Esketamine as an Adjuvant to Ciprofol or Propofol Sedation for Same-Day Bidirectional Endoscopy: Protocol for a Randomized, Double-Blind, Controlled Trial With Factorial Design
Background: Same-day esophagogastroduodenoscopy and colonoscopy procedures under sedation have been increasingly performed. This study aims to assess the effects of esketamine combined with ciprofol (a novel anesthetic/sedative agent) or propofol on respiratory and hemodynamic adverse events in pati...
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Frontiers Media S.A.
2022-03-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2022.821691/full |
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| author | Yu-qin Long Yu-qin Long Chang-dong Feng Chang-dong Feng Yun-ying Ding Yun-ying Ding Xiao-mei Feng Hong Liu Fu-hai Ji Fu-hai Ji Ke Peng Ke Peng |
| author_facet | Yu-qin Long Yu-qin Long Chang-dong Feng Chang-dong Feng Yun-ying Ding Yun-ying Ding Xiao-mei Feng Hong Liu Fu-hai Ji Fu-hai Ji Ke Peng Ke Peng |
| author_sort | Yu-qin Long |
| collection | DOAJ |
| description | Background: Same-day esophagogastroduodenoscopy and colonoscopy procedures under sedation have been increasingly performed. This study aims to assess the effects of esketamine combined with ciprofol (a novel anesthetic/sedative agent) or propofol on respiratory and hemodynamic adverse events in patients undergoing same-day bidirectional endoscopy.Methods: This is a prospective, randomized, double-blind, placebo-controlled, 2 × 2 factorial trial. A total of 180 adult patients scheduled for same-day bidirectional endoscopy under sedation will be randomized, in a 1:1:1:1 ratio, to receive 1 of 4 sedation regimens: 1) ciprofol and esketamine, 2) propofol and esketamine, 3) ciprofol and normal saline placebo, or 4) propofol and normal saline placebo. The primary outcome is a composite of desaturation [peripheral oxygen saturation (SpO2) < 95%] and hypotension [mean blood pressure (MBP) < 65 mmHg or decrease in MBP ≥20% of baseline] during the sedation and in the recovery room. Secondary outcomes include episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in MBP ≥30% of baseline), bradycardia, postoperative nausea and vomiting, dizziness or headache, hallucination or nightmare, injection pain, pain scores and fatigue scores, endoscopist satisfaction, and patient satisfaction. Data will be analyzed on the modified intention-to-treat basis.Discussion: We hypothesize that esketamine as an adjuvant to ciprofol or propofol sedation would improve cardiorespiratory stability. In addition, the potential interactions between interventions will be explored using the factorial design. The results of this trial will provide evidence for daily practice of sedation regimens for same-day bidirectional endoscopy.Clinical Trial Registration: Chinese Clinical Trials Registry, Identifier ChiCTR2100052523. |
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| format | Article |
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| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-12-14T05:34:29Z |
| publishDate | 2022-03-01 |
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| series | Frontiers in Pharmacology |
| spelling | doaj.art-c8e2f5d044914a759b139c30f0e93f8f2022-12-21T23:15:14ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-03-011310.3389/fphar.2022.821691821691Esketamine as an Adjuvant to Ciprofol or Propofol Sedation for Same-Day Bidirectional Endoscopy: Protocol for a Randomized, Double-Blind, Controlled Trial With Factorial DesignYu-qin Long0Yu-qin Long1Chang-dong Feng2Chang-dong Feng3Yun-ying Ding4Yun-ying Ding5Xiao-mei Feng6Hong Liu7Fu-hai Ji8Fu-hai Ji9Ke Peng10Ke Peng11Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, ChinaInstitute of Anesthesiology, Soochow University, Suzhou, ChinaDepartment of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, ChinaInstitute of Anesthesiology, Soochow University, Suzhou, ChinaDepartment of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, ChinaInstitute of Anesthesiology, Soochow University, Suzhou, ChinaDepartment of Anesthesiology, University of Utah, Salt Lake City, UT, United StatesDepartment of Anesthesiology and Pain Medicine, University of California Davis Health System, Sacramento, CA, United StatesDepartment of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, ChinaInstitute of Anesthesiology, Soochow University, Suzhou, ChinaDepartment of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, ChinaInstitute of Anesthesiology, Soochow University, Suzhou, ChinaBackground: Same-day esophagogastroduodenoscopy and colonoscopy procedures under sedation have been increasingly performed. This study aims to assess the effects of esketamine combined with ciprofol (a novel anesthetic/sedative agent) or propofol on respiratory and hemodynamic adverse events in patients undergoing same-day bidirectional endoscopy.Methods: This is a prospective, randomized, double-blind, placebo-controlled, 2 × 2 factorial trial. A total of 180 adult patients scheduled for same-day bidirectional endoscopy under sedation will be randomized, in a 1:1:1:1 ratio, to receive 1 of 4 sedation regimens: 1) ciprofol and esketamine, 2) propofol and esketamine, 3) ciprofol and normal saline placebo, or 4) propofol and normal saline placebo. The primary outcome is a composite of desaturation [peripheral oxygen saturation (SpO2) < 95%] and hypotension [mean blood pressure (MBP) < 65 mmHg or decrease in MBP ≥20% of baseline] during the sedation and in the recovery room. Secondary outcomes include episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in MBP ≥30% of baseline), bradycardia, postoperative nausea and vomiting, dizziness or headache, hallucination or nightmare, injection pain, pain scores and fatigue scores, endoscopist satisfaction, and patient satisfaction. Data will be analyzed on the modified intention-to-treat basis.Discussion: We hypothesize that esketamine as an adjuvant to ciprofol or propofol sedation would improve cardiorespiratory stability. In addition, the potential interactions between interventions will be explored using the factorial design. The results of this trial will provide evidence for daily practice of sedation regimens for same-day bidirectional endoscopy.Clinical Trial Registration: Chinese Clinical Trials Registry, Identifier ChiCTR2100052523.https://www.frontiersin.org/articles/10.3389/fphar.2022.821691/fullciprofolpropofolesketaminesedationbidirectional endoscopy |
| spellingShingle | Yu-qin Long Yu-qin Long Chang-dong Feng Chang-dong Feng Yun-ying Ding Yun-ying Ding Xiao-mei Feng Hong Liu Fu-hai Ji Fu-hai Ji Ke Peng Ke Peng Esketamine as an Adjuvant to Ciprofol or Propofol Sedation for Same-Day Bidirectional Endoscopy: Protocol for a Randomized, Double-Blind, Controlled Trial With Factorial Design Frontiers in Pharmacology ciprofol propofol esketamine sedation bidirectional endoscopy |
| title | Esketamine as an Adjuvant to Ciprofol or Propofol Sedation for Same-Day Bidirectional Endoscopy: Protocol for a Randomized, Double-Blind, Controlled Trial With Factorial Design |
| title_full | Esketamine as an Adjuvant to Ciprofol or Propofol Sedation for Same-Day Bidirectional Endoscopy: Protocol for a Randomized, Double-Blind, Controlled Trial With Factorial Design |
| title_fullStr | Esketamine as an Adjuvant to Ciprofol or Propofol Sedation for Same-Day Bidirectional Endoscopy: Protocol for a Randomized, Double-Blind, Controlled Trial With Factorial Design |
| title_full_unstemmed | Esketamine as an Adjuvant to Ciprofol or Propofol Sedation for Same-Day Bidirectional Endoscopy: Protocol for a Randomized, Double-Blind, Controlled Trial With Factorial Design |
| title_short | Esketamine as an Adjuvant to Ciprofol or Propofol Sedation for Same-Day Bidirectional Endoscopy: Protocol for a Randomized, Double-Blind, Controlled Trial With Factorial Design |
| title_sort | esketamine as an adjuvant to ciprofol or propofol sedation for same day bidirectional endoscopy protocol for a randomized double blind controlled trial with factorial design |
| topic | ciprofol propofol esketamine sedation bidirectional endoscopy |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2022.821691/full |
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