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临床试验/NCT07100314
NCT07100314已完成不适用

Impact of Preoperative Toxicological Screening on Perioperative Anesthetic Management and Short-Term Outcomes Following Metabolic Bariatric Surgery: An Observational Study.

General Committee of Teaching Hospitals and Institutes, Egypt1 个研究点 分布在 1 个国家目标入组 1,260 人开始时间: 2023年12月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,260
试验地点
1
主要终点
history of specific substance use and /or detected by toxicological screening

研究概览

简要总结

Background: Preoperative substance use is a growing concern in patients undergoing metabolic bariatric surgery (MBS), but its impact on short-term outcomes remains debated. This study evaluated the association between preoperative toxicological screening test (TST) results and perioperative outcomes, including anesthesia requirements, postoperative recovery, complications, and one-year weight loss in patients undergoing MBS.

Key Points

  1. Preoperative toxicological screening identifies a significant proportion (15.1%) of patients undergoing metabolic bariatric surgery with recent substance use that may not be disclosed through self-reporting.
  2. Patients with positive toxicological screening tests require significantly higher anesthesia doses, experience more severe postoperative pain, and have higher rates of complications and readmissions within 30 days.
  3. While short-term weight loss outcomes at one year show modest differences between toxicological screening test-positive and negative patients, the perioperative risk profile suggests the need for tailored management strategies for patients with recent substance use.

详细描述

The Middle East and North Africa (MENA) region has experienced a particularly rapid increase in obesity prevalence over recent decades, with some countries reporting rates exceeding 35% among adults. This trend is attributed to rapid urbanization, economic development, adoption of Western dietary patterns, and reduced physical activity. The high prevalence of obesity in the MENA region has created an urgent need for effective treatment strategies, including metabolic bariatric surgery (MBS).

MBS has established itself as the most effective long-term treatment for severe obesity, offering substantial and sustained weight loss along with resolution of obesity-related medical problems. The field has evolved significantly over the past decades, with procedures such as laparoscopic sleeve gastrectomy (LSG), Roux-en-Y gastric bypass (RYGB), and one-anastomosis gastric bypass (OAGB) becoming standard treatments for patients with severe obesity. These procedures not only achieve significant weight reduction but also provide remarkable improvements in type 2 diabetes, hypertension, dyslipidemia, and other obesity-related conditions.

The success of MBS depends on careful patient selection, thorough preoperative evaluation, and appropriate perioperative management. Substance use has become an important consideration among the factors influencing surgical outcomes. Substance use can affect wound healing and adherence to postoperative care protocols, potentially compromising surgical outcomes.

Managing anesthesia for obesity surgery in patients with substance abuse disorders presents a complex array of challenges. Obesity complicates airway management, alters pharmacokinetics and dynamics, demanding careful drug dosing and vigilant cardiopulmonary monitoring. Furthermore, chronic opioid users exhibit exaggerated pain, requiring dose modifications perioperatively but escalating risks of respiratory depression and postoperative hyperalgesia or withdrawal. Cocaine and amphetamine abuse increase the risks of arrhythmias, hypertension, myocardial ischemia, and unpredictable interactions with anesthetic agents. There is a necessity for multidisciplinary comprehensive perioperative optimization, including addiction consultation, careful substance withdrawal management, individualized anesthetic and surgical plans, multimodal analgesia, and extended postoperative monitoring for the possibility of respiratory complications and acute withdrawal symptoms.

A recent study by Chao et al. examined the association between toxicology positivity and outcomes in MBS patients in a retrospective review of 1,057 patients who underwent laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass. They found that 12.7% of patients had positive toxicology testing, with benzodiazepines (5.6%), opiates (3.5%), and cotinine (2.0%) being the most common substances detected. Their study did not find significant associations between toxicology positivity and preoperative length of time, 30-day complications, readmissions, or one-year weight loss.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • adult patients (≥18 years) with obesity who were scheduled to undergo primary MBS, including laparoscopic sleeve gastrectomy (LSG), Roux-en-Y gastric bypass (RYGB), or one-anastomosis gastric bypass (OAGB)
  • Patient selection followed the 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) guidelines for MBS

排除标准

  • previous bariatric or major abdominal surgery
  • emergency procedures
  • chronic pain syndromes
  • severe psychiatric illness
  • patient refusal that would impair informed consent or compliance with study protocols
  • inability to complete follow-up assessments

结局指标

主要结局

history of specific substance use and /or detected by toxicological screening

时间窗: within 30 days post operative

To determine the prevalence and patterns of substance use detected by preoperative toxicological screening tests (TST) in patients undergoing metabolic bariatric surgery (MBS) in the MENA region. Additional information regarding prescription status (prescribed versus self-prescribed) was obtained through structured patient interviews conducted by trained clinical staff for differentiation between legitimate medical use and recreational or non-prescribed substance use.

Anesthesia-related outcomes included dosages of induction agents (specifically propofol) and perioperative opioid consumption (intraoperative fentanyl dose and postoperative morphine consumption).

时间窗: within 30 days post operative

Recovery parameters were assessed, including recovery time (measured in minutes from extubation till meeting discharge criteria from the operative theatre (OR) to the post-anesthesia care unit (PACU)) and recovery status evaluated through Richmond Agitation-Sedation Scale (RASS). The RASS is a 10-point scale that ranges from -5 to +4, designed to evaluate a patient's level of alertness and agitation during recovery. Levels -1 to -5 denote 5 levels of sedation; levels +1 to +4 describe increasing levels of agitation. RASS level 0 is "alert and calm.

Pain assessment

时间窗: within 30 days post operative

was conducted using the Visual Analog Scale (VAS), measured multiple times during the first postoperative day: baseline, 1 hour, 6 hours, 12 hours, and 24 hours post-surgery. The VAS is a validated tool for pain assessment that consists of a 10-cm horizontal line with endpoints representing "no pain" (0) and "worst possible pain" (10). Patients were given 3 mg morphine if VAS scores reached ≥ 4. The time to first opioid request was also recorded as an indicator of pain onset and severity.

次要结局

  • postoperative recovery parameter(during the first 24 hours after surgery.)
  • preoperative substance use affects short-term weight loss(12 months postoperative)

研究者

发起方
General Committee of Teaching Hospitals and Institutes, Egypt
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mohamed Hany Ashour

Professor of General surgery

General Committee of Teaching Hospitals and Institutes, Egypt

研究点 (1)

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