Comparison of Intrathecal Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine on Post-operative Urinary Retention in Knee Joint Arthroscopic Surgeries

NCT05596552 | Completed Phase 4

• 1 other identifier: MS532/2021
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to assess the effect of intrathecally injected 5 µg dexmedetomidine or 25 µg fentanyl as adjuvants to bupivacaine in low dose spinal anesthesia for unilateral arthroscopic knee surgeries, on post-operative urinary retention (POUR), time needed to reach sensory block at the tenth thoracic dermatome (T10), the maximum sensory level achieved, the onset of motor block, the intra-operative fluids given, the duration of sensory and motor blocks, time to micturition or insertion of an intermittent urinary catheter and the number of patients who needed an indwelling (Foley's) catheter. Seventy patients, ASA physical status I or II, from 21 to 50 years old, scheduled to undergo unilateral arthroscopic knee surgeries under spinal anesthesia, were randomly divided into two equal groups; the Bupivacaine- Dexmedetomidine group (BD) patients and the Bupivacaine-Fentanyl group (BF) patients.

Conditions

Post-Op Complication

Outcome Measures

Primary Outcomes (1)

• Post-operative urinary retention

  Ultrasound assessment of the urinary bladder volume was done at the 3rd post-operative hour, a bladder volume of \>700 ml with no ability to void confirmed the presence of urinary retention

  3 hours

Secondary Outcomes (8)

• Time to reach sensory block at T10

  30 minutes

• Maximum sensory level achieved

  30 minutes

• The onset of motor block

  30 minutes

• Intra-operative fluids given

  3 hours

• Duration of sensory block

  6 hours

Study Arms (2)

Bupivacaine-Dexmedetomidine group

ACTIVE COMPARATOR

Drug: hyperbaric bupivacaine and dexmedetomidine

Bupivacaine-Fentanyl group

ACTIVE COMPARATOR

Drug: Bupivacaine-Fentanyl group

Interventions

hyperbaric bupivacaine and dexmedetomidine DRUG

In a 3 ml syringe, 5 µg dexmedetomidine was added to the 2 ml of 10 mg hyperbaric bupivacaine, to have a total volume of 2.5 ml for intrathecal spinal injection over 3 minute without barbotage

Bupivacaine-Dexmedetomidine group

Bupivacaine-Fentanyl group DRUG

In a 3 ml syringe, 25 μg fentanyl was added to the 2 ml of 10 mg hyperbaric bupivacaine, to have a total volume of 2.5 ml for intrathecal spinal injection over 3 minute without barbotage

Bupivacaine-Fentanyl group

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I and II
• aged 21-50 years
• scheduled to undergo unilateral arthroscopic knee surgeries under spinal anesthesia

You may not qualify if:

• Patients' refusal
• contraindications to spinal anesthesia
• patients with coagulopathy
• infection at the lumbar region
• pre-existing neurological deficits in the lower limbs
• known allergy to any of the study drugs
• urinary incontinence
• cysto-ureteric reflux
• patients with congestive heart failure
• patients with dysrhythmia
• patients with heart block
• diabetic patients
• patients on α2-adrenergic receptors antagonists
• calcium channel blockers

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine

Cairo, Egypt

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ghada M Samir, MD

  Faculty of Medicine, Ain- Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: October 15, 2021
• Primary Completion: May 25, 2022
• Study Completion: July 15, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

EG (1)