Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection

NCT05525819 | Unknown

• 1 other identifier: 34141/9/20
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to compare the effects of intrathecal versus intravenous dexmedetomidine administration in patients undergoing Transurethral resection of the prostate under spinal anesthesia.

Conditions

Dexmedetomidine; Transurethral Resection of Prostate; Analgesia

Outcome Measures

Primary Outcomes (1)

• Time to first analgesic request

  Time to first analgesic request will be recorded

  24 hours postoperatively

Secondary Outcomes (5)

• The onset of sensory

  24 hours Postoperatively

• The degree of motor block

  24 hours Postoperatively

• Sedation level

  Intraoperativley

• Total analgesic requirements

  48 hours Postoperatively

• The incidence of side effects

  48 hours Postoperatively

Study Arms (3)

Control group

EXPERIMENTAL

Cases will be subjected to spinal anesthesia with hyperbaric bupivacaine 10 mg.

Drug: Control group

Intrathecal group

EXPERIMENTAL

Cases will be subjected to the same anesthetic mixture as controls with adding dexmedetomidine 5 μg.

Drug: Intrathecal group

Intravenous group

EXPERIMENTAL

Cases will receive hyperbaric bupivacaine (10 mg), in addition to IV dexmedetomidine (1 μg/kg loading dose, followed by 0.4 μg/kg/h maintenance dose).

Drug: Intravenous group

Interventions

Control group DRUG

The cases will be subjected to spinal anesthesia with a 3 ml volume (2.5 ml of hyperbaric bupivacaine 10 mg in addition to 0.5 normal saline). 50 ml of normal saline was infused over a ten-minute period, followed by 200 ml infusion till the end of operation.

Control group

Intrathecal group DRUG

The cases will be subjected to the same anesthetic mixture as controls with adding dexmedetomidine 5 μg in the saline component. 50 ml of normal saline was infused over a ten-minute period, followed by 200 ml infusion till the end of operation.

Intrathecal group

Intravenous group DRUG

The intravenous group will receive 2.5 ml of hyperbaric bupivacaine (10 mg), in addition to intravenous dexmedetomidine, which will be started at 1 μg/kg loading dose diluted in 50 ml saline administered within 10 min, followed by maintenance at a 0.4 μg/kg/h dose diluted in 200 ml saline till the end of the procedure.

Intravenous group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cases aged between 50 and 70 years
• Having class I or II according to the American society of anesthesiologists (ASA)

You may not qualify if:

• Cases with heart block
• Dysrhythmia
• Contraindications for spinal anesthesia
• Known allergy to the study medications
• Classified as ASA class \> II
• Alpha 2 agonist or antagonist therapy.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Surgical Intensive Care and Pain Medicine Department, Faculty of Medicine, Tanta University, Tanta, Egypt

Tanta, ElGharbia, 31511, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Laila Elahwal, MD

CONTACT

1018484319; Lailaelahwal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 2, 2022
• Study Start: September 1, 2022
• Primary Completion: April 29, 2023
• Study Completion: April 29, 2023
• Last Updated: September 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the completion of the study

Locations

EG (1)