Hypotensive Anesthesia With Sleeve Gastrectomy

May 22, 2022 updated by: Alaa Mstafa Hassan Sewefy, Minia University

the Effect of Hypotensive Anesthesia With Sleeve Gastrectomy

to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive at the end

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive at the end of the operation to check bleeding

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61511
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hypotensive anesthesia
hypotensive anesthesia group
Procedure: hypotensive anesthesia
hypotensive anesthesia
Active Comparator: normotensive anesthesia
normotensive anesthesia group
Procedure: normotensive anesthesia
normotensive anesthesia group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: 20-120 minutes
operative time from skin to skin
20-120 minutes
intraoperative bleeding or oozing
Time Frame: 0-120 minute
intraoperative bleeding or oozing by the number of used gauzes and clips
0-120 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative bleeding
Time Frame: 2-36 hours
the incidence of postoperative bleeding
2-36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2021

Primary Completion (Actual)

May 3, 2022

Study Completion (Actual)

May 3, 2022

Study Registration Dates

First Submitted

December 11, 2021

First Submitted That Met QC Criteria

December 11, 2021

First Posted (Actual)

December 28, 2021

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 22, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fac.med 21.50

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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