NCT07114263

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

August 11, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

August 4, 2025

Last Update Submit

August 4, 2025

Conditions

Spinal Anesthesia AdministrationAnalgesicAnorectal Surgery

Keywords

anorectal surgeries.hyperbaric bupivacaineDexmedetomidineSpinal AnesthesiaSaddle Block

Outcome Measures

Primary Outcomes (1)

  • Duration of analgesia

    from time of spinal block to first demand of rescue analgesia

    2 hours

Secondary Outcomes (1)

  • Incidence of complications

    24 hours

Study Arms (3)

Group F :Fentanyl group

EXPERIMENTAL

Patients 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.

Drug: Group F (fentanyl group)

Group D: Dexmedetomidine group

EXPERIMENTAL

Patients 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.

Drug: Group D :Dexmedetomidine group

Group DF :Fentanyl and Dexmedetomidine

EXPERIMENTAL

Patients 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.

Drug: Group DF :Fentanyl and Dexmedetomidine group

Interventions

Group F (fentanyl group)DRUG

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 F :Fentanyl group
Group D :Dexmedetomidine groupDRUG

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 D: Dexmedetomidine group
Group DF :Fentanyl and Dexmedetomidine groupDRUG

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.

Group DF :Fentanyl and Dexmedetomidine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, Egypt

Location

Central Study Contacts

Ezzat Alhelw, Resident

CONTACT

+20 10 06489620ezzatnasr136@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Patients, anesthesia administrator, and outcome assessors will be blinded to the group allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start

August 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

August 11, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF

Locations

EG(1)