural provide beneficial advantages over general anesthesia.
The most limiting factor for use of spinal anesthesia in laparoscopy is patient's discomfort with pneumo-peritoneum and the associated shoulder tip pain.
Spinal anesthesia is the most popular technique for lower abdominal surgeries as it is very economical and easy to administer. Various adjuvants have been added to intra-thecal local anesthetic agents. as Intrathecal α2 agonists when used as adjuncts potentiate the effect of local anesthetics and allows a decrease in required doses of local anesthetics.
Clonidine is a partial α2 agonist used intrathecally with well-established efficacy and safety. It prolongs the duration of motor and sensory spinal blockade when used along with local anesthetics. .
Dexmedetomidine is new highly selective α2 adrenoceptor agonist and has been approved by Food and Drug Administration as intravenous (IV) sedative and co-analgesic drug. Its α2/α1 selectivity is 8 times higher than clonidine.
many studies have been conducted the effect of intrathecal dexmedetomidine when combined with levobupivacaine in spinal anesthesia. However, not much literature is available regarding the use of intrathecal dexmedetomitine with levobupivacaine to reduce shoulder tip pain in laparoscopic cholecystectomies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: LevobupivacaineAbout 30 patients received 3.0 ml of heavy levo-bupivacaine with10 µg fentanyl (0.5 ml) to make 3.5 ml . All patients had been examined a day before surgery and will be kept fasting over-night, and received atropine 0.2 mg and ondansetron 8 mg intra venous as premedication. In the operation theater, patient's baseline pulse, blood pressure (BP), saturation, ETCO2, respiratory rate (RR), and electrocardiography (ECG) will be recordedand all will be preloaded with ringer lactate 15 ml/kg. |
| Group B | Active comparator | Drug: LevobupivacaineAbout 30 patients received 3.0 ml of levo-bupivacaine along with dextmedetomidine 5 µg to make a total volume of 3.5 ml. All patients had been examined a day before surgery and will be kept fasting over-night, and received atropine 0.2 mg and ondansetron 8 mg intra venous as premedication. In the operation theater, patient's baseline pulse, blood pressure (BP), saturation, ETCO2, respiratory rate (RR), and electrocardiography (ECG) will be recordedand all will be preloaded with ringer lactate 15 ml/kg. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 60 patients aged from 30 to 60 years of either sex with American Society of Anesthesiologists (ASA) grades I and II undergoing Elective laparoscopic cholecystectomies.
Key exclusion criteria (12 listed)
- patients with ASA grade >II,
- Patients' refusal ,
- Patients using α2-adrenergic receptors antagonists, calcium channel blockers,
- angiotensin converting enzyme inhibitors ,
- Dysrhythmia ,
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 |
|---|---|---|
| LevobupivacaineAlso: fentanyl 50 mcg/ml, Dextmedetomidineto compare the clinical intraoperative effects of intrathecal administration of fentanyl in comparison with dexmedetomidine on shoulder tip pain in patients undergoing laparoscopic cholecystectomy. | Drug | Group A, Group B |
Primary outcome
Effect of pneumoperitonum to shoulder pain
Time frame: from 0 hours to 6 hours after the procedure
Assessment of Intraoperative complaints of shoulder tip pain after carbon dioxide insufflation, using four grades [0, no pain; 1, mild pain but no need for analgesic; 2, moderate pain and need for analgesic; 3, severe pain and no response to analgesics (need for conversion to general anesthesia)]. And the severity will be observed using the 10 visual analogue scale where 0 meant no pain and 10 meant worst pain experience.
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 14 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed hamody Hassan, Assist. Prof. principal investigator
Anesthesiology, Intensive care, and Pain Management, Faculty of Medicine, Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levobupivacaine in people with Cholecystitis, run by Sohag 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 1 inclusion and 12 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 14 May 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. 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?
Effect of pneumoperitonum to shoulder pain (time frame: from 0 hours to 6 hours after the procedure). 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 14 May 2025.