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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01946763
• Other study ID #: PRH06
• Status: Recruiting
• Phase: N/A
• First received: June 3, 2013
• Last updated: September 19, 2013
• Start date: June 2013
• Est. completion date: May 2014

Study information

• Verified date: September 2013
• Source: Procare Riaya Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• pre operative education

Locations

Country	Name	City	State
Saudi Arabia	Procare Riaya Hospital	Alkhobar	Eastern Province

Sponsors (1)

Lead Sponsor	Collaborator
Procare Riaya Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of anesthesia recovery		6 hours	Yes