Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block

NCT06216197 | Completed

• 1 other identifier: 0395/2023
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Dexmedetomidine is recommended over fentanyl as adjunctive medication to bupivacaine for saddle block spinal anesthesia in anal surgeries and procedures.

Conditions

Regional Anesthesia Morbidity

Outcome Measures

Primary Outcomes (1)

• the duration until the first call for analgesia

  the duration until the first call for analgesia

  20 months

Secondary Outcomes (5)

• the duration from spinal injection until reaching the maximal sensory level

  20 months

• the duration needed for sensory regression to occur over two spinal segments from the maximal sensory level

  20 months

• the time required for sensory regression until reaching the S1 level (from the maximal sensory level)

  20 months

• the duration from injection to achieving Bromage 0, the total tramadol consumption (until the first 24 hours)

  20 months

• side effects occurrences

  20 months

Study Arms (2)

The FENT Group

OTHER

Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg).

Drug: FENT group

The DEX Group

OTHER

The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).

Drug: DEX group

Interventions

FENT group DRUG

Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg).

Also known as: fentanyl group

The FENT Group

DEX group DRUG

The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).

Also known as: dexmedetomidine group

The DEX Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• both sexes
• aged between 20 and 60
• classified as II \& ASA-I
• scheduled for elective anal surgeries

You may not qualify if:

• subjects who refused to participate
• uncontrolled hypertension
• BMI \> 30 kg/m2
• heart failure (class IV or III) based on the New York Heart Association (NYHA)
• uncorrected coagulopathy
• any study's drug allergy
• drug abuse
• neuropathy
• any spinal anesthesia contraindication (such as infection or a pelvic fracture)

Sponsors & Collaborators

• Zulekha Hospitals: lead

Study Sites (1)

Al-Azhar faculty of medicine

Cairo, 12546, Egypt

Location

Study Officials

• sameh ha seyam, MD

  assistant professor of anesthesiology, intensive care and pain management

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The subjects were randomly categorized into two groups utilizing random numbers generated by computer software. A sealed envelope (containing the allocation numbers of groups) was opened at the time of patient enrollment.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Fifty-eight adult patients were categorized into two groups. Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg). The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 22, 2024
• Study Start: April 3, 2021
• Primary Completion: December 4, 2022
• Study Completion: December 4, 2022
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)