Skip to main content
OpenTrials
Completed

NCT Number: NCT07100314

Preoperative Toxicological Screening on Perioperative Anesthetic Management

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

In a cross-sectional study of elective surgery patients, Amin et al. found a strong positive correlation between toxicological screening drug detection and propofol induction dose, pain scores, and hospital stay. Similar findings were reported by Clavijo et al. in a prospective observational pilot study of patients undergoing spine surgery. They found inconsistencies between self-reporting and toxicological screening test results in 88% of patients, with significant correlations between polypharmacy and increased anesthesia requirements.

The MENA region provides unique challenges concerning substance use assessment owing to cultural, religious, and legal factors that may impact disclosure. Substance use is often stigmatized and criminalized in many MENA countries, potentially leading to underreporting during clinical evaluations. Epidemiological statistics show that drug usage patterns in the MENA region deviate from worldwide trends, with specific concerns about tramadol, cannabis, and prescription drugs. Tobacco usage remains prevalent throughout the area, with worries raised regarding the use of traditional medicines such as khat in certain regions. These drug use patterns have significant consequences for surgical patients because they may influence perioperative treatment, anesthetic requirements, and postoperative recovery. The stigmatization and underreporting of drug addiction in the MENA region highlights the importance of objective assessment methods, such as toxicological screening, to identify patients who may require modified perioperative management for patient safety and optimal care delivery.

The role of preoperative toxicological screening has been the subject of increasing research interest, particularly in procedures requiring careful perioperative management and in areas of uncertainty about patients' substance use disclosure. Despite the growing body of literature on this topic, there remains a gap in knowledge regarding the specific impact of preoperative substance use on outcomes following MBS, particularly in the MENA region, where substance use patterns and disclosure behaviors may differ from Western populations. This prospective observational study addressed this gap by evaluating the association between preoperative toxicological screening results and their impact on perioperative anesthetic management and short-term outcomes following MBS in Egypt.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Multi-Drug One Step Screen Test Panel (Urine)

Diagnostic Test

Tested positive

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Pain assessment

    Time frame: 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.

Secondary outcomes

  1. postoperative recovery parameter

    Time frame: during the first 24 hours after surgery.

    Recovery time, between the 2 groups of patients during the first 24 hours after surgery.

    General anesthesia recovery time is measured by assessing a patient's return to pre-anesthetic function, encompassing various domains including consciousness, cognitive function, and physical capabilities, with common tools like the QoR-15 scale being used to quantify quality of recovery. While patients typically begin to wake within minutes and may go home within hours, full recovery can take up to 24 hours or longer for some aspects, depending on the individual and the surgery.

  2. postoperative recovery parameter

    Time frame: during the first 24 hours after surgery

    Postoperative pain scores between the 2 groups of patients during the first 24 hours after surgery.

    Post-operative pain after general anesthesia is measured using the Visual Analog Scale (VAS), a 100mm line representing pain intensity. Acceptable pain levels post-surgery are generally considered to be mild to moderate, often defined as NRS scores of 4 or less, or VAS scores of 33 or less.

  3. postoperative recovery parameter

    Time frame: during the first 24 hours after surgery.

    Analgesic requirements between the 2 groups of patients during the first 24 hours after surgery.

    Measuring analgesia requirements during general anesthesia involves continuous physiological monitoring and the use of specialized indices to assess pain and nociception in real-time, allowing for titration of analgesic medications to effect and minimizing both under- and over-dosing.

    Standard Physiological Monitoring:

    Essential for overall patient safety and can provide indirect clues about pain or stress. This includes:

    Electrocardiography (ECG): Monitors heart rate and rhythm. Pulse Oximetry (SpO2): Measures oxygen saturation. Blood Pressure Monitoring (NIBP): Assesses cardiovascular stability. Capnography: Measures carbon dioxide exhaled, indicating ventilation adequacy. Temperature Measurement: Detects changes like hypothermia or fever.

  4. preoperative substance use affects short-term weight loss

    Time frame: 12 months postoperative

    To determine whether preoperative substance use affects short-term weight loss outcomes and associated medical problem resolution at one year following MBS. (in kilograms and BMI measured by weight in kilograms and height in meters)

Sponsors and collaborators

Lead sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.