A Phase 4 interventional study of Opioid-sparing based anesthesia and Sevoflurane-based anesthesia in Anesthesia, Hypoventilation and Opioid Use, sponsored by Tanta University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Tanta University · Phase 4, Interventional, and Treatment
Determine the incidence of early post-operative hypoventilation in post-anesthesia care unit (PACU) in patients undergoing laparoscopic bariatric surgery under opioid-sparing compared with sevoflurane-based anesthesia.
The incidence of early postoperative hypoxemia in the literature is diverse, this may be due to multivariable, including patient-related factors, anesthesia-related factors, and surgery-related factors. Because of the controverse regarding the incidence of postoperative hypoxemia and the evidence of anesthetic technique of choice, interest in prevention and early management of early postoperative hypoxemia after laparoscopic bariatric surgery is continued.
96 studies on the registry are indexed under Hypoventilation; 21 are open to participants now.
This study's planned enrollment of 72 is above the median of 52 across 63 interventional studies indexed under Hypoventilation.
Browse Hypoventilation studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Intraoperative opioid-sparing maintenance comprised dexmedetomidine bolus dose of 1 mcg/kg followed by 0.3 mcg/kg/h, propofol 4-8 mg/kg/h and ketamine 25 mg/h for a max of 50 mg during the procedure, targeting bispectral index (BIS) between 45%-60%. The lean body weight will be used for calculation of the drugs.
Drug: Opioid-sparing based anesthesia
Intraoperative sevoflurane-based anesthesia, 0.8 to 1.0 Minimum alveolar concentration will be used combined with fentanyl 1 mcg/kg followed by 1 -2 mcg/kg/h and cis-atracurium, to keep bispectral index between 45% to 60%.
Drug: Sevoflurane-based anesthesia
Intraoperative opioid-sparing maintenance comprised dexmedetomidine bolus dose of 1 mcg/kg followed by 0.3 mcg/kg/h, propofol 4-8 mg/kg/h and ketamine 25 mg/h for a max of 50 mg during the procedure, targeting bispectral index (BIS) between 45%-60%. The lean body weight will be used for calculation of the drugs.
Also known as: Opioid
Intraoperative sevoflurane-based anesthesia, 0.8 to 1.0 Minimum alveolar concentration will be used combined with fentanyl 1 mcg/kg followed by 1 -2 mcg/kg/h and cis-atracurium, to keep bispectral index between 45% to 60%.
Also known as: Sevoflurane
Incidence of Early postoperative hypoventilation
Early postoperative respiratory hypoventilation will be defined by any of the following parameters: Oxygen saturation \< 95% for 10 seconds. Respiratory rate \< 8 breath/min. Apnea spill \> 10 seconds. pain/sedation-mismatch.
Time frame: UP to 24 hours Postoperatively
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
Time frame: after the end of study for one year.
Access criteria: The data will be available upon a reasonable request from the corresponding author
No publications or documents are linked to this record.
Start is estimated for Aug 2023; primary completion for Mar 2024, 7 months later.
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This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Opioids · Sevoflurane