Clinical trial NCT06131905: Magnesium Sulfate as an Adjuvant to Propofol During Consious Sedation in Colonoscopy
Official title: Magnesium Sulfate as an Adjuvant to Propofol During Consious Sedation in Adult Patients Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Magnesium
Intraoperative Analgesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Colonoscopy is one of the most commonly performed outpatient procedures throughout the world as a screening, diagnostic, and therapeutic tool to evaluate the large intestine from the distal rectum to the cecum.Propofol is the most commonly used hypnotic agent in sedation during endoscopic procedures for its advantages of fast onset and quick recovery. However, propofol may cause respiratory depression and cardiovascular events, which are easier to appear in cases of old age and high speed administration of propofol.Magnesium is a non-specific calcium channel inhibitor and a non-competitive N-methyl-D-aspartate(NMDA)receptor antagonist, which has analgesic and mild sedative properties .

Detailed description: Colonoscopy is one of the most commonly performed outpatient procedures throughout the world as a screening, diagnostic, and therapeutic tool to evaluate the large intestine from the distal rectum to the cecum . Colonoscopy is currently an important examination method for colorectal diseases. It can provide clear images of lesions and provide biopsy for biopsy. It can improve the accuracy and sensitivity of colorectal cancer diagnosis .The most common complications in gastrointestinal endoscopy are not related to the procedure, but they are related to sedation; they include cardio- respiratory adverse events such as hypoxemia, hypoventilation, apnea, dysrhythmias, hypotension and vasovagal episodes .Propofol is the most commonly used hypnotic agent in sedation during endoscopic procedures for its advantages of fast onset and quick recovery. However, propofol may cause respiratory depression and cardiovascular events, which are easier to appear in cases of old age and high speed administration of propofol . Moreover, high doses of propofol may cause dose-dependent hemodynamic instability in older or feeble patients. Therefore, it is essential to minimize the dosage of propofol to prevent cardiopulmonary complications associated with sedation, especially in the elderly, by combining with an adjuvant medication. Although benzodiazepines or opioids combined with propofol can reduce the consumption of propofol, elderly patients usually feature a higher overall body fat content than younger patients which may delay the metabolism of lipid-soluble propofol, opioid, and benzodiazepines . Magnesium is the fourth most plentiful cation in the body and the second most plentiful intracellular cation after potassium. Approximately one half of total body magnesium is present in bone and 20% in skeletal muscle. Magnesium is necessary for the presynaptic release of acetylcholine from nerve endings and may produce effects similar to calcium-entry-blocking drugs . Magnesium is a non-specific calcium channel inhibitor and a non-competitive N-methyl-D-aspartate(NMDA)receptor antagonist, which has analgesic and mild sedative properties . It has been demonstrated that intravenous administration of magnesium sulfate can reduce the overall use of intraoperative propofol and the postoperative analgesia requirement effectively in various types of surgery .These findings implied that magnesium sulfate may be used as a promising adjuvant drug for colonoscopy sedation due to its analgesic and sedative properties .

Eligibility criteria: Inclusion Criteria:

* 1. The subject is scheduled for elective colonoscopy. 2. The subject is ≥ 40 years and ≤ 70 years. 3. Both sexes. 4.No obvious abnormalities in preoperative ECG, blood routine, electrolytes, and other tests. 5. ASA class 1-3.

Exclusion Criteria:

* 1.Subject is known or believed to be pregnant or lactating women. 2. Patients are known hypersensitivity to any of the drugs that would be used in the study. 3. Severe cardiac, renal, lung, or liver diseases. 4. Hypotension (systolic blood pressure\< 90 mm Hg), uncontrolled hypertension (systolic blood pressure\> 170 mmHg, diastolic blood pressure\> 100mmHg). 5. Chronic Opioid Use (daily or almost daily use of opioids for\> 3 months). 6. Patients that are immunologically compromised. 7. Sleep apnea syndrome or difficult airway. 8. preexisting hypoxemia (Spo2\< 90 %). 9. History of adverse events with prior sedation. Additionally, patients who had taken any sedative drugs within the previous 24h

Primary outcomes:
measure: Total consumption of propfol
timeFrame: During procedure
Secondary outcomes:
measure: sedation time
timeFrame: During procedure and One hour after procedure
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University
name: Essam Mohamed Manna, Professor
role: STUDY_CHAIR
affiliation: Assistant Professor of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University
name: Raja Ahmad Abdullah Mohamed
role: STUDY_DIRECTOR
References:
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