Clinical trial NCT05880459: Sedation in Patients Undergoing GIT Endoscopy
Official title: Comparison of Propofol-Nalbuphine and Propofol-Magnesium Sulphate Sedation for Patients Undergoing GIT Endoscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Sedation for Patients Undergoing GIT Endoscopy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

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).

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.

Primary outcomes:
measure: The level of patient sedation
timeFrame: the time of endoscopy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hamdy Abbas Youssef, Professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Ola Mahmoud Wahba, Assistant Professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Khaled Tolba Younes, Lecturer
role: STUDY_DIRECTOR
References:
citation: Singh H, Poluha W, Cheung M, Choptain N, Baron KI, Taback SP. Propofol for sedation during colonoscopy. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD006268. doi: 10.1002/14651858.CD006268.pub2.
citation: Rex DK, Khalfan HK. Sedation and the technical performance of colonoscopy. Gastrointest Endosc Clin N Am. 2005 Oct;15(4):661-72. doi: 10.1016/j.giec.2005.08.003.
citation: Hinkelbein J, Lamperti M, Akeson J, Santos J, Costa J, De Robertis E, Longrois D, Novak-Jankovic V, Petrini F, Struys MMRF, Veyckemans F, Fuchs-Buder T, Fitzgerald R. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol. 2018 Jan;35(1):6-24. doi: 10.1097/EJA.0000000000000683.