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Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05525819
Enrollment
75
Registered
2022-09-02
Start date
2022-09-01
Completion date
2023-04-29
Last updated
2022-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Dexmedetomidine, Transurethral Resection of Prostate

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.

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.

Interventions

DRUGControl 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.

DRUGIntrathecal 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.

DRUGIntravenous 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.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
50 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to first analgesic request24 hours postoperativelyTime to first analgesic request will be recorded

Secondary

MeasureTime frameDescription
The onset of sensory24 hours PostoperativelyTime to reach T7 sensory block will be recorded
The degree of motor block24 hours PostoperativelyThe 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.
Sedation levelIntraoperativleyPatients level of sedation will be assessed via Ramsay sedation score. This score is numbered from 1 to 6, based on patient responsiveness.
Total analgesic requirements48 hours PostoperativelyTotal analgesic requirements will be recorded
The incidence of side effects48 hours PostoperativelyThe incidence of side effects including (bradycardia, hypotension, nausea, vomiting, and pruritis) will be recorded..

Countries

Egypt

Contacts

Primary ContactLaila Elahwal, MD
Lailaelahwal@gmail.com1018484319

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026