NCT05170711

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 11, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2022

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

December 11, 2021

Last Update Submit

May 22, 2022

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (2)

  • operative time

    operative time from skin to skin

    20-120 minutes

  • intraoperative bleeding or oozing

    intraoperative bleeding or oozing by the number of used gauzes and clips

    0-120 minute

Secondary Outcomes (1)

  • postoperative bleeding

    2-36 hours

Study Arms (2)

hypotensive anesthesia

EXPERIMENTAL

hypotensive anesthesia group

Procedure: hypotensive anesthesia

normotensive anesthesia

ACTIVE COMPARATOR

normotensive anesthesia group

Procedure: normotensive anesthesia

Interventions

hypotensive anesthesiaPROCEDURE

hypotensive anesthesia

hypotensive anesthesia
normotensive anesthesiaPROCEDURE

normotensive anesthesia group

normotensive anesthesia

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Minya, 61511, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor & consultant of general surgery, Department of Surgery

Study Record Dates

First Submitted

December 11, 2021

First Posted

December 28, 2021

Study Start

December 10, 2021

Primary Completion

May 3, 2022

Study Completion

May 3, 2022

Last Updated

May 24, 2022

Record last verified: 2022-05

Locations

EG(1)