Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection

The Effect of Intrathecal Versus Intravenous Dexmedetomidine on Postoperative Analgesia in Transurethral Resection of The Prostate

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.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Dexmedetomidine; Transurethral Resection of Prostate
• Intervention / Treatment: Drug: Control group; Drug: Intrathecal group; Drug: Intravenous group

Detailed Description

Multiple prostatic pathologies become evident in the elderly males. Of them, benign prostatic hyperplasia is one of the most prevalent issues in aging men and transurethral resection of the prostate (TURP) still represents the standard surgical treatment.

Most transurethral resection of the prostate (TURP) procedures are performed under spinal anesthesia. Spinal anesthesia has many advantages including, easy application, low cost, decreasing the risk of aspiration, decreasing intraoperative bleeding, eliminating the need for mechanical ventilation together with the decreased risk of intraoperative cardiac events or post-operative hypoxic episode.

The management of post-operative pain following spinal anesthesia using a short-acting anesthetic still constitutes a major problem for anesthesiologists and pain physicians. However, the duration and efficacy of spinal anesthesia could be improved by adjuvants.

Dexmedetomidine is an alpha 2 receptor agonist that have antinociceptive action for both visceral and somatic pain. At low doses, it has sedative and hypnotic effects without having a negative impact on respiration. Multiple studies have reported that intrathecal and intravenous administration of this drug could prolong the duration of spinal anesthesia and post-operative analgesia.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laila Elahwal, MD; Phone Number: +20 1018484319; Email: Lailaelahwal@gmail.com

Study Locations

• Egypt
  • ElGharbia
    • Tanta, ElGharbia, Egypt, 31511
      • Recruiting
      • Surgical Intensive Care and Pain Medicine Department, Faculty of Medicine, Tanta University, Tanta, Egypt
      • Contact: Laila Elahwal, MD; Phone Number: +20 1018484319; Email: Lailaelahwal@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control group; Cases will be subjected to spinal anesthesia with hyperbaric bupivacaine 10 mg.	Drug: Control group; 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.
Experimental: Intrathecal group; Cases will be subjected to the same anesthetic mixture as controls with adding dexmedetomidine 5 μg.	Drug: Intrathecal group; 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.
Experimental: Intravenous group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first analgesic request	Time to first analgesic request will be recorded	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The onset of sensory	Time to reach T7 sensory block will be recorded	24 hours Postoperatively
The degree of motor block	The degree of motor block will be assessed using the modified Bromage Score. Grade 0 No motor block Grade 1 Inability to raise extended leg, able to move knees and feet Grade 2 Inability to raise extended leg and move knee, able to move feet Grade 3 Complete motor block of the lower limbs.	24 hours Postoperatively
Sedation level	Patients level of sedation will be assessed via Ramsay sedation score. This score is numbered from 1 to 6, based on patient responsiveness.	Intraoperativley
Total analgesic requirements	Total analgesic requirements will be recorded	48 hours Postoperatively
The incidence of side effects	The incidence of side effects including (bradycardia, hypotension, nausea, vomiting, and pruritis) will be recorded..	48 hours Postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): April 29, 2023
• Study Completion (Anticipated): April 29, 2023

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 34141/9/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All information will be available under a reasonable request from the corresponding author
• IPD Sharing Time Frame: One year after the completion of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No