Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures

NCT ID: NCT04597268

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-12-30

Brief Summary

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This study aims to assess the safety and efficacy of dexmedetomidine versus ketamine versus midazolam combined with propofol in cancer patients undergoing gastrointestinal endoscopic procedures.

Detailed Description

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Comparison between using intravenous (IV) propofol combined with either IV dexmedetomidine or IV ketamine or IV midazolam; to study the effect of their combination on level of sedation and hemodynamic stability on adult patients scheduled for gastrointestinal endoscopic procedures.

Conditions

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Sedation and Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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dexmedetomidine

IV dexmedetomidine

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

intravenous dexmedetomidine 1 mic/kg

ketamine

IV ketamine

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

ketamine 1mg/kg

Midazolam

IV midazolam

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

midazolam 0.05 mg/kg

Interventions

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Dexmedetomidine

intravenous dexmedetomidine 1 mic/kg

Intervention Type DRUG

Ketamine

ketamine 1mg/kg

Intervention Type DRUG

Midazolam

midazolam 0.05 mg/kg

Intervention Type DRUG

Other Intervention Names

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propofol- dexmedetomidine propofol- ketamine propofol- midazolam

Eligibility Criteria

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Inclusion Criteria

* patients scheduled for gastrointestinal endoscopic procedures
* ≥ Age 18 years
* ASA I-II

Exclusion Criteria

* Allergy to any of the used drugs
* impaired renal or liver functions
* hypertensive patients
* patients with cardiovascular
* cerebrovascular disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Walaa Youssef Elsabeeny

Lecturer of anesthesia and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walaa Y Elsabeeny, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer

Nahla Y Shehab, MD

Role: STUDY_DIRECTOR

Lecturer

Locations

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Walaa Y Elsabeeny

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AP2007-50110

Identifier Type: -

Identifier Source: org_study_id

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