Clinical trial

Magnesium Sulfate as an Adjuvant to Propofol During Consious Sedation in Adult Patients Undergoing Colonoscopy

NCT06131905

Name

Magnesium in colonoscopy

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.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 .

Trial arms

Trial start

2024-01-01

Estimated PCD

2025-01-01

Trial end

2025-12-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Magnesium Sulfate

40 mg/kg magnesium sulfate diluted with normal saline to a total volume of 100 ml was administered for 15 min.plus ,An initial bolus dose of 1 mg/kg propofol was administered over 30 is followed by a continuous intravenous infusion of propofol at a maintenance dose of 2 mg/kg/h

Arms:

Group M (Magnesium sulfate+Propofol)

Propofol

An initial bolus dose of 1 mg/kg propofol was administered over 30 is followed by a continuous intravenous infusion of propofol at a maintenance dose of 2 mg/kg/h

Arms:

Group M (Magnesium sulfate+Propofol), Group N (Propofol)

Size

Primary endpoint

Total consumption of propfol

During procedure

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-12-18

1 organization

2 products

2 indications

Organization

Product

Indication

Indication

Product