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

NCT06131905 | Unknown Phase 2

• 1 other identifier: Magnesium in colonoscopy
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Magnesium; Intraoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• Total consumption of propfol

  Calculate the total dose of propofol used for each case

  During procedure

Secondary Outcomes (1)

• sedation time

  During procedure and One hour after procedure

Study Arms (2)

Group M (Magnesium sulfate+Propofol)

ACTIVE COMPARATOR

Includes thirdy patients receive 40mg /kg magnesium sulfate diluted with normal saline to a total volume of 100 ml 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

Drug: Magnesium Sulfate; Drug: Propofol

Group N (Propofol)

ACTIVE COMPARATOR

Includes thirdy patients receive an equal volume of normal saline as a placebo.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

Drug: Propofol

Interventions

Magnesium Sulfate DRUG

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

Group M (Magnesium sulfate+Propofol)

Propofol DRUG

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

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

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Liu J, Liu X, Peng LP, Ji R, Liu C, Li YQ. Efficacy and safety of intravenous lidocaine in propofol-based sedation for ERCP procedures: a prospective, randomized, double-blinded, controlled trial. Gastrointest Endosc. 2020 Aug;92(2):293-300. doi: 10.1016/j.gie.2020.02.050. Epub 2020 Mar 7.

  PMID: 32156544 BACKGROUND

• Lu Z, Li W, Chen H, Qian Y. Efficacy of a Dexmedetomidine-Remifentanil Combination Compared with a Midazolam-Remifentanil Combination for Conscious Sedation During Therapeutic Endoscopic Retrograde Cholangio-Pancreatography: A Prospective, Randomized, Single-Blinded Preliminary Trial. Dig Dis Sci. 2018 Jun;63(6):1633-1640. doi: 10.1007/s10620-018-5034-3. Epub 2018 Mar 29.

  PMID: 29594976 BACKGROUND

• Herroeder S, Schonherr ME, De Hert SG, Hollmann MW. Magnesium--essentials for anesthesiologists. Anesthesiology. 2011 Apr;114(4):971-93. doi: 10.1097/ALN.0b013e318210483d.

  PMID: 21364460 BACKGROUND

• Olgun B, Oguz G, Kaya M, Savli S, Eskicirak HE, Guney I, Kadiogullari N. The effects of magnesium sulphate on desflurane requirement, early recovery and postoperative analgesia in laparascopic cholecystectomy. Magnes Res. 2012 Jul;25(2):72-8. doi: 10.1684/mrh.2012.0315.

  PMID: 22728648 BACKGROUND

• De Oliveira GS, Bialek J, Fitzgerald P, Kim JY, McCarthy RJ. Systemic magnesium to improve quality of post-surgical recovery in outpatient segmental mastectomy: a randomized, double-blind, placebo-controlled trial. Magnes Res. 2013 Oct-Dec;26(4):156-64. doi: 10.1684/mrh.2014.0349.

  PMID: 24491463 BACKGROUND

• 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.

  PMID: 16278131 RESULT

• Wernli KJ, Brenner AT, Rutter CM, Inadomi JM. Risks Associated With Anesthesia Services During Colonoscopy. Gastroenterology. 2016 Apr;150(4):888-94; quiz e18. doi: 10.1053/j.gastro.2015.12.018. Epub 2015 Dec 18.

  PMID: 26709032 RESULT

• Cote GA, Hovis RM, Ansstas MA, Waldbaum L, Azar RR, Early DS, Edmundowicz SA, Mullady DK, Jonnalagadda SS. Incidence of sedation-related complications with propofol use during advanced endoscopic procedures. Clin Gastroenterol Hepatol. 2010 Feb;8(2):137-42. doi: 10.1016/j.cgh.2009.07.008. Epub 2009 Jul 14.

  PMID: 19607937 RESULT

MeSH Terms

Interventions

Magnesium Sulfate; Propofol

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Essam Mohamed Manna, Professor

  Professor of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University

  STUDY CHAIR

• Raja Ahmad Abdullah Mohamed

  Assistant Professor of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University

  STUDY DIRECTOR

Central Study Contacts

Mohamed Sayed Mahmoud Sayed, Master

CONTACT

01091383026; ms0109138@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 14, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 18, 2023

Record last verified: 2023-12