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Does Pre-operative Patients' Education Facilitates Emergence of Anesthesia Following Bariatric Surgery?

NCT ID: NCT01946763

Last Updated: 2013-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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The purpose of our study is to compare post operative immediate recovery and emergence for educated and non educated morbidly obese patients underwent laparoscopic bariatric surgery.

Elligibles patients are informed and consented by anesthesiologist. Patients are randomized in 2 groups (G1: educated, G2:non-educated) Patient of G1 are educated in OR before starting anesthesia. This education includes : information about anesthesia emergence, recovery and extubation.

Anesthesia and education are conducted by the same anesthesiologist. All patients are operated by the same surgeon. All patients receive same balanced general anesthesia protocol. The recovery starts immediately after the end of the procedure, when the patient has BIS ≥90 and TOF≥9.

Recovery assessment and data recording is done by a blinded anesthesiologist.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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safety of Anesthesia

No pre operative education

Group Type NO_INTERVENTION

No interventions assigned to this group

Behavioral : pre operative education

Behavioral pre operative education

Group Type EXPERIMENTAL

pre operative education

Intervention Type BEHAVIORAL

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.

pre operative education

Intervention Type BEHAVIORAL

Interventions

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pre operative education

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.

Intervention Type BEHAVIORAL

pre operative education

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Procare Riaya Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahed ZEIDAN

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahed Zeidane, MD

Role: PRINCIPAL_INVESTIGATOR

Procare Riaya Hospital

Locations

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Procare Riaya Hospital

Khobar, Eastern Province, Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Facility Contacts

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Kamal Abdulkhaleq, MD

Role: primary

Other Identifiers

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PRH06

Identifier Type: -

Identifier Source: org_study_id