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

NCT ID: NCT05596552

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-15
• Study Completion Date: 2022-07-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Bupivacaine-Dexmedetomidine group

Group Type: ACTIVE_COMPARATOR

hyperbaric bupivacaine and dexmedetomidine

Intervention Type: 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-Fentanyl group

Group Type: ACTIVE_COMPARATOR

Bupivacaine-Fentanyl group

Intervention Type: 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

Interventions

hyperbaric bupivacaine and dexmedetomidine

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

Intervention Type: DRUG

Bupivacaine-Fentanyl group

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ghada M.Samir

Assistant Professor of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghada M Samir, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Ain- Shams University

Locations

Faculty of Medicine

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS532/2021

Identifier Type: -

Identifier Source: org_study_id