Goal Directed Propofol Sedation With Magnesium Sulphate Versus Dexmedetomidine for ERCP Procedure

NCT02684019 | Completed Phase 3

• 1 other identifier: TBRI project (code number111A)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is an invasive longer endoscopic procedure. It is performed in remote locations under a continuum of anesthetic depth, ranging from conscious to deep sedation leading to general anesthesia. Propofol sedation for (ERCP) procedures is the most popular current technique that has generated controversy in the medical field. Propofol can be safely administered because of its shorter half-life which results in a shorter recovery time than conventional sedation (opioid and/or benzodiazepine) that makes it widely used for sedation in many gastrointestinal procedures including ERCP. However, because of its narrow therapeutic window, the level of conscious sedation can easily go deeper from moderately deep sedation to near general anesthesia. Therefore, propofol as a sole agent can cause oversedation and apnea. Depth of sedation could be estimated better when target effect concentration of propofol is titrated by using bispectral index monitoring device(BIS).Targeting BIS within a specific range ensures additional safety during the procedure. Scores between 60-80 have been recommended for sedation. Propofol requirement can be reduced with addition of adjuvants (eg. Ketamine, Magnesium sulfate and Dexmedetomidine). Most adjuncts have analgesic properties with opioid and anesthetic sparing effects, without clinically significant respiratory depression. Dexmedetomidine, is a selective alpha 2 agonist; it has sedative, amnestic, and analgesic properties. It is a useful addition to a propofol/remifentanil anesthetic combination as it reduced their requirements intraoperatively and can help supplement analgesia postoperatively. Its combination with propofol was proved to provide satisfactory anesthesia for upper gastrointestinal (GI)) endoscopy in obstructive sleep apnea patients . Magnesium can also act as an adjuvant in analgesia due to its properties as calcium channel blocker and N-methyl-D-aspartate antagonists .It was suggested to be a near ideal intravenous (IV) adjunct to propofol/ remifentanil based total anesthesia in gynaecology patients . Hypothesis of this study is that Magnesium sulfate can have a propofol sparing effect during ERCP procedures guided by BIS monitoring as efficient as dexmedetomidine but with less cost and complications together with more patient and doctor satisfaction in addition to better patient outcome.

Conditions

Lack of Drug Action

Keywords

Endoscopic retrograde cholangiopancreatography; sedation; dexmedetomidine; propofol; Magnesium sulphate; Bispectral index monitoring

Outcome Measures

Primary Outcomes (1)

• Total propofol consumption

  0.5-1.5 mg as induction dose guided by bispectral index between 60-70 followed by infusion ranged from 3-5 mg/kg/h keeping BIS between 60-70

  through study completion, an average of one hour

Secondary Outcomes (5)

• Mean arterial blood pressure

  through study completion, an average of one hour

• Time to discharge

  15 minutes

• Cost

  through study completion , an average of one hour

• Complication and side effects

  through study completion , an average of one hour

• Heart rate

  through study completion, an average of one hour

Other Outcomes (2)

• Patient satisfaction

  through study completion, an average of one hour

• Doctor satisfaction

  through study completion, an average of one hour

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

1microgram/kilogram loading dose followed by 0.5 microgram/kilogram/hour IV

Drug: Dexmedetomidine

Magnesium sulphate

ACTIVE COMPARATOR

40milligram/kilogram loading dose followed by 10milligram/kilogram/hour IV

Drug: Magnesium Sulphate

Interventions

Dexmedetomidine DRUG

added to propofol sedation

Also known as: Precedex

Dexmedetomidine

Magnesium Sulphate DRUG

added to propofol sedation

Magnesium sulphate

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) I, II or III.
• Body mass index (BMI) ˂30
• Patients scheduled for ERCP procedures

You may not qualify if:

• Obesity (BMI \>30)
• Evidence of hepatic encephalopathy, ascites.
• Sever renal, endocrine and respiratory dysfunction.
• Atrioventricular conductance disturbance.
• Symptomatic bradycardia \<35 bpm
• Hemodynamically unstable patients on inotropic support.
• Neurological disorders
• Myasthenia gravis.
• Hypo/Hyperkalemia (Potassium \<3meq/l or\>5.5meq/l) (risk of dysrhythmias).
• Chronic treatment with calcium channel blockers or magnesium
• Opioid or analgesic abuse
• Allergy to Propofol/ egg or any other study drugs.
• Pregnancy and lactation

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research Institute

Giza, 11221, Egypt

Location

Related Publications (6)

• Jeurnink SM, Steyerberg E, Kuipers E, Siersema P. The burden of endoscopic retrograde cholangiopancreatography (ERCP) performed with the patient under conscious sedation. Surg Endosc. 2012 Aug;26(8):2213-9. doi: 10.1007/s00464-012-2162-2.

  PMID: 22302536 RESULT

• Ramkiran S, Iyer SS, Dharmavaram S, Mohan CV, Balekudru A, Kunnavil R. BIS Targeted Propofol Sparing Effects of Dexmedetomidine Versus Ketamine in Outpatient ERCP: A Prospective Randomised Controlled Trial. J Clin Diagn Res. 2015 May;9(5):UC07-12. doi: 10.7860/JCDR/2015/12435.5991. Epub 2015 May 1.

  PMID: 26155536 RESULT

• Fluhr G, Mayerle J, Weber E, Aghdassi A, Simon P, Gress T, Seufferlein T, Mossner J, Stallmach A, Rosch T, Muller M, Siegmund B, Buchner-Steudel P, Zuber-Jerger I, Kantowski M, Hoffmeister A, Rosendahl J, Linhart T, Maul J, Czako L, Hegyi P, Kraft M, Engel G, Kohlmann T, Glitsch A, Pickartz T, Budde C, Nitsche C, Storck K, Lerch MM. Pre-study protocol MagPEP: a multicentre randomized controlled trial of magnesium sulphate in the prevention of post-ERCP pancreatitis. BMC Gastroenterol. 2013 Jan 15;13:11. doi: 10.1186/1471-230X-13-11.

  PMID: 23320650 RESULT

• James MF. Clinical use of magnesium infusions in anesthesia. Anesth Analg. 1992 Jan;74(1):129-36. doi: 10.1213/00000539-199201000-00021. No abstract available.

  PMID: 1734773 RESULT

• Wang D, Chen C, Chen J, Xu Y, Wang L, Zhu Z, Deng D, Chen J, Long A, Tang D, Liu J. The use of propofol as a sedative agent in gastrointestinal endoscopy: a meta-analysis. PLoS One. 2013;8(1):e53311. doi: 10.1371/journal.pone.0053311. Epub 2013 Jan 8.

  PMID: 23308191 RESULT

• Mukhopadhyay S, Niyogi M, Sarkar J, Mukhopadhyay BS, Halder SK. The dexmedetomidine "augmented" sedato analgesic cocktail: An effective approach for sedation in prolonged endoscopic retrograde cholangio-pancreatography. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):201-6. doi: 10.4103/0970-9185.155149.

  PMID: 25948901 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Hend H Kamel, Professor

  Theodor Bilharz Research Institute

  STUDY CHAIR

• Maher F Mahmoud, Professor

  Kasr El Aini hospital,Faculty of medicine, Cairo University,

  STUDY CHAIR

• Eslam A Mohamed, Lecturer

  Kasr El Aini hospital,Faculty of medicine, Cairo University,

  PRINCIPAL INVESTIGATOR

• Nabaweya M Kamal, Professor

  Theodor Bilharz Research Institute

  STUDY DIRECTOR

• Mohammed A Maher, Lecturer

  Theodor Bilharz Research Institute

  PRINCIPAL INVESTIGATOR

• Ahmed S Abd El Azeem, Residant

  Theodor Bilharz Research Institute

  PRINCIPAL INVESTIGATOR

• Khalda G Radwan, Professor

  Theodor Bilharz Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of anesthesiology

Model Details: Group M: the Drug consisted of 2 ampoules each one containing 2500 mg magnesium sulphate (Egypt Otsuka pharma.Co)in 50 ml syringe .(i.e. 100 mg/ml). Loading dose was 40mg/kg, given over 10min and maintenance dose was 10mg/kg/h. Group D: the Drug consisted of 2ml containing 200μg Dexmedetomidine (precedex®; united pharmaceutical group company, USA) diluted up to 50ml with normal saline (4μg/ml). Loading dose was 1μg/kg; given over 10min. The maintenance dose was 0.5 μg / kg / h.

Study Record Dates

• First Submitted: February 6, 2016
• First Posted: February 17, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)