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Completed

NCT Number: NCT06970574

Comparative Study Between Intrathecal (Dexmedetomidine Versus Fentanyl)

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.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University Hospital

Sohag, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levobupivacaine

Drug

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

Other names: fentanyl 50 mcg/ml, Dextmedetomidine

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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