Back to resultsOpioid-sparing Versus Sevoflurane Anesthesia on Early Postoperative Hypoventilation in Laparoscopic Bariatric Surgery
Primary Purpose
Anesthesia, Hypoventilation, Opioid Use
Status
Not yet recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Opioid-sparing based anesthesia
Sevoflurane-based anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia
Eligibility Criteria
Inclusion Criteria: All adult patients ≥ 18 years Admitted to the post anesthesia care unit after bariatric surgery Exclusion Criteria: • Preoperative hypoxemia which is determined by a peripheral capillary oxygen saturation (SPO2) reading of < 90% on room air
Sites / Locations
- Tanta University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Opioid-sparing based anesthesia
Sevoflurane-based anesthesia
Arm Description
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.
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%.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05962671
Brief Title
Opioid-sparing Versus Sevoflurane Anesthesia on Early Postoperative Hypoventilation in Laparoscopic Bariatric Surgery
Official Title
Opioid-sparing Versus Sevoflurane-based Anesthesia on Early Postoperative Hypoventilation in Patients Undergoing Laparoscopic Bariatric Surgery: Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 10, 2023 (Anticipated)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Hypoventilation, Opioid Use, Bariatric Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Opioid-sparing based anesthesia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sevoflurane-based anesthesia
Arm Type
Active Comparator
Arm Description
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%.
Intervention Type
Drug
Intervention Name(s)
Opioid-sparing based anesthesia
Other Intervention Name(s)
Opioid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane-based anesthesia
Other Intervention Name(s)
Sevoflurane
Intervention Description
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%.
Primary Outcome Measure Information:
Title
Incidence of Early postoperative hypoventilation
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All adult patients ≥ 18 years
Admitted to the post anesthesia care unit after bariatric surgery
Exclusion Criteria:
• Preoperative hypoxemia which is determined by a peripheral capillary oxygen saturation (SPO2) reading of < 90% on room air
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samah M Marie, MBBCh
Phone
+20 120 745 203
Email
mohamedsamah084@gmail.com
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31527
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samah M Marie, MBBCH
Phone
+20 120 745 203
Email
mohamedsamah084@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD Sharing Time Frame
after the end of study for one year.
IPD Sharing Access Criteria
The data will be available upon a reasonable request from the corresponding author
Learn more about this trial
Opioid-sparing Versus Sevoflurane Anesthesia on Early Postoperative Hypoventilation in Laparoscopic Bariatric Surgery
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