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Study of The Analgesic Profile of Two Adjuvants Added to Low Dose Hyperbaric Bupivacaine Versus One Adjuvant in Patients Undergoing Anal Surgery Using Spinal Anesthesia

NCT07114263 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-08
Last updated
2025-08-11

Condition(s) studied

Spinal Anesthesia AdministrationAnalgesicAnorectal Surgery

Investigational drug(s) / intervention(s)

Group F (fentanyl group)Group D :Dexmedetomidine groupGroup DF :Fentanyl and Dexmedetomidine group

Group F (fentanyl group): Group F (fentanyl group):will receive intrathecal 1.5 ml hyperbaric bupivacaine 0.5% and 0.5 ml (25 mcg) Fentanyl and 1 ml glucose 5% with total volume of 3ml.

Group D :Dexmedetomidine group: Group D :Dexmedetomidine group: will receive intrathecal 1.5 ml hyperbaric bupivacaine 0.5% and 1 ml (4 mcg) Dexmedetomidine and 0.5 ml glucose 5% with total volume of 3ml.

Group DF :Fentanyl and Dexmedetomidine group: Fentanyl and Dexmedetomidine group:will receive intrathecal 1.5 ml hyperbaric bupivacaine 0.5%, 0.5 ml (25 mcg) Fentanyl and 1 ml (4 mcg) Dexmedetomidine with total volume of 3ml.

Study summary

This study will be conducted to compare the efficacy of fentanyl and Dexmedetomidine as an additive to hyperbaric bupivacaine 0.5% in saddle block anesthesia on duration of analgesia in patients undergoing anorectal surgeries.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * aged from 18 to 65 years * American Society of Anesthesiologists' physical I or II of both sexes * Patients who will be scheduled to surgery for their uncomplicated hemorrhoids, anal fissure, or anal fistula in lithotomy position will be included in the study. Exclusion Criteria: * Infection focus at back, history of spine surgery, coagulopathy, mental disturbance, and neurological disease. * drug allergy. * intake of experimental or analgesic medication within last 24 hours. * patients receiving alpha-adrenergic antagonist will be excluded from the study.

Primary outcome measure(s)

  • Duration of analgesia — 2 hours
    from time of spinal block to first demand of rescue analgesia

Trial sites (1)

FacilityCityRegionStatus
Tanta University Tanta Gharbia Governorate
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07114263 on ClinicalTrials.gov ↗ ← All trials in Egypt