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临床试验/NCT07290504
NCT07290504招募中不适用

The Effect of Gradual Versus Intermittent Release of Tourniquet on Mean Arterial Blood Pressure in Hypertensive Patients Undergoing Upper Limb Orthopedic Surgeries: A Blinded Randomized Controlled Study

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年12月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
68
试验地点
1
主要终点
Mean Arterial Pressure

研究概览

简要总结

In this clinical trial, the authors will compare two tourniquet deflation techniques and their clinical implications on hemodynamics and acid base parameters in hypertensive orthopedic patients undergoing upper limb surgeries under general anesthesia.

详细描述

General anesthesia will be induced using an injection of 1-1.5 mg/kg of propofol, 1-2 mic/kg of fentanyl, and 0.5 mg/kg of atracurium,with all doses to be titrated. An endotracheal tube will be inserted after 3 minutes of mask ventilation.

Anesthesia will be maintained using isoflurane (1%) and atracurium at a dosage of 0.1mg\kg every 20 minutes.

After endotracheal intubation, the patients will be mechanically ventilated with a 50% oxygen-air mixture, utilizing a tidal volume of 8 mL/kg based on ideal body weight at an inspiratory rate of 10-14 breaths per minute. Adjustments will be made to ensure that the end-tidal CO2 partial pressure (ETCO2) between 35 and 40 mmHg, with peak airway pressure kept below 30 mmHg.

The surgeon will start limb elevation, exsanguinating of blood and applying a double- cuffed tourniquet(zimmer A.T.S.3000) at the middle of the arm over cotton padding,with pressure ranging 200 mmHg according to the patient's blood pressure (50mmHg above systolic blood pressure).

After completion of surgical procedure,tourniquet deflation will be performed by anesthesia technician blinded to the study groups into two ways according to the randomization number received in closed envelop with the patient file and blinded from the research anesthiologist: in gradual group (G group) deflation by rate 50mmHg/ 30s untill complete release within 3 minutes .In intermittent group (I group) complete deflation will occur for 10 seconds, then reinflated for 50 seconds, repeating this cycle three times until complete release. If the surgery exceeded 2 hr, the intermittent technique for deflation will be used The researcher anesthesiologist who collects data, including hemodynamics and labs will be separated from the upper limb, tourniquet device, and the technician by surgical curtain to ensure full blinding of the deflation technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

After completion of surgical procedure, tourniquet deflation will be performed by anesthesia technician into two ways according to the randomization number received in closed envelop with the patient file and blinded from the research anesthiologist: in gradual group (Ggroup) deflation by rate 50mmHg/ 30s untill complete release within 3 minutes .In intermittent group (Igroup) complete deflation will occur for 10 seconds, then reinflated for 50 seconds, repeating this cycle three times until complete release.The researcher anesthesiologist who collects data, including hemodynamics and labs will be separated from the upper limb, tourniquet device, and the technician by surgical curtain to ensure full blinding of the deflation technique.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hypertensive patients (controlled on medical treatment more than three months)
  • Patients scheduled for upper limb orthopedic surgeries using a tourniquet for at least 30 min.
  • BMI from 18.5 to 29.9

排除标准

  • Patient refusal
  • ASA physical status > II
  • Multiple orthopedic surgeries
  • Emergency surgeries
  • Patient with relative contraindications for tourniquet use

研究组 & 干预措施

G group

Experimental

Gradual group (G group) deflation by rate 50mmHg/ 30s until complete release within 3 minutes

干预措施: Tourniquet deflation (Device)

I group

Active Comparator

Intermittent group (I group) complete deflation will occur for 10 seconds, then reinflated for 50 seconds, repeating this cycle three times until complete release.

干预措施: Tourniquet deflation (Device)

结局指标

主要结局

Mean Arterial Pressure

时间窗: 5 minutes

The decrease in MAP (more than 25% compared to baseline) 5 minues after deflation.

次要结局

  • Acid base status(5 minutes)
  • Lactate(30 minutes)
  • Potassium level(30 minutes)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Khaled Abdelfattah Abdallah Sarhan

principal investigator, Associate professor of anesthesia, Cairo university

Kasr El Aini Hospital

研究点 (1)

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