Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity

NCT07276867 | Recruiting

• 1 other identifier: AP2509-501-125-203
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The current work evaluated whether the combination of intrathecal dexmedetomidine and fentanyl provides superior postoperative analgesia to fentanyl alone when administered with hyperbaric bupivacaine.

Conditions

Fentanyl; Bupivacaine; Spinal Anesthesia; Above Knee Amputation; Intrathecal; Dexmedetomidine; Sarcomas; Lower Extremity

Outcome Measures

Primary Outcomes (1)

• Time to first rescue analgesia

  Time to first rescue analgesia (time from the end of surgery till the first dose of morphine is administered).

  24 hours postoperatively

Secondary Outcomes (4)

• Total amount of morphine

  24 hours postoperatively

• Intraoperative fentanyl consumption

  Intraoperatively

• Degree of pain

  24 hours postoperatively

• Incidence of adverse events

  24 hours postoperatively

Study Arms (2)

Group DF

EXPERIMENTAL

Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl + 5 µg dexmedetomidine.

Drug: Fentanyl + Dexmedetomidine

Group F

ACTIVE COMPARATOR

Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl.

Drug: Fentanyl

Interventions

Fentanyl + Dexmedetomidine DRUG

Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl + 5 µg dexmedetomidine.

Group DF

Fentanyl DRUG

Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl.

Group F

Eligibility Criteria

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

You may qualify if:

• Age from 18 to 60 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status of II-III.
• Height between 150-185 cm.
• Body mass index between 18-35 kg/m².
• Scheduled for above-knee amputation due to lower limb sarcomas.

You may not qualify if:

• Allergy to any of the investigated drugs.
• History of heart block, arrhythmia, or ongoing therapy with beta- or calcium channel- blockers, or angiotensin-converting-enzyme inhibitors.
• Contraindications to spinal anesthesia.
• Pregnancy or lactation.
• Presence of psychiatric illness or chronic pain conditions.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Fentanyl; Dexmedetomidine

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Central Study Contacts

Mai M Elrawas, MD

CONTACT

00201222177242; mai.elrawas@nci.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anaesthesia, Intensive Care and Pain Management, National Cancer Institute, Cairo University Cairo University, Cairo, Egypt.

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: October 20, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)