Conventional Spinal Anaesthesia Versus Fractional Spinal Anaesthesia on Hemodynamics

NCT06583213 | Recruiting DMC

• 1 other identifier: FMASU MD76/2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

compare the systemic haemodynamic response to fractional spinal anaesthesia versus conventional spinal anaesthesia , in a group of elderly and comorbid patients with hip fracture.

Conditions

Hip Fractures

Keywords

fractional spinal

Outcome Measures

Primary Outcomes (1)

• Is to measure blood pressure change intra-operative operative operative (2 hours)

  blood pressure monitoring

  2 hours

Secondary Outcomes (1)

• Postoperative pain score for 24 hours

  within 24 hours

Study Arms (2)

Fractional Spinal Anaesthesia. Group A.

EXPERIMENTAL

An intrathecal catheter 20 G will be then inserted 4-5 cm into the intrathecal space.This technique of SA will be performed on all patients , the needle should be inserted between L3 and L4 space or L4 and L5 space in order to avoid injury to the spinal cord. An intrathecal mixture (5mL) containing 3 mg/ml hyperbaric bupivacaine and 1 μg/ml dexmedetomidine will be prepared. Intrathecal anaesthesia will be induced by giving 2 mL (6 mg of hyperbaric bupivacaine and 2 μg of dexmedetomidine ) of the mixture, followed by a second 2 mL injection after 25 min.

Procedure: Fractional Spinal Anaesthesia.; Procedure: Conventional Spinal Anaesthesia

Conventional Spinal Anaesthesia. Group B.

ACTIVE COMPARATOR

Intrathecal anaesthesia will be induced by giving 12.5 mg Hyperbaric bupivacaine (2.5mL) and 4 μg of dexmedetomidine (1mL) (i.e., a total intrathecal dose (3.5 mL) of 12.5mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ). Sensory level will be monitored by "cold spray". Haemodynamic recordings will be documented every five minutes up until 45 minutes.

Procedure: Fractional Spinal Anaesthesia.; Procedure: Conventional Spinal Anaesthesia

Interventions

Fractional Spinal Anaesthesia. PROCEDURE

An intrathecal catheter 20 G will be then inserted 4-5 cm into the intrathecal space.This technique of SA will be performed on all patients , the needle should be inserted between L3 and L4 space or L4 and L5 space in order to avoid injury to the spinal cord. An intrathecal mixture (5mL) containing 3 mg/ml hyperbaric bupivacaine and 1 μg/ml dexmedetomidine will be prepared. Intrathecal anaesthesia will be induced by giving 2 mL (6 mg of hyperbaric bupivacaine and 2 μg of dexmedetomidine ) of the mixture, followed by a second 2 mL injection after 25 min. (i.e., a total intrathecal dose (4mL) of 12 mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ).

Conventional Spinal Anaesthesia. Group B.; Fractional Spinal Anaesthesia. Group A.

Conventional Spinal Anaesthesia PROCEDURE

Intrathecal anaesthesia will be induced by giving 12.5 mg Hyperbaric bupivacaine (2.5mL) and 4 μg of dexmedetomidine (1mL) (i.e., a total intrathecal dose (3.5 mL) of 12.5mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ). (Mohamed T et al., 2017). Sensory level will be monitored by "cold spray". Haemodynamic recordings will be documented every five minutes up until 45 minutes.

Conventional Spinal Anaesthesia. Group B.; Fractional Spinal Anaesthesia. Group A.

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with hip fractures.
• Patients age \>60 years old.
• ASA ≤ 3.

You may not qualify if:

• Patients on anticoagulant medication.
• Planned for general anaesthesia .
• Patients had atrial fibrillation.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• ahmed saudi, professor

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

ahmed yousri, master

CONTACT

01141556766; ahmed.yousri@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: September 3, 2024
• Study Start: September 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 25, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)