{"title":"Clinical Efficacy Between Intravenous Paracetamol and Intravenous Fentanyl for Propofol Deep Sedation in Colonoscopy: A Randomized Controlled Trial.","authors":"Thanitthi Thiparporn, Wilaiporn Supan, Somchai Amornyotin","doi":"10.2147/DDDT.S479084","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Sedation practices for colonoscopy indeed vary widely around the globe. Due to a lack of data on intravenous paracetamol, we aimed to investigate the clinical efficacy of intravenous paracetamol compared to intravenous fentanyl under propofol deep sedation for colonoscopy.</p><p><strong>Methods: </strong>A total of 225 patients who underwent colonoscopy at Siriraj Hospital were randomly assigned to two groups. All patients underwent deep sedation with propofol and received intravenous (iv) paracetamol (group P, n = 113) or iv fentanyl (group F, n = 112). All patients received a premedication of 0.02-0.03 mg/kg of midazolam intravenously. Fifteen to thirty minutes before the procedure, patients in group P were administered 1000 mg of iv paracetamol, while those in group F received 0.001 mg/kg of iv fentanyl. All patients were oxygenated with 100% O<sub>2</sub> via a nasal cannula, and deep sedated with titrated intravenous propofol. The primary outcome measure was the success rate of colonoscopy. The colonoscope reaching the ileocecal valve was an important marker for a successful colonoscopy. Secondary outcome measures included endoscopist and patient satisfaction, patient tolerance, ease of the procedure, and sedation-related complications during and immediately after the procedure.</p><p><strong>Results: </strong>All colonoscopies were successfully completed. There were no significant differences in patient characteristics, duration of the procedure, endoscopist and patient satisfaction, patient tolerance, or ease of the procedure between the two groups. However, group F experienced significantly higher rates of upper airway obstruction and oxygen desaturation during the procedure compared to group P. No serious complications were observed in either group.</p><p><strong>Conclusion: </strong>Intravenous paracetamol with propofol deep sedation in adult patients is non-inferior to intravenous fentanyl for successful colonoscopy completion. Sedation-related complications were relatively lower in the propofol deep sedation with iv paracetamol group compared to the propofol deep sedation with iv fentanyl group.</p><p><strong>Registration: </strong>This trial was registered with the Thai Clinical Trial Registry (TCTR 20190321002).</p>","PeriodicalId":11290,"journal":{"name":"Drug Design, Development and Therapy","volume":"19 ","pages":"471-478"},"PeriodicalIF":4.7000,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11771515/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Design, Development and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/DDDT.S479084","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: Sedation practices for colonoscopy indeed vary widely around the globe. Due to a lack of data on intravenous paracetamol, we aimed to investigate the clinical efficacy of intravenous paracetamol compared to intravenous fentanyl under propofol deep sedation for colonoscopy.
Methods: A total of 225 patients who underwent colonoscopy at Siriraj Hospital were randomly assigned to two groups. All patients underwent deep sedation with propofol and received intravenous (iv) paracetamol (group P, n = 113) or iv fentanyl (group F, n = 112). All patients received a premedication of 0.02-0.03 mg/kg of midazolam intravenously. Fifteen to thirty minutes before the procedure, patients in group P were administered 1000 mg of iv paracetamol, while those in group F received 0.001 mg/kg of iv fentanyl. All patients were oxygenated with 100% O2 via a nasal cannula, and deep sedated with titrated intravenous propofol. The primary outcome measure was the success rate of colonoscopy. The colonoscope reaching the ileocecal valve was an important marker for a successful colonoscopy. Secondary outcome measures included endoscopist and patient satisfaction, patient tolerance, ease of the procedure, and sedation-related complications during and immediately after the procedure.
Results: All colonoscopies were successfully completed. There were no significant differences in patient characteristics, duration of the procedure, endoscopist and patient satisfaction, patient tolerance, or ease of the procedure between the two groups. However, group F experienced significantly higher rates of upper airway obstruction and oxygen desaturation during the procedure compared to group P. No serious complications were observed in either group.
Conclusion: Intravenous paracetamol with propofol deep sedation in adult patients is non-inferior to intravenous fentanyl for successful colonoscopy completion. Sedation-related complications were relatively lower in the propofol deep sedation with iv paracetamol group compared to the propofol deep sedation with iv fentanyl group.
Registration: This trial was registered with the Thai Clinical Trial Registry (TCTR 20190321002).
期刊介绍：
Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications.
The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas.
Specific topics covered by the journal include:
Drug target identification and validation
Phenotypic screening and target deconvolution
Biochemical analyses of drug targets and their pathways
New methods or relevant applications in molecular/drug design and computer-aided drug discovery*
Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes)
Structural or molecular biological studies elucidating molecular recognition processes
Fragment-based drug discovery
Pharmaceutical/red biotechnology
Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products**
Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development
Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing)
Preclinical development studies
Translational animal models
Mechanisms of action and signalling pathways
Toxicology
Gene therapy, cell therapy and immunotherapy
Personalized medicine and pharmacogenomics
Clinical drug evaluation
Patient safety and sustained use of medicines.
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