Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection
The Effect of Intrathecal Versus Intravenous Dexmedetomidine on Postoperative Analgesia in Transurethral Resection of The Prostate
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Laila Elahwal, MD
- Telefonnummer: +20 1018484319
- E-post: Lailaelahwal@gmail.com
Studiesteder
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ElGharbia
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Tanta, ElGharbia, Egypt, 31511
- Rekruttering
- Surgical Intensive Care and Pain Medicine Department, Faculty of Medicine, Tanta University, Tanta, Egypt
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Ta kontakt med:
- Laila Elahwal, MD
- Telefonnummer: +20 1018484319
- E-post: Lailaelahwal@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Control group
Cases will be subjected to spinal anesthesia with hyperbaric bupivacaine 10 mg.
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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.
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Eksperimentell: Intrathecal group
Cases will be subjected to the same anesthetic mixture as controls with adding dexmedetomidine 5 μg.
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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.
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Eksperimentell: 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).
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Time to first analgesic request
Tidsramme: 24 hours postoperatively
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Time to first analgesic request will be recorded
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24 hours postoperatively
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The onset of sensory
Tidsramme: 24 hours Postoperatively
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Time to reach T7 sensory block will be recorded
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24 hours Postoperatively
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The degree of motor block
Tidsramme: 24 hours Postoperatively
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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.
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24 hours Postoperatively
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Sedation level
Tidsramme: Intraoperativley
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Patients level of sedation will be assessed via Ramsay sedation score.
This score is numbered from 1 to 6, based on patient responsiveness.
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Intraoperativley
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Total analgesic requirements
Tidsramme: 48 hours Postoperatively
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Total analgesic requirements will be recorded
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48 hours Postoperatively
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The incidence of side effects
Tidsramme: 48 hours Postoperatively
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The incidence of side effects including (bradycardia, hypotension, nausea, vomiting, and pruritis) will be recorded..
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48 hours Postoperatively
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 34141/9/20
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
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