Comparative Study Between Intrathecal (Dexmedetomidine Versus Fentanyl)

NCT06970574 | Completed DMC

• 1 other identifier: laparoscopic cholecystectomies
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystitis

Outcome Measures

Primary Outcomes (1)

• 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.

  from 0 hours to 6 hours after the procedure

Study Arms (2)

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.

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.

Drug: Levobupivacaine

Interventions

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.

Also known as: fentanyl 50 mcg/ml, Dextmedetomidine

Group A; Group B

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

MeSH Terms

Conditions

Cholecystitis

Interventions

Levobupivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ahmed hamody Hassan, Assist. Prof.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, intensive care and pain management Faculty of Medicine

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: July 10, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 10, 2023
• Last Updated: May 14, 2025

Record last verified: 2022-07

Locations

EG (1)