Low-Dose Esketamine as an Adjuvant to Propofol Sedation for Same-Visit Bidirectional Endoscopy: Protocol for a Multicenter Randomized Controlled Trial
Nan Song,1,2,* Xi-Sheng Shan,1,2,* Yi Yang,3 Zhong Zheng,4 Wen-Cheng Shi,4 Xiao-Yan Yang,3 Yang Li,3 Ai-Ping Tan,3 Hong Liu,5 Ke Peng,1,2 Fu-Hai Ji1,2 1Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, People’s Republic of China; 2Institu...
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Dove Medical Press
2022-05-01
|
| Series: | International Journal of General Medicine |
| Subjects: | |
| Online Access: | https://www.dovepress.com/low-dose-esketamine-as-an-adjuvant-to-propofol-sedation-for-same-visit-peer-reviewed-fulltext-article-IJGM |
| _version_ | 1818201839541157888 |
|---|---|
| author | Song N Shan XS Yang Y Zheng Z Shi WC Yang XY Li Y Tan AP Liu H Peng K Ji FH |
| author_facet | Song N Shan XS Yang Y Zheng Z Shi WC Yang XY Li Y Tan AP Liu H Peng K Ji FH |
| author_sort | Song N |
| collection | DOAJ |
| description | Nan Song,1,2,* Xi-Sheng Shan,1,2,* Yi Yang,3 Zhong Zheng,4 Wen-Cheng Shi,4 Xiao-Yan Yang,3 Yang Li,3 Ai-Ping Tan,3 Hong Liu,5 Ke Peng,1,2 Fu-Hai Ji1,2 1Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, People’s Republic of China; 2Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, People’s Republic of China; 3Department of Anesthesiology, the People’s Hospital of SND, Suzhou, Jiangsu, People’s Republic of China; 4Department of Anesthesiology, Taicang First People’s Hospital, Taicang, Jiangsu, People’s Republic of China; 5Department of Anesthesiology and Pain Medicine, University of California Davis Health System, Sacramento, CA, USA*These authors contributed equally to this workCorrespondence: Fu-Hai Ji, Chair and Professor, Department of Anesthesiology, First Affiliated Hospital of Soochow University, 188 Shizi Street, Suzhou, Jiangsu, 215006, People’s Republic of China, Tel +86-512-67780056, Email jifuhaisuda@163.com Ke Peng, Acting Vice Chair for Research and Associate Professor, Department of Anesthesiology, First Affiliated Hospital of Soochow University, 188 Shizi Street, Suzhou, Jiangsu, 215006, People’s Republic of China, Tel +86-512-67780055, Email pengke0422@163.comBackground: Same-visit bidirectional endoscopy (esophagogastroduodenoscopy and colonoscopy) is widely performed under sedation. At present, the optimal sedation regimen remains unclear. This study aims to test the hypothesis that a low-dose esketamine added to propofol sedation reduces hemodynamic and respiratory adverse events in these procedures.Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, 660 adult patients scheduled for same-visit bidirectional endoscopy under sedation from 3 teaching hospitals in China will be recruited. Patients will be randomly allocated, in a 1:1 ratio, to an esketamine group or a normal saline group (n = 330 in each group), stratified by study center. All patients will receive intravenous propofol 0.5 mg/kg and sufentanil 0.1 μg/mL for induction of sedation, followed by intravenous esketamine 0.15 mg/kg or the same volume of normal saline. Propofol will be titrated to the target sedation levels during the procedures. The primary endpoint is a composite of desaturation (peripheral oxygen saturation < 90%) and hypotension (systolic blood pressure < 80 mmHg or decrease > 30% of baseline). Secondary endpoints include desaturation, hypotension, total dose of propofol, pain scores and fatigue scores on the 0– 10 numerical rating scale, dizziness or headache, hallucination or nightmare, nausea or vomiting, endoscopist satisfaction, and patient satisfaction. All analyses will be intention-to-treat.Discussion: We expect that a low-dose esketamine adjunct to propofol-based sedation will improve cardiorespiratory stability in patients undergoing same-visit bidirectional endoscopy, providing reference for clinical sedation practice during these procedures.Trial Registration: Chinese Clinical Trial Registry (Identifier: ChiCTR-ChiCTR2200055938).Keywords: esketamine, propofol, sedation, bidirectional endoscopy, desaturation, hypotension |
| first_indexed | 2024-12-12T02:59:56Z |
| format | Article |
| id | doaj.art-5568d5d2eb484cf9a6c1042215a2d3d2 |
| institution | Directory Open Access Journal |
| issn | 1178-7074 |
| language | English |
| last_indexed | 2024-12-12T02:59:56Z |
| publishDate | 2022-05-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | International Journal of General Medicine |
| spelling | doaj.art-5568d5d2eb484cf9a6c1042215a2d3d22022-12-22T00:40:39ZengDove Medical PressInternational Journal of General Medicine1178-70742022-05-01Volume 154733474075113Low-Dose Esketamine as an Adjuvant to Propofol Sedation for Same-Visit Bidirectional Endoscopy: Protocol for a Multicenter Randomized Controlled TrialSong NShan XSYang YZheng ZShi WCYang XYLi YTan APLiu HPeng KJi FHNan Song,1,2,* Xi-Sheng Shan,1,2,* Yi Yang,3 Zhong Zheng,4 Wen-Cheng Shi,4 Xiao-Yan Yang,3 Yang Li,3 Ai-Ping Tan,3 Hong Liu,5 Ke Peng,1,2 Fu-Hai Ji1,2 1Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, People’s Republic of China; 2Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, People’s Republic of China; 3Department of Anesthesiology, the People’s Hospital of SND, Suzhou, Jiangsu, People’s Republic of China; 4Department of Anesthesiology, Taicang First People’s Hospital, Taicang, Jiangsu, People’s Republic of China; 5Department of Anesthesiology and Pain Medicine, University of California Davis Health System, Sacramento, CA, USA*These authors contributed equally to this workCorrespondence: Fu-Hai Ji, Chair and Professor, Department of Anesthesiology, First Affiliated Hospital of Soochow University, 188 Shizi Street, Suzhou, Jiangsu, 215006, People’s Republic of China, Tel +86-512-67780056, Email jifuhaisuda@163.com Ke Peng, Acting Vice Chair for Research and Associate Professor, Department of Anesthesiology, First Affiliated Hospital of Soochow University, 188 Shizi Street, Suzhou, Jiangsu, 215006, People’s Republic of China, Tel +86-512-67780055, Email pengke0422@163.comBackground: Same-visit bidirectional endoscopy (esophagogastroduodenoscopy and colonoscopy) is widely performed under sedation. At present, the optimal sedation regimen remains unclear. This study aims to test the hypothesis that a low-dose esketamine added to propofol sedation reduces hemodynamic and respiratory adverse events in these procedures.Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, 660 adult patients scheduled for same-visit bidirectional endoscopy under sedation from 3 teaching hospitals in China will be recruited. Patients will be randomly allocated, in a 1:1 ratio, to an esketamine group or a normal saline group (n = 330 in each group), stratified by study center. All patients will receive intravenous propofol 0.5 mg/kg and sufentanil 0.1 μg/mL for induction of sedation, followed by intravenous esketamine 0.15 mg/kg or the same volume of normal saline. Propofol will be titrated to the target sedation levels during the procedures. The primary endpoint is a composite of desaturation (peripheral oxygen saturation < 90%) and hypotension (systolic blood pressure < 80 mmHg or decrease > 30% of baseline). Secondary endpoints include desaturation, hypotension, total dose of propofol, pain scores and fatigue scores on the 0– 10 numerical rating scale, dizziness or headache, hallucination or nightmare, nausea or vomiting, endoscopist satisfaction, and patient satisfaction. All analyses will be intention-to-treat.Discussion: We expect that a low-dose esketamine adjunct to propofol-based sedation will improve cardiorespiratory stability in patients undergoing same-visit bidirectional endoscopy, providing reference for clinical sedation practice during these procedures.Trial Registration: Chinese Clinical Trial Registry (Identifier: ChiCTR-ChiCTR2200055938).Keywords: esketamine, propofol, sedation, bidirectional endoscopy, desaturation, hypotensionhttps://www.dovepress.com/low-dose-esketamine-as-an-adjuvant-to-propofol-sedation-for-same-visit-peer-reviewed-fulltext-article-IJGMesketaminepropofolsedationbidirectional endoscopydesaturationhypotension |
| spellingShingle | Song N Shan XS Yang Y Zheng Z Shi WC Yang XY Li Y Tan AP Liu H Peng K Ji FH Low-Dose Esketamine as an Adjuvant to Propofol Sedation for Same-Visit Bidirectional Endoscopy: Protocol for a Multicenter Randomized Controlled Trial International Journal of General Medicine esketamine propofol sedation bidirectional endoscopy desaturation hypotension |
| title | Low-Dose Esketamine as an Adjuvant to Propofol Sedation for Same-Visit Bidirectional Endoscopy: Protocol for a Multicenter Randomized Controlled Trial |
| title_full | Low-Dose Esketamine as an Adjuvant to Propofol Sedation for Same-Visit Bidirectional Endoscopy: Protocol for a Multicenter Randomized Controlled Trial |
| title_fullStr | Low-Dose Esketamine as an Adjuvant to Propofol Sedation for Same-Visit Bidirectional Endoscopy: Protocol for a Multicenter Randomized Controlled Trial |
| title_full_unstemmed | Low-Dose Esketamine as an Adjuvant to Propofol Sedation for Same-Visit Bidirectional Endoscopy: Protocol for a Multicenter Randomized Controlled Trial |
| title_short | Low-Dose Esketamine as an Adjuvant to Propofol Sedation for Same-Visit Bidirectional Endoscopy: Protocol for a Multicenter Randomized Controlled Trial |
| title_sort | low dose esketamine as an adjuvant to propofol sedation for same visit bidirectional endoscopy protocol for a multicenter randomized controlled trial |
| topic | esketamine propofol sedation bidirectional endoscopy desaturation hypotension |
| url | https://www.dovepress.com/low-dose-esketamine-as-an-adjuvant-to-propofol-sedation-for-same-visit-peer-reviewed-fulltext-article-IJGM |
| work_keys_str_mv | AT songn lowdoseesketamineasanadjuvanttopropofolsedationforsamevisitbidirectionalendoscopyprotocolforamulticenterrandomizedcontrolledtrial AT shanxs lowdoseesketamineasanadjuvanttopropofolsedationforsamevisitbidirectionalendoscopyprotocolforamulticenterrandomizedcontrolledtrial AT yangy lowdoseesketamineasanadjuvanttopropofolsedationforsamevisitbidirectionalendoscopyprotocolforamulticenterrandomizedcontrolledtrial AT zhengz lowdoseesketamineasanadjuvanttopropofolsedationforsamevisitbidirectionalendoscopyprotocolforamulticenterrandomizedcontrolledtrial AT shiwc lowdoseesketamineasanadjuvanttopropofolsedationforsamevisitbidirectionalendoscopyprotocolforamulticenterrandomizedcontrolledtrial AT yangxy lowdoseesketamineasanadjuvanttopropofolsedationforsamevisitbidirectionalendoscopyprotocolforamulticenterrandomizedcontrolledtrial AT liy lowdoseesketamineasanadjuvanttopropofolsedationforsamevisitbidirectionalendoscopyprotocolforamulticenterrandomizedcontrolledtrial AT tanap lowdoseesketamineasanadjuvanttopropofolsedationforsamevisitbidirectionalendoscopyprotocolforamulticenterrandomizedcontrolledtrial AT liuh lowdoseesketamineasanadjuvanttopropofolsedationforsamevisitbidirectionalendoscopyprotocolforamulticenterrandomizedcontrolledtrial AT pengk lowdoseesketamineasanadjuvanttopropofolsedationforsamevisitbidirectionalendoscopyprotocolforamulticenterrandomizedcontrolledtrial AT jifh lowdoseesketamineasanadjuvanttopropofolsedationforsamevisitbidirectionalendoscopyprotocolforamulticenterrandomizedcontrolledtrial |