Propofol Versus Dexmedetomidine for Sedation of Cancer Patients Undergoing ERCP

NCT06409104 | Completed DMC

• 1 other identifier: MS-211-2023
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the efficacy and safety of propofol and dexmedetomidine during ERCP regarding hemodynamic, respiratory, sedative and cognitive functions.

Conditions

Sedation in ERCP

Keywords

ERCP; Endoscopic; cancer; sedation; propofol; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Bispectral Index sedation Score

  \>90 indicates an awake patient; 71-90, mild to moderate sedation; 61-70, deep sedation; and 40-60, general anesthesia

  intraoperative

Secondary Outcomes (5)

• Change in heart rate during procedure

  intraoperative

• Change in MAP

  intraoperative

• Pain during procedure according to Facial Pain Rating Scale

  first 2hours postoperative

• Duration to recovery after the end of procedure

  first 2hours postoperative

• Total doses of both agents used

  intraoperative

Study Arms (2)

Propofol

ACTIVE COMPARATOR

will receive 1-2 mgkg-1 propofol injection over 30s followed by of propofol a 0.05 to 0.1 mg /kg/min infusion .

Drug: Propofol

Dexmedetomidine

ACTIVE COMPARATOR

will receive dexmedetomidine at a loading dose of 1 μg/kg over 10 min, followed by a 0.2-0.7-μg/kg/h infusion.

Drug: Dexmedetomidine

Interventions

Propofol DRUG

will receive 1-2 mgkg-1 propofol injection over 30s followed by of propofol a 0.05 to 0.1 mg /kg/min infusion

Propofol

Dexmedetomidine DRUG

will receive dexmedetomidine at a loading dose of 1 μg/kg over 10 min, followed by a 0.2-0.7-μg/kg/h infusion.

Dexmedetomidine

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age starting from 21 to 60 years.
• Genders eligible for study: males and females
• ASA II-III
• Undergoing ERCP
• to 30 kg/m2

You may not qualify if:

• Patient refusal
• Known allergy to drugs used in the study.
• Use of any anti-coagulants
• Neurological disorders
• Advanced liver or kidney disease
• Patient with psychiatric disorders

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Ahmed Mohamed Soliman

Giza, Egypt

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Propofol; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 101 patients. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * To compare hemodynamic profile of dexmedetomidine and Propfol during sedation in patients undergoing ERCP. * To study both agents effect on respiratory complications. * To demonstrate the effect of both drugs on cognitive functions. * To assess the effect of both drugs on duration of procedure and number of interruptions.

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: September 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

EG (1)