Comparative Study Between Intrathecal (Dexmedetomidine Versus Fentanyl)

NCT ID: NCT06970574

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-10
• Study Completion Date: 2023-07-10

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.

Conditions

Cholecystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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.

Group Type: ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type: 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.

Group B

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.

Group Type: ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type: 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.

Interventions

Levobupivacaine

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

Intervention Type: DRUG

Other Intervention Names

fentanyl 50 mcg/ml; Dextmedetomidine

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Nehal Samir Esmail

Lecturer of Anesthesia, intensive care and pain management Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed hamody Hassan, Assist. Prof.

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology, Intensive care, and Pain Management, Faculty of Medicine, Sohag University

Locations

Sohag University Hospital

Sohag, , Egypt

Countries

Egypt

Other Identifiers

laparoscopic cholecystectomies

Identifier Type: -

Identifier Source: org_study_id