Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection
The Effect of Intrathecal Versus Intravenous Dexmedetomidine on Postoperative Analgesia in Transurethral Resection of The Prostate
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Laila Elahwal, MD
- 전화번호: +20 1018484319
- 이메일: Lailaelahwal@gmail.com
연구 장소
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ElGharbia
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Tanta, ElGharbia, 이집트, 31511
- 모병
- Surgical Intensive Care and Pain Medicine Department, Faculty of Medicine, Tanta University, Tanta, Egypt
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연락하다:
- Laila Elahwal, MD
- 전화번호: +20 1018484319
- 이메일: Lailaelahwal@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time to first analgesic request
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The onset of sensory
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 34141/9/20
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
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