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

September 19, 2013 updated by: Ahed ZEIDAN, Procare Riaya Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

80

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

  • Saudi Arabia
    • Eastern Province
      • Alkhobar, Eastern Province, Saudi Arabia, 31952
        • Recruiting
        • Procare Riaya Hospital
        • Contact:
        • Principal Investigator:
          • Ahed Zeidane, MD

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: safety of Anesthesia
No pre operative education
Experimental: Behavioral : pre operative education
Behavioral pre operative education
Behavioral: 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.
Behavioral: pre operative education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of anesthesia recovery
Time Frame: 6 hours
6 hours

Collaborators and Investigators

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

Sponsor

Procare Riaya Hospital

Investigators

  • Principal Investigator: Ahed Zeidane, MD, Procare Riaya Hospital

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

June 1, 2013

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

June 3, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (Estimate)

September 20, 2013

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • PRH06

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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