Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05525819
• Other study ID #: 34141/9/20
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: April 29, 2023

Study information

• Verified date: September 2022
• Source: Tanta University
• Contact: Laila Elahwal, MD
• Phone: 1018484319
• Email: Lailaelahwal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: April 29, 2023
• Est. primary completion date: April 29, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Dexmedetomidine
• Transurethral Resection of Prostate

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Surgical Intensive Care and Pain Medicine Department, Faculty of Medicine, Tanta University, Tanta, Egypt	Tanta	ElGharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first analgesic request	Time to first analgesic request will be recorded	24 hours postoperatively
Secondary	The onset of sensory	Time to reach T7 sensory block will be recorded	24 hours Postoperatively
Secondary	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
Secondary	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
Secondary	Total analgesic requirements	Total analgesic requirements will be recorded	48 hours Postoperatively
Secondary	The incidence of side effects	The incidence of side effects including (bradycardia, hypotension, nausea, vomiting, and pruritis) will be recorded..	48 hours Postoperatively