Sedation in Patients Undergoing GIT Endoscopy

Study Overview
=================
Brief Summary
-----------------
Comparison of propofol-nalbuphine and propofol-magnesium sulphate sedation for patients undergoing GIT endoscopy: a double-blind, randomized trial

Detailed Description
-----------------
Endoscopy plays a significant role in the diagnosis and treatment of gastrointestinal diseases. Sedation has been used in clinical practice to make the procedure more comfortable, and improve patient satisfaction by helping patients rest during the procedure. (1) (2) The most common complications in gastrointestinal endoscopy are not related to the procedure, but are related to sedation; they include cardio-respiratory adverse events such as hypoxemia, hypoventilation, apnea, dysrhythmias, hypotension and vaso-vagal episodes (3). Many studies have reported on use of propofol as a single agent for sedation during endoscopy. However propofol is often used in combination with another agent for other indications. The benefit of propofol in terms of shorter recovery and discharge times and higher patient satisfaction persists, when it is used in combination with other agents. Propofol has limited analgesic effect and higher doses are often required, when it is used as a single agent for endonoscopy, resulting in higher sedation levels. Thus use of propofol in combination with other agents may be preferable to propofol alone. The combination may be easier to manage due to lower sedation levels and ability to reverse some of the sedation with the use of reversal agents for narcotics (4).

Official Title
-----------------
Comparison of Propofol-Nalbuphine and Propofol-Magnesium Sulphate Sedation for Patients Undergoing GIT Endoscopy

Conditions
-----------------
Sedation for Patients Undergoing GIT Endoscopy

Intervention / Treatment
-----------------
* Drug: propofol and magnesium sulphate ,propofol and nalbuphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients scheduled for GIT endoscopy 2. Age 18-60 years old 3. ASA I-II. 4. BMI less than 30 Exclusion Criteria: 1. Heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.) 2. pulmonary disease (asthma, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, or lung cancer) 3. central nervous system abnormality 4. allergy to the study drugs 5. habitual sedative or analgesic use 6. pregnancy 7. Anticipated difficult airway.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol and nalbuphine group<br> | Drug: propofol and magnesium sulphate ,propofol and nalbuphine<br>* The patients will be randomly divided into 2 groups by using a computer-generated randomization tableAll patients will fast from solids for 8 h and from liquids for 2 h. After arrival at preoperative area an intravenous cannula will be placed in the peripheral vein of right hand for fluid infusion and medicine administration. All of the patients will be interviewed by the patient sedation satisfaction assessment tool (PSSI) regarding their experience 1 hour after the operation.<br>|
| Active Comparator: Propofol and magnesium sulfate group<br> | Drug: propofol and magnesium sulphate ,propofol and nalbuphine<br>* The patients will be randomly divided into 2 groups by using a computer-generated randomization tableAll patients will fast from solids for 8 h and from liquids for 2 h. After arrival at preoperative area an intravenous cannula will be placed in the peripheral vein of right hand for fluid infusion and medicine administration. All of the patients will be interviewed by the patient sedation satisfaction assessment tool (PSSI) regarding their experience 1 hour after the operation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of patient sedation | The level of patient sedation using Ramsay sedation agitation score (before induction of sedation (T0), 5 minutes after sedation (T1), 10 minutes after sedation (T2), and then every 30 minutes till complete recovery (T3, T4 and T5) to assess the depth of anesthesia. | the time of endoscopy |