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临床试验/NCT07033442
NCT07033442已完成不适用

Effects Of Inhalation Anaesthesia and Total Intravenous Anaesthesia on Intraocular Pressure in Robotic Prostate Surgery

Ataturk Training and Research Hospital0 个研究点目标入组 60 人开始时间: 2015年7月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
Intraocular Pressure Measured Using Tono-Pen at Multiple Perioperative Time Points (mmHg)

研究概览

简要总结

Robot-assisted surgery is now commonly used to treat prostate cancer. This type of surgery, called robot-assisted prostatectomy, helps doctors operate more precisely and allows patients to heal faster. But there are some special things to be careful about during these surgeries.

During the operation, the patient is placed in a steep head-down position for a long time. Staying in this position for a long period can cause the pressure inside the eyes-called intraocular pressure (IOP)-to go up. High eye pressure can be risky, especially for people who already have eye problems.

This study looked at different types of anesthesia used during robotic prostate surgery to see how they affect eye pressure. The goal was to find out which type of anesthesia causes less of an increase in eye pressure.

详细描述

In this study, the aim was to investigate the effects of hemodynamic changes induced by the steep Trendelenburg position and pneumoperitoneum, surgical duration, blood gas parameters, and the type of anesthesia administered on intraocular pressure (IOP) during robotic prostatectomy.

Prostate cancer is the most common type of cancer among men. Among the various treatment options, robot-assisted radical prostatectomy (RARP) stands out as the most recent and technologically advanced surgical approach.

This randomized and prospective study was conducted at the operating rooms of Ankara Atatürk Training and Research Hospital following approval by the Ethics Committee. Sixty cooperative adult male patients scheduled to undergo robotic prostatectomy under general anesthesia and classified as ASA physical status I-II were enrolled in the study after providing informed written consent.

Patients with severe cardiac disease, restrictive or obstructive pulmonary disease, renal or hepatic insufficiency, a history of hypersensitivity to anesthetic agents, psychiatric disorders, neurologic diseases, previous intracranial surgery, chronic alcohol, sedative, tranquilizer, or analgesic use, glaucoma, or those receiving medications known to affect IOP, as well as patients predicted to present with difficult intubation on direct laryngoscopy, were excluded from the study.

Participants were randomly assigned to one of two groups by drawing a label from a sealed envelope: Group 1 received inhalation anesthesia, and Group 2 received total intravenous anesthesia (TIVA). Demographic data were recorded. Prior to the induction of general anesthesia, while the participants were in the supine position, baseline measurements were taken, including heart rate (HR), mean arterial pressure (MAP), peripheral oxygen saturation (SpO₂), end-tidal CO₂ (ETCO₂), bispectral index (BIS), and IOP in both eyes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other

入排标准

性别
Male
接受健康志愿者

入选标准

  • Patients who will undergo robot-assisted prostate surgery with ASA I-II

排除标准

  • serious cardiac disease
  • restrictive and obstructive lung disease
  • renal and hepatic insufficiency
  • with a history of hypersensitivity to the agents to be used
  • with psychiatric disorders
  • with a history of neurological disease
  • who had intracranial surgery
  • with a history of alcohol, sedative, tranquilizer and long-term analgesic use,
  • with glaucoma and those taking medications that would affect IOP
  • who were thought to have difficult intubation during direct laryngoscopy.

研究组 & 干预措施

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: Sevoflurane (Volatile Anesthetic) (Drug)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: Remifentanil 2 MG (Drug)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: Rocuronium 50 mg/5 ml (Drug)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: Lidocaine %2 ampoule (Drug)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: Thiopental 500 mg vial for injection (Drug)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: Neostigmine 0,5 mg/ml ampoule (Drug)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: Atropine Sulphate 0.5mg/ml ampoule (Drug)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: Ephedrine Hydrochloride 0,05 mg/ml ampoule (Drug)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: CO₂ Pneumoperitoneum (Procedure)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: Bispectral index (BIS) Monitoring (Device)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: intraocular pressure measurement (Procedure)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: intraarterial cannulation and pressure measurement (Procedure)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: Mechanical Ventilation (Procedure)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: Peripheral Intravenous Cannulation (Procedure)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: Crystalloid solutions (Drug)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: Endotracheal Intubation (Procedure)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: American Society of Anesthesiologists (ASA) Standard Monitors (Procedure)

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

干预措施: Ventilatory Pressure and Compliance Monitoring (Procedure)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: Propofol 1% (Drug)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: Remifentanil 2 MG (Drug)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: Rocuronium 50 mg/5 ml (Drug)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: Lidocaine %2 ampoule (Drug)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: Neostigmine 0,5 mg/ml ampoule (Drug)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: Atropine Sulphate 0.5mg/ml ampoule (Drug)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: Ephedrine Hydrochloride 0,05 mg/ml ampoule (Drug)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: CO₂ Pneumoperitoneum (Procedure)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: Bispectral index (BIS) Monitoring (Device)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: intraocular pressure measurement (Procedure)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: intraarterial cannulation and pressure measurement (Procedure)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: Mechanical Ventilation (Procedure)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: Peripheral Intravenous Cannulation (Procedure)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: Crystalloid solutions (Drug)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: Endotracheal Intubation (Procedure)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: American Society of Anesthesiologists (ASA) Standard Monitors (Procedure)

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

干预措施: Ventilatory Pressure and Compliance Monitoring (Procedure)

结局指标

主要结局

Intraocular Pressure Measured Using Tono-Pen at Multiple Perioperative Time Points (mmHg)

时间窗: From 10 minutes before anesthesia induction to 45 minutes postoperatively

Intraocular pressure (IOP) will be measured in both eyes using a handheld Tono-Pen tonometer at the following predefined perioperative time points: T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after steep Trendelenburg positioning) T3 (2 minutes after carbon dioxide (CO₂) insufflation) T4 (1 hour after CO₂ insufflation) T5 (2 hours after CO₂ insufflation) T6 (3 hours after CO₂ insufflation) T7 (2 minutes after CO₂ desufflation) T8 (2 minutes after return to supine position) T9 (45 minutes postoperatively) The unit of measurement is mmHg at each time point. Each time point will be reported separately. To ensure consistency, all measurements will be performed by the same ophthalmologist.

次要结局

  • Heart Rate at Defined Perioperative Time Points (bpm)(From 10 minutes before anesthesia induction to 45 minutes postoperatively.)
  • Bispectral Index Score (BIS) Values at Defined Perioperative Time Points(From 10 minutes before anesthesia induction to 45 minutes postoperatively.)
  • Intraabdominal Pressure (IAP) at Defined Perioperative Time Points (mmHg)(From CO₂ insufflation to desufflation during the intraoperative period.)
  • Peripheral Oxygen Saturation (SpO₂) at Defined Perioperative Time Points (%)(From 10 minutes before anesthesia induction to 45 minutes postoperatively.)
  • End-Tidal Carbon Dioxide (ETCO₂) Levels at Defined Perioperative Time Points (mmHg)(From 10 minutes before anesthesia induction to 45 minutes postoperatively.)
  • Mean Arterial Pressure at Defined Perioperative Time Points (mmHg)(From 10 minutes before anesthesia induction to 45 minutes postoperatively.)
  • Arterial Partial Pressure of Oxygen (PaO₂) at Selected Perioperative Time Points (mmHg)(From 10 minutes before anesthesia induction to 45 minutes postoperatively.)
  • Arterial Partial Pressure of Carbon Dioxide (PaCO₂) at Selected Perioperative Time Points (mmHg)(From 10 minutes before anesthesia induction to 45 minutes postoperatively)
  • Arterial Blood pH at Selected Perioperative Time Points(From 10 minutes before anesthesia induction to 45 minutes postoperatively.)
  • Arterial Bicarbonate (HCO₃-) Level at Selected Perioperative Time Points (mEq/L)(From 10 minutes before anesthesia induction to 45 minutes postoperatively.)
  • Peak Airway Pressure During Surgery (cmH₂O)(From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position).)
  • Positive End-Expiratory Pressure (PEEP) During Surgery (cmH₂O)(From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position).)
  • Plateau Pressure During Surgery (cmH₂O)(From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position).)
  • Dynamic Pulmonary Compliance During Surgery (mL/cmH₂O)(From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position).)

研究者

发起方
Ataturk Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aysun Erşen Yüngül

Principal Investigator

Ataturk Training and Research Hospital

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