Back to resultsHypotensive Anesthesia With Sleeve Gastrectomy
Primary Purpose
Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
hypotensive anesthesia
normotensive anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid
Eligibility Criteria
Inclusion Criteria:
- obese patients with BMI more than 40 or more than 35 with comorbidity
- patients fit for laparoscopic surgery
- give approval to share in the study
Exclusion Criteria:
- patients refused to share in the study
- patients unfit for surgery
- patients aged less than 18 and older than 50
- patients with BMI less than 35
- patient with previous upper abdominal surgery either for obesity or other diseases
- patients with GERD
Sites / Locations
- Faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hypotensive anesthesia
normotensive anesthesia
Arm Description
hypotensive anesthesia group
normotensive anesthesia group
Outcomes
Primary Outcome Measures
operative time
operative time from skin to skin
intraoperative bleeding or oozing
intraoperative bleeding or oozing by the number of used gauzes and clips
Secondary Outcome Measures
postoperative bleeding
the incidence of postoperative bleeding
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05170711
Brief Title
Hypotensive Anesthesia With Sleeve Gastrectomy
Official Title
the Effect of Hypotensive Anesthesia With Sleeve Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
May 3, 2022 (Actual)
Study Completion Date
May 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive at the end
Detailed Description
to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive at the end of the operation to check bleeding
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hypotensive anesthesia
Arm Type
Experimental
Arm Description
hypotensive anesthesia group
Arm Title
normotensive anesthesia
Arm Type
Active Comparator
Arm Description
normotensive anesthesia group
Intervention Type
Procedure
Intervention Name(s)
hypotensive anesthesia
Intervention Description
hypotensive anesthesia
Intervention Type
Procedure
Intervention Name(s)
normotensive anesthesia
Intervention Description
normotensive anesthesia group
Primary Outcome Measure Information:
Title
operative time
Description
operative time from skin to skin
Time Frame
20-120 minutes
Title
intraoperative bleeding or oozing
Description
intraoperative bleeding or oozing by the number of used gauzes and clips
Time Frame
0-120 minute
Secondary Outcome Measure Information:
Title
postoperative bleeding
Description
the incidence of postoperative bleeding
Time Frame
2-36 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
obese patients with BMI more than 40 or more than 35 with comorbidity
patients fit for laparoscopic surgery
give approval to share in the study
Exclusion Criteria:
patients refused to share in the study
patients unfit for surgery
patients aged less than 18 and older than 50
patients with BMI less than 35
patient with previous upper abdominal surgery either for obesity or other diseases
patients with GERD
Facility Information:
Facility Name
Faculty of medicine
City
Minya
ZIP/Postal Code
61511
Country
Egypt
12. IPD Sharing Statement
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Hypotensive Anesthesia With Sleeve Gastrectomy
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