Clinical trial NCT06970574: Comparative Study Between Intrathecal (Dexmedetomidine Versus Fentanyl)
Official title: Comparative Study Between Intrathecal (Dexmedetomidine Versus Fentanyl) in Laparoscopic Cholecystectomies Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

- 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.

Exclusion Criteria:

* 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,
* spinal deformity ,
* History of allergy to the study drugs ,
* Pregnancy ,
* Coagulopathy ,
* Neurological disorders
* known contraindications to spinal anesthesia.

Primary outcomes:
measure: Effect of pneumoperitonum to shoulder pain
timeFrame: from 0 hours to 6 hours after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
affiliation: Anesthesiology, Intensive care, and Pain Management, Faculty of Medicine, Sohag University
name: Ahmed hamody Hassan, Assist. Prof.
role: PRINCIPAL_INVESTIGATOR
References: