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临床试验/NCT06688643
NCT06688643已完成不适用

The Impact of Intrathecal Morphine Versus Continuous Epidural Analgesia on Return of Bowel Function in Patients Undergoing Laparoscopic Ileal Conduit : a Prospective, Randomized Controlled Trial

Xiaguang Duan1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
1
主要终点
bowel function recovery time

研究概览

简要总结

This study aims to compare the effects of intrathecal morphine (ITM) and continuous epidural analgesia (CEA) on bowel function recovery after Bricker surgery.This study was a prospective, randomized controlled trial that included 72 patients with bladder cancer undergoing elective Bricker surgery, who were randomly assigned to either the ITM group (n=36) or the CEA group (n=36). Postoperatively, patients in both groups received either ITM or CEA for pain management, and postoperative bowel function recovery time, pain scores, PONV, itching, and other indicators were recorded.

详细描述

Patients This study was approved by the Medical Ethics Committee of Baogang Hospital, Inner Mongolia (2021-MER-206) on October 11, 2021, and adhered to the Declaration of Helsinki and the Consolidated Standards of Reporting Trials (CONSORT) guidelines. All participants provided informed consent voluntarily. From January 25, 2022, to November 1, 2024, 72 patients (aged 50-90 years) with bladder cancer undergoing elective Bricker surgery were enrolled at Baogang Hospital, Inner Mongolia. All patients were classified as ASA I-III. Patients were excluded if they had allergies to any anesthetic agents used in this study or if they had adverse reactions to any of the analgesics included in the study. Patients who refused to sign the consent form or were uncooperative were deemed ineligible for clinical evaluation. Patients were excluded if they had uncontrolled hypertension, hypersensitivity to pain, a history of gastrointestinal disease, impaired cardiopulmonary function, cerebrovascular disease, sleep disorders, or psychiatric disorders.

Randomization and blinding Patients were randomly assigned to the ITM group (n=36) or EA group (n=36) using a random number table. Patients in the ITM group underwent intrathecal injection with 0.2 mg morphine after admission to the operating room. Patients in the EA group underwent epidural anesthesia after admission to the operating room. Following successful epidural puncture, 3 ml of 2% lidocaine was administered. Once the block level was confirmed, the epidural analgesia pump was activated, delivering 8 ml/h of 0.1% ropivacaine. General anesthesia with endotracheal intubation was administered to both groups after the aforementioned procedures. Patients and surgeons were blinded to group assignment, while the anesthesiologists and nurses administering anesthesia were aware of the group allocation.

General anesthesia and monitoring Upon arrival in the operating room, patients were monitored for pulse oximetry (SPO2), electrocardiogram (ECG), bispectral index (BIS), and non-invasive arterial blood pressure. Pain threshold (PTh, mA) and pain tolerance threshold (PTTh, mA) were measured and recorded. Patients received pre-operative administration of Penehyclidine Hydrochloride Injection (Lot H20051948, Chengdu List Pharmaceutical Co., Ltd., China) (0.01 mg kg-1 i.v.). Induction was achieved with propofol (1.5-2 mg kg-1 i.v.), rocuronium bromide (1-2 mg kg-1 i.v.), and fentanyl (1-2 μg kg-1 i.v.). Anesthesia was maintained with inhaled sevoflurane or desflurane, with the inhaled concentration adjusted according to BIS values. Remifentanil (0.05-0.2 μg kg-1 min-1 i.v.) was continuously infused to maintain blood pressure and heart rate within ±20% of baseline values. Mechanical ventilation was initiated in pressure-regulated volume control (PRVC) mode after induction. Ventilator settings (Aestiva; GE Healthcare, Waukesha, Wisconsin, USA) were as follows: tidal volume 6-8 ml kg-1, positive end-expiratory pressure (PEEP) 0 cmH2O, inspiratory-to-expiratory ratio 1:2, respiratory rate 16 beats per minute (BPM), and inspired oxygen concentration 41%. The patient was positioned in the Trendelenburg position, with the operating table tilted 20-25° head down. Carbon dioxide pneumoperitoneum was established at an intra-abdominal pressure of 10-15 mmHg.

Postoperative care Vital signs were monitored in the Post Anesthesia Care Unit (PACU), with supplemental oxygen provided via facemask. For hypotension, ephedrine (6-10 mg) was administered, and fluid administration was increased. Atropine (0.3-0.5 mg) was given for bradycardia. For pain, sufentanil (0.1-0.2 μg/kg) was administered.

Data collection Upon arrival in the operating room, HR (bpm), mean arterial pressure (MAP, mmHg) (calculated as MAP = diastolic pressure + 1/3 pulse pressure), BIS, remifentanil dosage (mg), ephedrine dosage (mg), duration of surgery (minutes), and duration of anesthesia (minutes) were recorded for all patients.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All participants provided informed consent voluntarily
  • ASA I-III

排除标准

  • allergies to any anesthetic agents used in this study
  • refused to sign the consent form
  • uncooperative were deemed ineligible for clinical evaluation
  • hypersensitivity to pain
  • a history of gastrointestinal disease
  • sleep disorders

结局指标

主要结局

bowel function recovery time

时间窗: 24 hours after surgery

12 hours indicates good bowel function, 24 hours indicates good bowel function.

次要结局

  • pain scores(24 hours after surgery)

研究者

发起方
Xiaguang Duan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xiaguang Duan

Deputy Chief of Anesthesiology

Inner Mongolia Baogang Hospital

研究点 (1)

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