NCT01946763

Brief Summary

The recovery and emergences from anesthesia is a critical phase. Previous studies focused on pharmological and anesthetics techniques to improve the quality of this stage (duration, complications). In this study, our first aim is to test the impact of pre operative education on the post operative recovery for morbidly obese patient underwent laparoscopic bariatric surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

10 months

First QC Date

June 3, 2013

Last Update Submit

September 19, 2013

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Quality of anesthesia recovery

    6 hours

Study Arms (2)

safety of Anesthesia

NO INTERVENTION

No pre operative education

Behavioral : pre operative education

EXPERIMENTAL

Behavioral pre operative education

Behavioral: pre operative education

Interventions

pre operative educationBEHAVIORAL

Patients will be randomized in 2 groups (G1: educated, G2:non-educated) In the operating room and before starting anesthesia G1 will receive a pre operative education about anesthesia emergence, recovery and extubation.

Behavioral : pre operative education

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults more than 18 years old.
  • ASA 2.
  • BMI more than 35.
  • scheduled for laparoscopic sleeve gastrectomy or gastric bypass surgery.

You may not qualify if:

  • Renal impairment.
  • Hepatic dysfunction.
  • Alcohol or drug abuse.
  • Disabling Central nervous or cerebrovascular diseases.
  • Treatment with opioids or any psychoactive medication.
  • Inappropriate Mini mental state exam.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Procare Riaya Hospital

Khobar, Eastern Province, 31952, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ahed Zeidane, MD

    Procare Riaya Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

June 3, 2013

First Posted

September 20, 2013

Study Start

June 1, 2013

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

September 20, 2013

Record last verified: 2013-09

Locations

SA(1)