Propofol Versus the Use of Dexmedetomidine as a Sedative... | NCT03466632

Studies
Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Colonosopy

NCT03466632

Sponsor

Tanta University

Status

Unknown status

Last Update Posted

Mar 15, 2018Actual

Enrollment

100Estimated

Phase

Phase 3

Conditions

Colonic Diseases

Interventions

Propofol
Dexmedetomidine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2016Actual

Primary Completion Date

Apr 1, 2020Estimated

Completion Date

Apr 1, 2020Estimated

First Submitted Date

Mar 9, 2018

First Submission Date that Met QC Criteria

Mar 9, 2018

First Posted Date

Mar 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2018

Last Update Posted Date

Mar 15, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy

Detailed Description

Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
• Propofol Group	Active Comparator	propofol 1.5 mg/kg slow intravenously, followed by maintenance dose of 0.5 mg/kg/h throughout the procedure..	Drug: Propofol
• Dexmedetomidine Group	Active Comparator	dexmedetomidine 1 ug/kg over 10 minutes as a bolus dose followed by continuous infusion at a dose of 0.5 ug/kg/h as maintenance dose throughout the procedure	Drug: Dexmedetomidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propofol	Drug	propofol 1.5 mg/kg slow intravenously, followed by maintenance dose of 0.5 mg/kg/h throughout the procedure.	• Propofol Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with adequate sedation	the number of patients adequately sedated	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 25-45 years,
ASA class I or II,
who are scheduled for elective outpatient colonoscopy

Exclusion Criteria:

refused to give informed consent
if they had known hypersensitivity to the used drugs
patients with morbidly obese patients
patients with increased risk for airway obstruction as obstructive sleep apnea,
Liver diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief Abd-Elsalam, MD	Contact	00201095159522		sheriefabdelsalam@yahoo.com

Overall Officials

Name	Affiliation	Role
Sherief Abd-Elsalam, MD	Tanta University	Study Director
Sameh Abdelkhalek Ahmed, MD	Tanta University Anasthesia Department	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sameh Abdelkhalek Ahmed	Recruiting	Zagazig		35455	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003108	Colonic Diseases

Ancestor Terms

ID	Term
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided