Enhanced Recovery After Surgey (ERAS)Guidelines in Mitral Valve Surgeries, Questionnaire
Conditions: ERAS
Sponsor: Cairo University

 
26/7/2022 
NCT05617768 
Study Title 
Enhanced Recovery After Surgery ( ERAS ) guidelines in Mitral valve 
surgeries , Questionnaire 
Research Protocol Template 
Anesthesia Research Scientific Committee 
 

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Table of Contents 
Introduction .................................................................................................................................................. 2 
Title Page ....................................................................................................................................................... 2 
Study Title ................................................................................................................................................. 2 
Investigators .............................................................................................................................................. 2 
Introduction .................................................................................................................................................. 3 
Aim of the work............................................................................................................................................. 3 
Objectives: .................................................................................................................................................... 3 
Hypothesis...................................................................................................... Error! Bookmark not defined. 
Ethical Considerations ................................................................................................................................... 4 
Methodology ................................................................................................................................................. 5 
I. 
Study design ...................................................................................................................................... 5 
II. 
Study setting and location ................................................................................................................ 5 
III. 
Study population ........................................................................................................................... 5 
IV. 
Eligibility Criteria ........................................................................................................................... 5 
1. 
Inclusion criteria ............................................................................................................................ 5 
2. 
Exclusion criteria ............................................................................ Error! Bookmark not defined. 
V. 
Study Procedures .............................................................................................................................. 5 
1. 
Randomization (in RCT only) ......................................................................................................... 5 
2. 
Study Protocol ................................................................................ Error! Bookmark not defined. 
3. 
Measurement tools ....................................................................................................................... 6 
VI. 
Study outcomes ............................................................................................................................ 6 
1. 
Primary outcome .......................................................................................................................... 6 
2. 
Secondary outcome(s) ................................................................... Error! Bookmark not defined. 
Statistical Analysis ......................................................................................................................................... 7 
I. 
Sample size ........................................................................................................................................ 7 
II. 
Statistical analysis ............................................................................................................................. 7 
References .................................................................................................................................................... 7 

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Title Page 
Study Title 
Enhanced Recovery After Surgery ( ERAS ) guidelines in Mitral valve surgeries , Questionnaire 
 
Investigators 
Candidate Details 
 
Name: Ahmed Mohamed Hussien 
Degree: Master degree 
Affiliation: National Heart Institute 
Phone No: 01013949803 
Email: dr.ahmed.elrom@gmail.com 
 
Principle Investigator 
 
Name and Affiliation: prof. Dr. Hisham Salah Mohamed Khedr 
Department: anesthesia and intensive care 
Email: hkhishamkhedr@gmail.com 
 
Co-investigator (A): 
 
Name & Affiliation: prof. Dr. Pierre Zarif Tawadros 
Department: anesthesia and intensive care 
Email: pierrezarif@gmail.com 
 
Co-investigator (B): 
 
Name & Affiliation: Dr. Sherif Mamdouh Abbas 
Department: anesthesia and intensive care 
Email: S25041989@hotmail.com 

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Our aim is to know how well cardiac anesthesiologists, cardiac intensivists and cardiothoracic 
surgeons know and apply ERAS protocol in mitral valve surgery. 
 
 
 
 
Introduction: 
 
 
Enhanced recovery after surgery (ERAS) is a term that include a series of evidence- 
based perioperative care pathways designed to reduce physiological and 
psychological stress in surgical patients and to achieve rapid recovery. 
In 2016, the first pilot study was published, which analyzed enhanced recovery after 
cardiac surgery (ERACS). Weaning from mechanical ventilation is considered one of 
the items that forms the concept of enhanced recovery in cardiac surgery. 
Pain is an undesirable consequence of surgery especially cardiac surgery as pain 
during and following cardiac surgery has been shown to be a risk factor for increased 
morbidity. Systemic opioids have been the main stay for the management of 
perioperative pain in cardiac surgery. Lower doses of opioids has been related 
to early extubation and minimizing opioid‐related side effects, such as prolonged 
ventilation, tolerance, nausea, vomiting, gut dysfunction, and immunosuppression. 
 
 
 
 
Aim of the work 
 
Objectives: 
We will use the questionnaire about ERAS guidlines to assess the knowledge of doctor about the 
guidelines. 
On the other hand we find cases of morbidity and mortality not related to the 
surgical procedure. ERAS protocol discuss the optimum condition that can we use to 
avoid the morbidity and mortality complications. 
We aim to know how well ERAS protocol is known and applied 

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Hypothesis: 
Our hypothesis is that ERAS guidelines are not well known among doctors. 
 
 
Ethical Considerations 
The study will be conducted after taking approval of the research and ethical committees. 
Informed consent will be obtained from study participants or their legally authorized 
representative. 

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 Anesthesia department, Cairo university hospitals, kasr al-ainy. 
 Cardiothoracic thoracic surgery department, Cairo university hospitals, kasr al-ainy. 
 Anesthesia department, National Heart Institute. 
 Cardiothoracic surgery department, National Heart Institute. 
 Cardiac anesthesiologists 
 Cardiac intensivists 
 Cardiothoracic surgeons 
Methodology 
 
I. 
Study design 
Cross section study to assess of knowledge about Enhance Recovery After Surgery 
(ERAS) guidelines between cardiac anesthesiologists, cardiac intensivists and 
cardiothoracic surgeons. 
II. 
Study setting and location 
 
III. 
Study population 
 
IV. 
Eligibility Criteria 
1. Inclusion criteria 
 Cardiac anesthesiologists. 
 Cardiac intensivists. 
 Cardiothoracic surgeons. 
 All stuff members from resident to consultant are included inside this study 
 
 
V. 
Study Procedures 
 
 
1. Randomization (in RCT only) 
A questionnaire will be sent online to a random sample of anesthesiologists and intensive care 
physicians. 
 The random sample will be taken by use of random list. 
 
2. Study Protocol: 

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Grading system will be described as:- 
 Grade A ( knows well ( : more than 60 % correct answer 
 Grade B ( fair ): 35 :60 % correct answer 
 Grade C ( knows nothing ) :- less than  35 % correct answer 
Assessement of the knowledge of doctors to ERAS guidelines in cardiac surgery by using the 
grading system. 
 
The questionnaire consists of number of questions that the doctor has to answer in a set 
format. It will be a closed-ended questions:- 
 Dichotomous 
 Nominal-polytomous 
 Ordinal-polytomous 
2. Measurement tools 
1. Questions about ERAS society 
 
2. Questions about premedications 
 
3. Questions about opioids 
 
4. Questions about ERAS guidelines :- 
 
 Preoperative Hb A1c measurement 
 Preoperative measurement of Albumin 
 Preoperative correction of nutritional deficiency 
 Consumption of clear liquid before GA 
 Preoperative carbohydrates loading 
 
 Prehabilitation 
 
VI. 
Study outcomes 
1. Primary outcome 
 
2. Secondary outcome(s) 
 

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- Population size = 1000 (cardiac anesthesiologists, cardiac intensivists and 
cardiothoracic surgeons in Cairo University hospitals ( Kasr Al Ainy ) and National 
Heart Institute  ). 
Statistical Analysis 
I. 
Sample size 
. 
The sample size had determined using epi-infoVersion 7 based on the following 
prerequisites: 
- Confidence level = 95% 
 
- Expected frequency of knowledge about Enhance Recovery After Surgery (ERAS) 
guidelines between cardiac anesthesiologists, cardiac intensivists and cardiothoracic 
surgeons = 50%. 
- Confidence limit =5% 
 
 
This gave a minimum sample size two hundred and seventy eight physicians had 
selected to be included in the study. 
II. 
Statistical analysis 
The collected data will be revised, coded and analyzed using SPSS version 21 
software for tabulation and analysis. 
The following statistical measures will be calculated: 
A. 
Descriptive statistics: 
1- Count and percentage. 
2- For quantitative variables, arithmetic mean and standard deviation will be 
calculated. 
B. 
Analytical statistics: 
The data will be analyzed and when p<0.05 will be considered statistically significant. 
 
 
References 
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Rockall TA, Schricker T, Carli F. Enhanced Recovery After Surgery (ERAS) for gastrointestinal 

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