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Comparative Study Between Intrathecal (Dexmedetomidine Versus Fentanyl)

Comparative Study Between Intrathecal (Dexmedetomidine Versus Fentanyl) in Laparoscopic Cholecystectomies Under Spinal Anesthesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06970574
Enrollment
60
Registered
2025-05-14
Start date
2022-07-10
Completion date
2023-07-10
Last updated
2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystitis

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.

Interventions

DRUGLevobupivacaine

to compare the clinical intraoperative effects of intrathecal administration of fentanyl in comparison with dexmedetomidine on shoulder tip pain in patients undergoing laparoscopic cholecystectomy.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Effect of pneumoperitonum to shoulder painfrom 0 hours to 6 hours after the procedureAssessment 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026