ToxicologyNCT07100314
Preoperative Toxicological Screening on Perioperative Anesthetic Management
An observational study of Toxicology and Bariatric Surgery Analgesia, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Toxicology, Bariatric Surgery Analgesia, Bariatric Surgery
- What is being tested?
- Multi-Drug One Step Screen Test Panel (Urine)
- How many people
- 1,260 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 1,260 patients were enrolled in the study and underwent preoperative toxicological screening tests (TST). The study population had a mean age of 38.4 ± 9.7 years, with a predominance of female patients (72.3%). The mean preoperative BMI was 44.2 ± 6.8 kg/m². Laparoscopic sleeve gastrectomy (LSG) was the most common procedure (68.3%), followed by one-anastomosis gastric bypass (OAGB, 21.4%) and Roux-en-Y gastric bypass (RYGB, 10.3%). Of the 1,260 patients, 190 (15.1%) tested positive on preoperative TST for at least one substance. The most detected substances were tramadol (52.6% of positive tests), cannabis (28.4%), benzodiazepines (15.8%), opiates (10.5%), amphetamines (7.9%), barbiturates (5.3%), and cocaine (2.6%). Multiple substances were detected in 18.4% of TST-positive patients. Figure 1 illustrates the distribution of substances detected in the TST-positive group.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
The surgical department of Medical Research Institute Hospital, Alexandria University
Alexandria, 21531
About this study
Official title: Impact of Preoperative Toxicological Screening on Perioperative Anesthetic Management and Short-Term Outcomes Following Metabolic Bariatric Surgery: An Observational Study.
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
- 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.
- 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.
- 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.
Read the detailed description
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.
- Being tested
- Multi-Drug One Step Screen Test Panel (Urine)
- Keywords
- Metabolic bariatric surgery, toxicological screening, substance use, short-term outcomes, pain management, anesthesia requirements, postoperative complications, weight loss
- Medical subject headings
- Substance-Related Disorders, Agnosia, Postoperative Complications, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Drug One Step Screen Test Panel (Urine)Diagnostic test
Tested positive
Multi-Drug One Step Screen Test Panel (Urine)Diagnostic test
tested negative
| Study group | Role | What they receive |
|---|---|---|
| TST-positive | The toxicological panel tested for seven major categories of substances:
1. COC (Cocaine): Detection of cocaine metabolites indicating recent cocaine use
2. AMP (Amphetamines): Screening for amphetamine and methamphetamine compounds
3. THC (Tetrahydrocannabinol): Detection of cannabis metabolites
4. MOP (Morphine/Opiates): Screening for morphine, codeine, and related opiate compounds
5. TRA (Tramadol): Specific detection of tramadol, a commonly prescribed analgesic in the region
6. BAR (Barbiturates): Detection of barbiturate compounds
7. BZO (Benzodiazepines): Screening for benzodiazepine medications Receives: Diagnostic Test: Multi-Drug One Step Screen Test Panel (Urine) | |
| TST-negative | patients that tested negative in the dipstick test. Receives: Diagnostic Test: Multi-Drug One Step Screen Test Panel (Urine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
history of specific substance use and /or detected by toxicological screening
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.
Measured: within 30 days post operative
Anesthesia-related outcomes included dosages of induction agents (specifically propofol) and perioperative opioid consumption (intraoperative fentanyl dose and postoperative morphine consumption).
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.
Measured: within 30 days post operative
Pain assessment
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.
Measured: within 30 days post operative
Secondary outcomes (4)
postoperative recovery parameter
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.
Measured: during the first 24 hours after surgery.
postoperative recovery parameter
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.
Measured: during the first 24 hours after surgery
postoperative recovery parameter
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.
Measured: during the first 24 hours after surgery.
preoperative substance use affects short-term weight loss
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)
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Dec 2023
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ToxicologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,260 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Hany Ashour, General Committee of Teaching Hospitals and Institutes, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100314
- Sponsor's protocol ID
- Preoperative Toxicology
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The analysis will be performed on a blinded dataset after completing the medical/scientific review. All protocol violations will be identified and resolved, and the dataset will be declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com), handled according to Good Clinical Practice guidelines, Data Protection Directive certificate, and complied with Title 21 CFR Part 11. Furthermore, the data centers where all the research data will be stored are certified according to ISO27001, ISO9001, and Dutch NEN7510. Can be asked by the contact person
Publications
Hany M, Hozien AI, Mohamed Hussein HAS, El-Sayes I, Hashem EY, Elmongui E, El Shamarka A, El Ansari W. Impact of Preoperative Toxicological Screening on Perioperative Anesthetic Management and Short-Term Outcomes Following Metabolic and Bariatric Surgery: A Prospective Observational Study. Obes Surg. 2026 May;36(5):2132-2149. doi: 10.1007/s11695-026-08534-3. Epub 2026 Mar 31.
PubMed 41915289
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Toxicological Screening on Perioperative Anesthetic Management and Short-Term Outcomes Following Metabolic Bariatric Surgery: An Observational Study.
- ClinicalTrials.gov ID
- NCT07100314
- Acronym / sponsor ID
- Preoperative Toxicology
- Keywords
- Metabolic bariatric surgery, toxicological screening, substance use, short-term outcomes, pain management, anesthesia requirements, postoperative complications, weight loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,260 participants (actual)
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, EgyptOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TST-positive | – | Diagnostic Test: Multi-Drug One Step Screen Test Panel (Urine)The toxicological panel tested for seven major categories of substances: 1. COC (Cocaine): Detection of cocaine metabolites indicating recent cocaine use 2. AMP (Amphetamines): Screening for amphetamine and methamphetamine compounds 3. THC (Tetrahydrocannabinol): Detection of cannabis metabolites 4. MOP (Morphine/Opiates): Screening for morphine, codeine, and related opiate compounds 5. TRA (Tramadol): Specific detection of tramadol, a commonly prescribed analgesic in the region 6. BAR (Barbiturates): Detection of barbiturate compounds 7. BZO (Benzodiazepines): Screening for benzodiazepine medications |
| TST-negative | – | Diagnostic Test: Multi-Drug One Step Screen Test Panel (Urine)patients that tested negative in the dipstick test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 1,260 patients were enrolled in the study and underwent preoperative toxicological screening tests (TST). The study population had a mean age of 38.4 ± 9.7 years, with a predominance of female patients (72.3%). The mean preoperative BMI was 44.2 ± 6.8 kg/m². Laparoscopic sleeve gastrectomy (LSG) was the most common procedure (68.3%), followed by one-anastomosis gastric bypass (OAGB, 21.4%) and Roux-en-Y gastric bypass (RYGB, 10.3%). Of the 1,260 patients, 190 (15.1%) tested positive on preoperative TST for at least one substance. The most detected substances were tramadol (52.6% of positive tests), cannabis (28.4%), benzodiazepines (15.8%), opiates (10.5%), amphetamines (7.9%), barbiturates (5.3%), and cocaine (2.6%). Multiple substances were detected in 18.4% of TST-positive patients. Figure 1 illustrates the distribution of substances detected in the TST-positive group.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Drug One Step Screen Test Panel (Urine)Tested positive | Diagnostic test | TST-positive |
| Multi-Drug One Step Screen Test Panel (Urine)tested negative | Diagnostic test | TST-negative |
Primary outcome
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.
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.
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.
4 secondary outcomes
postoperative recovery parameter
Time frame: during the first 24 hours after surgery.
postoperative recovery parameter
Time frame: during the first 24 hours after surgery
postoperative recovery parameter
Time frame: during the first 24 hours after surgery.
preoperative substance use affects short-term weight loss
Time frame: 12 months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Derived from this study: PubMed 41915289Hany M, Hozien AI, Mohamed Hussein HAS, El-Sayes I, Hashem EY, Elmongui E, El Shamarka A, El Ansari W. Impact of Preoperative Toxicological Screening on Perioperative Anesthetic Management and Short-Term Outcomes Following Metabolic and Bariatric Surgery: A Prospective Observational Study. Obes Surg. 2026 May;36(5):2132-2149. doi: 10.1007/s11695-026-08534-3. Epub 2026 Mar 31.
- Individual participant dataSharing planned: Yes. The analysis will be performed on a blinded dataset after completing the medical/scientific review. All protocol violations will be identified and resolved, and the dataset will be declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com), handled according to Good Clinical Practice guidelines, Data Protection Directive certificate, and complied with Title 21 CFR Part 11. Furthermore, the data centers where all the research data will be stored are certified according to ISO27001, ISO9001, and Dutch NEN7510. Can be asked by the contact person
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Toxicology and Bariatric Surgery Analgesia, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
history of specific substance use and /or detected by toxicological screening (time frame: within 30 days post operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07100314, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.